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OncoCyte Corporation (OCX)

NYSE American - NYSE American Delayed Price. Currency in USD
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1.6900+0.1000 (+6.29%)
At close: 4:00PM EDT

1.5700 -0.12 (-7.10%)
After hours: 6:34PM EDT

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Previous Close1.5900
Open1.5800
Bid1.6000 x 1400
Ask1.6800 x 1000
Day's Range1.5500 - 1.6900
52 Week Range1.1500 - 3.5100
Volume463,793
Avg. Volume1,263,675
Market Cap113.654M
Beta (5Y Monthly)2.30
PE Ratio (TTM)N/A
EPS (TTM)-0.5140
Earnings DateNov 12, 2020 - Nov 16, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est3.10
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  • Oncocyte Announces Third Quarter Growth of DetermaRx™ Physician Adoption and Testing Volume
    GlobeNewswire

    Oncocyte Announces Third Quarter Growth of DetermaRx™ Physician Adoption and Testing Volume

    Testing volume for DetermaRx more than doubled in Q3 2020 Growing hospital and physician adoption at large community practices and National Comprehensive Cancer Network (NCCN) and NCI-designated cancer centersEntered agreement with GenCell, an oncology-focused commercial distributor for key Latin American countriesIRVINE, Calif., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today provided an update on DetermaRx’s global growth and adoption. DetermaRx is a treatment stratification test that identifies stage I-IIA non-small cell lung cancer (NSCLC) patients at high risk of recurrence, despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. Since DetermaRx was commercially launched in the U.S. in January, it has begun to be reimbursed by Medicare and multiple private payers. It has seen rapid adoption in its first year of launch across 67 hospitals, including the National Comprehensive Cancer Network (NCCN) and National Cancer Institute (NCI) cancer centers.Key third quarter DetermaRx growth metrics: * Testing volume of DetermaRx more than doubled from the second quarter to 175 billable samples. * Maintained a re-order rate of ~60%. * Onboarded hospitals increased to 67, including prestigious National Comprehensive Cancer Network (NCCN) and National Cancer Institute (NCI) cancer centers. * DetermaRx adoption has expanded at major healthcare systems, including HCA Healthcare, Cancer Treatment Centers of America (CTCA), Florida Cancer Specialists (FCS), Scripps Health, and Providence Cancer Institute. * DetermaRx is now approved to be incorporated in the standard testing menu at a very influential NCI center as well as FCS, one of the largest cancer centers in Florida. * Expanded international distribution of DetermaRx through an agreement with GenCell, a specialized oncology diagnostics distributor with operations in Mexico, Colombia, and Brazil, effective September 10, 2020. “We are encouraged by the increasing quarter-over-quarter growth of DetermaRx,” said Padma Sundar, Head of Commercial at Oncocyte. “Our rapid growth is taking place across all important metrics, such as test volume, reorder rate, inclusion in hospital ordering systems, and test adoption at premiere community practices as well as prestigious National Cancer Institute (NCI) designated cancer centers and National Comprehensive Network Cancer (NCCN) centers. We believe the rapid adoption of DetermaRx reflects the significant clinical need for this test, which is the only test currently available to drive critical treatment decisions for early-stage lung cancer patients who may be at risk for recurrence. Our compelling new prospective data demonstrate that treatment informed by DetermaRx significantly improves lung cancer patient survival, and we believe this test could be practice-changing, potentially guiding the use of not only chemotherapy but also the use of targeted therapies in the future.”DetermaRx, Oncocyte’s first commercially launched clinical test, is the first of Oncocyte’s three current engines of revenue growth. DetermaIO™, Oncocyte’s gene expression test for selecting patients who may benefit from immune therapy, is the second growth engine. This test is currently available for research use only, and it provides revenue to Oncocyte through its use in conjunction with clinical trials. Oncocyte anticipates DetermaIO to be commercially launched for clinical use in the second half of 2021. Oncocyte’s third revenue generator is its Pharma Services business, which provides molecular testing for pharmaceutical companies conducting clinical trials for emerging therapies. Pharma Services also provides platform and content development services for molecular diagnostic companies. Oncocyte’s Pharma Services business has seen significant revenue growth since DetermaIO was CLIA-validated for research use in March. Together, these growth pillars represent a solid foundation for Oncocyte’s plan to drive rapid revenue growth over the next year, reducing the Company’s cash usage and driving the business toward profitability.Commenting on the Company’s progress, CEO Ron Andrews said, “We continue to be very enthusiastic about the progress we are making across all of our growth engines. The third-quarter volume growth of DetermaRx is very encouraging. It complements the growth across our DetermaIO and Pharma Services businesses in research markets. The strategy we put in place to expand our proprietary test menu and Pharma Services over the last twelve months is now paying off in revenue growth that can reduce our cash usage over coming quarters. Today’s announcement of our Latin America distribution agreement with GenCell adds another solid, oncology-focused partner to help us begin to tap into the large global market opportunity we anticipate for DetermaRx.”  Q1Q2Q3 Cumulative Sites Onboarded143667 Physician Reorder RateNot Tracked~60%~60% Billable Patients Tested3364175   About Oncocyte Corporation Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum. The Company’s proprietary tests and pharmaceutical company services aim to save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while driving the growth of its revenue. Oncocyte recently launched DetermaRx™, a treatment stratification test to identify early-stage lung cancer patients who are at high risk for cancer recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients who are more likely to respond to checkpoint inhibitor immunotherapies. The Company also plans to launch Therasure™-CNI MONITOR, a blood-based immune therapy monitoring test. Oncocyte’s pharmaceutical company services help pharmaceutical companies to develop new cancer treatments, many of which may be linked to Oncocyte’s diagnostic tests.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation. Therasure is a trademark of Chronix Biomedical Inc.Oncocyte Forward-Looking Statements Oncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, pharmaceutical services, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, licensing, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.com

  • GlobeNewswire

    Oncocyte Announces New Prospective Data Demonstrating That Treatment Informed by DetermaRx™ Significantly Improves Lung Cancer Patient Survival

    Data to be Presented by Dr. Gavitt Woodard of Yale University at the IASLC 2020 North America Conference on Lung Cancer Results and Clinical Utility to be Discussed During KOL Webinar on October 22nd at 11:00 am PT featuring Dr. Woodard and Dr. David Gandara of UC DavisIRVINE, Calif., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that new prospective data on DetermaRx™ will be presented at the IASLC 2020 North America Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. These data will be presented by Gavitt Woodard, M.D., Assistant Professor, Yale School of Medicine, and lead author on the study. DetermaRx is a treatment stratification test that identifies stage I-IIA non-small cell lung cancer (NSCLC) patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. The test is reimbursed by Medicare and has seen rapid adoption in its first year of launch across seventy hospitals, including National Comprehensive Cancer Network (NCCN) and National Cancer Institute (NCI) cancer centers.Presentation highlights from the prospective study of 250 consecutive stage I-IIA non-squamous NSCLC patients that received the DetermaRx test include: * High-risk status as identified by the DetermaRx test was used to inform the use of adjuvant chemotherapy, and strikingly, 94% of patients who selected adjuvant chemotherapy were cancer-free after five years of follow-up. In contrast, one in three high-risk patients who elected to forego chemotherapy had a recurrence. * No DetermaRx-identified low-risk patients were treated with chemotherapy, and only 5% of them reported a cancer recurrence, suggesting that this test may also inform the choice to avoid potentially unnecessary but toxic chemotherapy. * These data expand and reinforce the strong survival benefit previously demonstrated in the first 100 patient study previously published. * EGFR status was not prognostic when data was evaluated in a cohort of 150 patients * DetermaRx identified high-risk patients who responded to adjuvant chemotherapy, independent of EGFR status * Data presented at the annual ASCO meeting from the ADUARA trial, reported improved survival rates in surgically resected NSCLC patients with an EGFR mutation treated with the targeted therapy osimertinib (Tagrisso®) These results inform the usage of the targeted therapy osimertinib in conjunction with chemotherapy, in EGFR positive patients.“We are very pleased that the initial data showing this test’s impact on cancer recurrence was maintained in the 250-patient expanded data set. This result establishes DetermaRx as the post-surgical treatment standard for patients diagnosed with NSCLC,” said Dr. Edgardo S. Santos, M.D., Florida Precision Oncology, a Division of Genesis Care and an early adopter of the test. “The integration of testing for targeted therapy, including EGFR mutation status and chemotherapy selection by DetermaRx on the same sample, will enable oncologists to optimize and sequence treatment post-surgery. In my opinion, these two tests together close the few remaining gaps that we currently face in deciding adjuvant therapy for early-stage adenocarcinoma of the lung. With these results, I would feel confident initiating chemotherapy, followed by targeted therapy for the EGFR-positive, DetermaRx high-risk patients I see in my practice.”Key takeaways include: * Combining DetermaRx risk status with EGFR mutation status may help inform optimal treatment strategies for non-small cell lung cancer (NSCLC) patients who are EGFR-mutation-positive. * DetermaRx may inform the usage of chemotherapy, in addition to osimertinib, in the approximately 33% of EGFR positive patients who DetermaRx also identified as high-risk for cancer recurrence. * Given these data, Oncocyte will be offering EGFR mutation testing and DetermaRx on the same sample starting this quarter. Padma Sundar, Senior Vice President, Commercial at Oncocyte, commented, “Coming off a very strong third quarter (during which we received final Medicare pricing within our expected range, and saw DetermaRx order volumes more than double from the second quarter), we are extremely excited about the release of the new prospective data. We believe these data expand the utility of DetermaRx for both chemotherapy and targeted therapy selection, ultimately facilitating continued rapid market adoption. As DetermaRx is the only validated test for guiding standard of care adjuvant chemotherapy post-surgery, we will continue to add other actionable markers to our testing as more therapy options become available for these patients. The addition of EGFR testing for osimertinib is an exciting first step in that direction.”Results from the study will be discussed at a KOL webinar on October 22nd at 11:00 am PT led by Gavitt Woodard, M.D., Assistant Professor, Yale School of Medicine, cardiothoracic surgeon and lead author on the study, and David Gandara, M.D., Professor of Medicine Emeritus at the University of California, Davis, and Director of Thoracic Oncology at the UC Davis Comprehensive Cancer Center (UCDCCC).For more details on the webinar and to register, please click here.About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum. The Company’s proprietary tests and pharmaceutical services aim to save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while driving the growth of its revenue. Oncocyte recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high-risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint inhibitor and other immunotherapies. To strengthen the Company’s immune therapy diagnostic offering, Oncocyte recently announced plans to commercialize Therasure-CNI, a tumor naïve blood based test licensed from Chronix Bioscience, which has shown effectiveness at monitoring the efficacy of immune therapy. The Company also has a growing pharmaceutical services business to help pharmaceutical companies with biomarker development for new cancer treatments, some of which may be linked to Oncocyte’s diagnostic tests.  DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.Oncocyte Forward Looking StatementsOncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, pharmaceutical services, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.com

  • GlobeNewswire

    Oncocyte and Fondazione Michelangelo, a Leading Non-Profit Cancer Research Foundation, Announce Immune Therapy Biomarker Collaboration

    Investigator-sponsored trial to evaluate DetermaIO™ as a biomarker of neoadjuvant checkpoint inhibitor response in triple-negative breast cancer (TNBC)Collaboration to generate near-term pharmaceutical services revenue for Oncocyte, and may facilitate a path to U.S. clinical launch in 2H2021 IRVINE, Calif., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced a strategic collaboration with the Fondazione Michelangelo (FM) in Milan, Italy to evaluate DetermaIO™ as a biomarker for response in the NeoTRIPaPDL1 trial (NCT02620280). The biomarker trial is a prospectively designed, retrospective study of archived study material from the therapeutic trial in triple-negative breast cancer (TNBC), one of the new frontiers for immune therapy treatment.At recently held scientific conferences, The Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019 and American Society of Clinical Oncology Annual Meeting (ASCO) 2020, researchers from the West Clinic and MD Anderson Cancer Center, respectively, presented results on the predictive performance of DetermaIO in response to PD-1 therapies in advanced non-small cell lung cancer (NSCLC) and TNBC. In these initial studies, the test outperformed the two currently available biomarkers, PD-L1 and TMB, most commonly used to inform patient selection for immunotherapy.Dr. Luca Gianni president of FM said, “The data presented at both ASCO and SITC are very promising and suggest that DetermaIO may enable the identification and selection of TNBC patients who are most likely to benefit from checkpoint inhibitors. We continue our pursuit of a definitive biomarker for the appropriate selection of patients for immune therapy in TNBC and are enthusiastic about our new collaboration with Oncocyte. We are very hopeful that DetermaIO’s ability to comprehensively assess the tumor microenvironment will improve patient stratification and, ultimately, contribute to better tailored administration of immune-checkpoint therapy.”“We are excited to be partnering with Fondazione Michelangelo as we seek to establish the clinical validity of DetermaIO in TNBC, a form of breast cancer where patients have minimal options to impact clinical outcomes,” said Dr. Doug Ross, Chief Medical Officer of Oncocyte. “Based on the success of our previous studies with checkpoint inhibitors in TNBC, we believe that the comprehensive information provided by the DetermaIO gene expression signature, when compared to current patient selection strategies, will enable more appropriate identification of patients who are expected to be most responsive to IO treatment.”Ron Andrews, CEO of Oncocyte, added, “This relationship adds to our growing list of partners and expands our ongoing work in patient stratification for TNBC and NSCLC clinical trials. These types of partnerships are strategically important to expanding the use of DetermaIO and are one of our four revenue growth engines that we believe will lead to our increasing revenue growth over time. Oncocyte sees significant opportunity for DetermaIO to penetrate the potential ~$3B testing market for immunotherapy patient selection. In the U.S. alone, it is estimated that approximately 750,000 solid tumor patients may be eligible to receive immunotherapies, yet no robust test is available to clearly identify which patients are most likely to benefit from these costly therapeutics. The interest in DetermaIO from prestigious researchers like the team at the Fondazione Michelangelo is indicative of momentum that could drive the test to the clinical market possibly as soon as late 2021.”DetermaIO is Oncocyte’s proprietary gene expression signature test that evaluates the tumor immune microenvironment from a biopsy sample. The test stratifies patients according to their likelihood of responding to immunotherapy. Currently, DetermaIO is available for biopharma diagnostic development and research use only. The Company believes it has significant potential for use as a companion test to select patients for clinical trials and, ultimately, as a full companion diagnostic for clinical use with immunotherapies in patient management.About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum. The Company’s proprietary tests and pharmaceutical services aim to save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while driving the growth of its revenue. Oncocyte recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint inhibitor immunotherapies. The Company’s pharmaceutical services help pharmaceutical companies to develop new cancer treatments, some of which may be linked to Oncocyte’s diagnostic tests.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.About Fondazione MichelangeloFondazione Michelangelo is a scientific non-profit organization for advancement in cancer research and treatment. It was founded by the internationally renowned leading oncologist Gianni Bonadonna in December 1999, and was officially recognized as a non-profit organization by the Italian Government in March 2001. The headquarters of the Fondazione are in Milan, Italy.The main aims of Fondazione Michelangelo are in the areas of research and education \- To promote and independently conduct new research projects to improve therapeutic options in hematological and solid tumors \- To translate the clinical and therapeutic results into clinical practice and favor their widest availability and applicability \- To share the know-how on designing and conducting clinical and translational studies with third partiesOncocyte Forward Looking StatementsOncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.com

  • GlobeNewswire

    Oncocyte Agrees to Enter Licensing and Collaboration Agreement with Chronix Biomedical

    Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it has agreed to enter a licensing and collaboration agreement with Chronix Biomedical. Oncocyte is licensing Chronix’s patented CNI Monitor technology for the TheraSure™-CNI MONITOR clinical assay.

  • GlobeNewswire

    Rockwell Medical Announces Appointment of Russell L. Skibsted as Executive Vice President, Chief Financial Officer and Chief Business Officer

    WIXOM, Mich., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the appointment of Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer (“CFO”) and Chief Business Officer (“CBO”), effective today, September 15, 2020. In this new role, Mr. Skibsted will be responsible for business development, financial operations and investor relations for the Company and will oversee the Finance and Accounting, Legal and Compliance, and Human Resources and Administration functions, reporting to the Chief Executive Officer and Board of Directors."We are pleased to announce Russell’s appointment as CFO and CBO of Rockwell Medical. His more than two decades of life sciences industry executive experience, including roles as CFO and CBO of publicly-traded biotechnology companies, are an excellent match for our Company as we focus on transforming our business through executing our commercial and worldwide business development strategy for Triferic and Triferic AVNU in kidney dialysis, and prioritize the development potential of our FPC platform to address iron deficiency and iron deficiency anemia in other medical indications,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “Russell will be a dynamic contributor to our leadership team, and we warmly welcome him to the Company."“I am honored to join Rockwell Medical at this pivotal time for the Company and look forward to working with the executive team and other stakeholders to strategically advance the business and bring value to patients and stockholders,” said Mr. Skibsted.Mr. Skibsted is a seasoned executive with more than 25 years of experience in finance, global business development, capital raising, investor relations, and operations. He has worked with a variety of both public and private life sciences companies, from commercial stage, development stage and start up. Prior to joining Rockwell, he served as CFO of AgeX Therapeutics (NYSE American: AGE), a biotechnology company focused on cell therapy targeting the diseases of aging that was spun out of BioTime, Inc. (currently Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX)). Previously, Mr. Skibsted served as CFO of BioTime, Inc., a publicly-traded biotechnology company which he joined in 2015, where he simultaneously, from time to time, performed the role of Chief Financial Officer for several of BioTime’s public and private subsidiaries, including Agex Therapeutics, OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer (November 2015 through November 2017) and Asterias Biotherapeutics, Inc., a biotechnology company pioneering the field of regenerative medicine with clinical programs in spinal cord injury and oncology immunotherapy (March 2016 through November 2016). Prior to BioTime, Mr. Skibsted served as CFO or Chief Business Officer for several public and private life science companies, including Proove Biosciences, Aeolus Pharmaceuticals, Spectrum Pharmaceuticals and Hana Biosciences. From time to time, he also acted as a consulting CFO to various life science companies as Managing Director of RSL Ventures. Earlier in his career, Mr. Skibsted held roles as Portfolio Management Partner and CFO at Asset Management Company, one of the oldest and most respected venture capital firms in Silicon Valley, and Vice President for GE Capital Services Structured Finance Group. Mr. Skibsted holds a B.A. in Economics from Claremont McKenna College and an M.B.A. from the Stanford Graduate School of Business.About Rockwell Medical Rockwell Medical is a biopharmaceutical company dedicated to transforming anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company’s initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.About Triferic Dialysate and Triferic AVNUTriferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.Triferic Dialysate and Triferic AVNU both deliver approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintain hemoglobin without increasing iron stores (ferritin). Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood which is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no reports of anaphylaxis in over 1,000,000 patient administrations, addressing a significant medical need in overcoming Functional Iron Deficiency (FID) in ESKD patients.Important Safety Information Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving Triferic in two randomized clinical trials.Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).Triferic® is a registered trademark of Rockwell Medical, Inc.Notice of Issuance of Inducement GrantsPursuant to his employment agreement, Mr. Skibsted will be awarded stock-based compensation representing the right to acquire shares of common stock (the “Inducement Grants”). The Inducement Grants will consist of options to purchase up to 750,000 shares of common stock, subject to 600,000 of which are subject to time-based vesting conditions and 150,000 of which are subject to performance-based vesting conditions. The Inducement Grants will be issued upon Mr. Skibsted’s commencement of employment (the “Grant Date”), and all stock options included within the Inducement Grants will have an exercise price equal to the fair value of the common stock on the Grant Date. The Inducement Grants have been approved by the Company’s Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company’s stockholder-approved equity incentive plans as an inducement grant, in accordance with Nasdaq Listing Rule 5635(c)(4).CONTACTS Investors: Argot Partners 212.600.1902 Rockwell@argotpartners.comMedia: David Rosen Argot Partners 212.600.1902 david.rosen@argotpartners.com

  • GlobeNewswire

    Oncocyte to Participate at the Lake Street Capital Markets 4th Annual Best Ideas Growth Conference

    IRVINE, Calif., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that Ronald Andrews, Chief Executive Officer, and Doug Ross, MD., Ph.D., Chief Medical Officer, will participate at the upcoming Lake Street Capital Markets 4th Annual Best Ideas Growth Conference, being held virtually on September 17, 2020. About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.comSource: Oncocyte Corporation

  • GlobeNewswire

    Oncocyte Receives Final Pricing Decision for DetermaRx™ Molecular Test for Lung Cancer from Centers for Medicare and Medicaid Services

    Pricing in line with comparable high-value molecular tests for oncology indications Consistent growth in testing volumes now provides immediate and consistent revenue for OncocyteDetermaRx is the only test available today for therapeutic decisions in early stage NSCLC, addressing an estimated global market of $450M - $500MIRVINE, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it has received a pricing decision from Centers for Medicare and Medicaid Services (CMS) for DetermaRx™, the Company’s treatment stratification test that identifies which early stage lung cancer patients are at high risk for lung cancer recurrence post-surgery. This is the first and only testing available for this indication.The pricing decision is in line with similar high-value molecular tests in oncology and is within the range of the Company’s previously communicated pricing expectations. This CMS pricing decision establishes an immediate path to consistent revenue growth for Oncocyte. In addition, Oncocyte already has begun to receive payment from commercial payers including Blue Shield of California, Cigna and Anthem. The Company believes that the receipt of the final Medicare local coverage determination (LCD) for DetermaRx™, announced on July 20, 2020, and the receipt of this pricing decision, will drive favorable payment decisions from additional commercial payors.“This CMS pricing decision provides important validation of DetermaRx’s ability to improve patient outcomes and healthcare economics,” said Ron Andrews, Chief Executive Officer and President of Oncocyte. “We are thrilled to have received a pricing decision in line with our expectations, and we continue to be encouraged by the solid market uptake of the DetermaRx test. Despite the current headwinds created by the COVID-19 pandemic, we are on track to test between 250 to 300 patient samples by year end, which is representative of 100% quarter over quarter growth. With this pricing decision and the continued growth in orders, DetermaRx represents a rapidly growing source of revenue and cash flow for Oncocyte.”Mr. Andrews continued, “Medicare patients account for approximately 70 percent of eligible patients for DetermaRx, and we are pleased to be able to provide this important, potentially life-saving test to Medicare patients at no out-of-pocket cost. We are also excited by the growing support of key opinion leaders, which in combination with the high value pricing, we believe will provide a catalyst to increase our sales efforts around the world to take advantage of our first-mover status in the test’s approximately $450M - $500M global market opportunity, subject to pricing and adoption rates. We look forward to building on this success as we continue to expand the adoption of DetermaRx while also advancing our commercially available for research use test, DetermaIO™, toward clinical use in 2021.”In published clinical studies, patients identified as high risk by DetermaRx who did not receive chemotherapy treatment had a 49% five year disease free survival rate versus a 92% five year disease free survival rate for those who were high risk and received a standard chemotherapy, a significant improvement. Conversely, in these studies, none of the low risk patients received chemotherapy. These low-risk patients reported a 94% five year disease-free survival rate, which suggests that DetermaRx may also help low risk patients avoid the toxic side effects associated with unnecessary chemotherapy.Physician adoption of DetermaRx has continued to grow throughout 2020 despite the continued challenges associated with the global COVID-19 pandemic. Through August, Oncocyte has onboarded 55 hospitals across the United States, increasing the number of onboarded accounts by 60 percent since the second quarter of 2020. In addition, the test is already included in the diagnostic ordering systems of several large community health center networks, including Florida Cancer Specialists & Research Institute. DetermaRx test volume has grown rapidly since it was commercialized early in 2020, and the Company projects third quarter volumes to grow approximately 100 percent compared to second quarter volumes. The physician reorder rate has remained consistently high, and was approximately 60 percent through August.The table below summarizes the hospital adoption, physician adoption and volume growth of DetermaRx since its commercialization early in 2020. It is provided for illustrative purposes only. Revenue recognition and cash payments to Oncocyte are determined by accounting principles and contractual agreements, and therefore do not necessarily correlate with volume statistics during individual quarters.  Q1 2020Q2 2020July and August Cumulative sites onboarded 143655 Physician reorder rate Not Tracked60%~60% Billable Patients tested 3364Tracking to 100% QoverQ growth About DetermaRxDetermaRx is the first and only predictive test for the identification of patients with Stage I-IIA non-squamous non-small cell lung cancer who are at high risk for recurrence following surgery and who may benefit from adjuvant chemotherapy.There are an estimated 40,000 Stage I and IIA non squamous NSCLC patients in the United States each year. With an estimated 350,000 patients potentially eligible for the test on an annual basis globally, the Company believes there may be a total addressable market opportunity of approximately $450M to $500 million for the test, subject to pricing and adoption rates. Oncocyte recently announced that it has agreements in place for the distribution of the test in India, the Middle East, Africa and Israel.About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.Oncocyte Forward Looking StatementsOncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.com

  • GlobeNewswire

    Oncocyte and the Guardian Research Network® Announce Strategic Alliance

    Collaboration establishes an integrated platform for precision medicine clinical trials, combining Oncocyte’s proprietary molecular tests and fully certified pharma services lab with GRN’s nationwide hospital consortium of 150 hospitals, clinical trial networks and real-world evidence data technology to establish an integrated precision medicine trial platform Initially focused on immuno-oncology, including Oncocyte’s proprietary DetermaIO™ test, which can be used to select patients for immune therapy clinical trialsIRVINE, Calif., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, and the Guardian Research Network® (GRN), a nationwide hospital consortium bringing access to cutting-edge trials and real world evidence clinical research to its community hospital members, today announced a strategic collaboration to create a comprehensive solution for pharma clients from patient recruitment to regulatory approvals. Oncocyte and GRN aim to leverage their joint capabilities by bringing together GRN’s clinical trial enrollment and data science technology with Oncocyte’s proprietary molecular tests, including DetermaRx™ for early stage lung cancer and DetermaIO™ for immunotherapy selection, as well as Oncocyte’s pharma and companion diagnostic development services. The collaboration is designed to reduce the time to populate immune targeting trials while also improving chances for successful trials through proprietary molecular patient stratification.“Despite the challenging macroenvironment, we continue to experience solid growth in our business initiatives through August, including increasing test volume of our DetermaRx product for early stage lung cancer as well as growing momentum in our pharma services business. Our alliance with GRN may help us to expand our pharma services offerings and increase DetermaIO’s use in more clinical trials for immune therapy patient selection,” said Ron Andrews, Chief Executive Officer and President of Oncocyte. “This collaboration with GRN enables us to help streamline clinical trial enrollment for pharmaceutical company sponsors and ideally positions us to provide comprehensive services needed by emerging biopharma companies that are developing new immune-oncology and targeted therapies. With well over 50 emerging second generation immune therapeutics entering various phases of clinical trials, this collaboration has significant potential to optimize patient recruitment in the immuno-oncology space by identifying the patients most likely to respond to treatment. We believe the combination of GRN’s large and growing network of community and regional hospitals, with Oncocyte’s CSR/ISO certified molecular laboratory and groundbreaking diagnostic technology, can deliver powerful value by accelerating new cancer drugs’ path to market. Today we are thrilled to announce our alliance with GRN, which we anticipate will deliver both near term successes and long term benefits for both parties.” Dr. Mark L. Watson, Chief Operating Officer of Guardian Research Network, added, “The Guardian Research Network is excited to work with Oncocyte to develop a new offering that provides turnkey service to emerging biopharma clients developing next generation immuno-oncology therapeutics. This partnership fits perfectly with GRN’s mission to bring the best new drugs and technologies to our network of forward-looking community hospital partners. We believe Oncocyte’s proprietary molecular tests, companion diagnostic development expertise, and regulatory access will enable the implementation of precision medicine-based patient stratification and the democratization of access to cutting edge molecular medicine in the community setting. We are thrilled to partner with Oncocyte’s leadership team with their demonstrated commitment to the community setting and look forward to combining our cutting-edge data technology with a clinical trial opportunity that benefits pharma partners, doctors and patients.”GRN is a consortium of over 150 hospitals and clinics focusing on executing clinical trials for oncology. The network has relationships with esteemed hospitals across the U.S. and works to facilitate clinical trial activities, including patient identification and study design optimization. Oncocyte’s molecular tools and diagnostic assays, specifically DetermaIO, its multivariate gene expression test which can identify immune checkpoint inhibitor responders, will allow GRN to optimize enrollment and support the development of next generation immune therapies. The collaboration will additionally allow Oncocyte to expand its relationships with pharmaceutical and biotechnology companies and apply its technology more broadly across research settings.About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.About the Guardian Research NetworkGuardian Research Network is a nation-wide, oncology-centered hospital consortium focused on accelerating clinical trials in under-served communities locally and regionally. Through our highly secure, HIPAA compliant data warehouse and data analytics tools, GRN has accelerated patient identification, optimized study design, and expanded the understanding of real-world trends in oncology care. From a patient privacy perspective, GRN requires HIPAA compliant relationships with all hospitals in its network. This regulatory framework allows GRN to perform a diverse array of clinical activities, including IRB approved study design optimization as well as projects involving Protected Health Information (PHI) such as patient care coordination and clinical trial enrollment. GRN has enrolled over 4,000 subjects in clinical trials in approximately four years. GRN's experienced clinical informatics team provides hospital networks and biopharma clients with proprietary artificial intelligence to derive new cancer insights from millions of records. Clinical trials support includes customized synthetic control groups, novel real-time trial enrollment analytics and integrated clinical research platforms—all to bring patients cutting-edge trial opportunities and potential cancer cures that improve lives. For more information on this 501(c)(3) nonprofit organization headquartered in Spartanburg, South Carolina, visit www.guardianresearch.org.Oncocyte Forward Looking StatementsOncocyte cautions you that this press release contains forward-looking statements.  Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO,  unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls,  greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Oncocyte Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comOncocyte Media Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 646-751-4366 cait@lifescicomms.comGRN Media Contact Charlene Smith-McCaw, MBA Charlene Smith-McCaw Consulting, Marketing & Communications 610-857-8048 charlenemccaw1@gmail.com

  • ACCESSWIRE

    Oncocyte to Present at the LD 500 Virtual Conference

    LOS ANGELES, CA / ACCESSWIRE / September 1, 2020 / Oncocyte (NYSE American:OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it will be presenting at the LD 500 investor conference on Thursday, September 3rd at 12:20PM PST / 3:20PM EST.

  • GlobeNewswire

    Oncocyte Announces Addition of Experienced Healthcare Executive, Jennifer Carter, MD, MPH, MBA to Board of Directors

    IRVINE, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced the appointment of Jennifer Levin Carter, MD, MPH, MBA to its Board of Directors. “Dr. Carter is a true pioneer in applying precision medicine in the world of oncology,” said Cavan Redmond, Chairman of the Board of Oncocyte. “Her work at N-of-One® was instrumental in advancing a new paradigm in cancer treatment which harnessed the power of molecular panels to correlate, and ultimately improve patient outcomes. Dr. Carter’s deep expertise and understanding in this domain will be invaluable at Oncocyte as we push forward into the world of immunotherapy to leverage targeted response prediction and patient selection in both the clinic and Pharma services opportunities.”Dr. Carter added, “I’m honored to join the Board of Directors at Oncocyte and believe that their growing suite of molecular tests has the potential to markedly improve patient outcomes through a precision approach that identifies the right treatment for each patient. I look forward to leveraging my experience in developing molecular guided treatment strategies to advance Oncocyte’s rapid growth and physician adoption. Their strategic approach in identifying critical underserved decision points for patients has led to the development of two important tests for response prediction in NSCLC and now for immunotherapy, and I am thrilled to collaborate with the board and management as we work to broaden the patient population and partners that will benefit from these critically important tests.”Dr. Jennifer Levin Carter is a healthcare executive, board member and entrepreneur and was most recently VP, Head of Precision Health at Integral Health, A Flagship Pioneering company. She has founded and served as CEO at healthcare companies including N-of-One®, Inc., where she was CEO from 2008-2012 and Chief Medical Officer from 2012 until its acquisition in 2019. At N-of-One, Dr. Carter led the creation of award-winning solutions that delivered novel treatment strategies to hundreds of thousands of patients with cancer globally.In addition to her board appointment for Oncocyte, Jennifer serves as a Director of DFP Healthcare Acquisitions Corp.; on the Board of Directors of HouseWorks, LLC., a home healthcare company, eCaring, Inc., a digital health home care platform and Target Cancer Foundation where she has worked closely with the Executive Director on the design and launch of a precision medicine clinical trial for patients with rare cancer. She is a Founding Strategic Board member of XSphera Biosciences, Inc., an Ex Vivo Immuno-oncology diagnostic company and on the Director’s Advisory Board at Smilow Cancer Hospital at Yale University. She is an Advisor and has consulted for numerous healthcare and life sciences startups and venture-backed companies on strategy, product development, business model design and fund raising.About Oncocyte Corporation Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.Oncocyte Forward Looking Statements Oncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the commercial launch of DetermaRx, development of DetermaIO, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Investor Contact Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.comMedia Contact Cait Williamson, Ph.D. LifeSci Communications, LLC 656-751-4366 cait@lifescicomms.com