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Oncocyte and the Guardian Research Network® Announce Strategic Alliance

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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 trials

IRVINE, 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 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.

About the Guardian Research Network

Guardian 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 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.

Oncocyte Investor Contact
Bob Yedid
LifeSci Advisors, LLC

Oncocyte Media Contact
Cait Williamson, Ph.D.
LifeSci Communications, LLC

GRN Media Contact
Charlene Smith-McCaw, MBA
Charlene Smith-McCaw Consulting, Marketing & Communications