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OncoCyte Corporation (OCX)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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0.9778+0.0269 (+2.83%)
At close: 04:00PM EDT
0.9700 -0.01 (-0.80%)
After hours: 07:32PM EDT
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  • E
    Eduardo
    Whereis uncle??????
    Bearish
  • M
    Michael
    Just finished reading slides from last week's DetermaVu presentation. A few new important learnings for me. Thought I'd share for others who have not studied the info yet. Won't go over all items, but if you are investing or considering doing so, highly recommend you read the slide pack here: https://investors.oncocyte.com/events-and-presentations

    Important things I discovered:

    1) Capital on hand sufficient to reach commercialization (direct from their slide)

    2) There is a pathway to commercialization that does not involve the FDA because it is a LDT (Lab Diagnostic Test). OncoCyte is choosing this path and avoiding FDA because they claim for DetermaVu, it will offer no advantage in terms of adoption or reimbursement.

    3) The data reported last week was from their R&D lab blind study. To go with the non-FDA pathway, they must conduct confirmation testing in a CLIA approved facility. CLIA stands for Clinical Laboratory Improvement Amendments which as best I can tell assures proper equipment and procedures are used in testing. Slides say OncoCyte has a CLIA facility certification since Aug 2017. (Why they did not do the R&D work in the CLIA facility I do not know)

    4) Once they validate the R&D results we know with the CLIA results, assuming they are consistent, there are a couple of other "clinical" steps shown in slide. Not sure if they are in scope before commercialization in 2H 2019 or done co-currently.

    5) When I was researching this CLIA business, I found this: The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. (What this suggests to me is that Medicare and Medicaid would be onboard with the test validated in CLIA facility)

    Hope this was helpful......!
    Events & Presentations
    Events & Presentations
    investors.oncocyte.com
  • M
    Michael
    Last week, this message board had some good postings and comments about the news OncoCyte presented during 29 Jan conf call with accompanying slide package. There has been much discussion about about the approval process, and whether FDA approval is needed for gov't and private payers to reimburse for DetermaVu.

    I have documented in a posting here about 5 days ago what my understanding on this topic based on the slides posted by OCX at the time of conf call. The important slides were the last two, slide 24 (Validation Plan for DetermaVu) and 25 (CLIA Regulatory Pathway in Place). You can find a slide pack PDF here: https://investors.oncocyte.com/events-and-presentations

    You can see in my previous posting that I was still not clear some details, so today, I called Investor Relations. What I am about to write is my understanding of what Investor Relations said (declaimer). Here is what I learned:

    1) OCX is indeed going to avoid FDA as shown in slide 25 and go commercial with CLIA confirmation (see my prior posting for CLIA details)

    2) Slide 24 lists 5 steps for complete validation. The first two items are complete with this 29 Jan report. The third step is the CLIA lab confirmation which is now to take place. (I heard scientist in conf call say should have that done by "mid-year")

    3) Once the third step CLIA work is complete (assuming successful), they are ready to proceed with commercialization. His take on timing would be late 2019 to be reaching out to the 6000 or so Pulmonologist community.

    4) It is recognized that automatic acceptance by Medicare/Medicaid and private insurers is not going to happen right away. They expect some approval by exception will happen on a case by case basis depending on patient/doctor requests. It could take an additional 18 to 24 months after commercialization to achieve the automatic approval status.

    5) Slide 24, steps 4 and 5 of the validation process will take place after commercialization as data is gained in early users. It is the completion of step 5 (Clinical Utility) that forms the basis for insurers' automatic acceptance should it be warranted by utility results.

    So, my take on bottomline: 1) Figure an announcement in the summer with CLIA results. 2) Announcement of commercialization beginning in the fall. 3) Early 2020 to get some prelim sales data. 4) During 2020-2021, get more sales and some performance data. 5) If all goes well, in 2022 get the big bucks with automatic approval status. Of course all of this could be interrupted at any time with a buyout offer.
    Events & Presentations
    Events & Presentations
    investors.oncocyte.com
  • C
    Chris
    KeyBanc analyst Paul Knight initiated coverage of OncoCyte with an Overweight rating and $5 price target. OncoCyte has gone from a pre-commerical and pre-revenue diagnostic company to one that is commercial and now generating revenue with its recent CMS approval of DetermaRx, noted Knight, who thinks that multiple expansion is warranted as revenue builds and the company sees traction in its commercial efforts
  • C
    Chris
    OncoCyte price target raised to $7.50 from $5.40 at Piper Sandler Piper Sandler analyst Steven Mah raised the firm's price target on OncoCyte to $7.50 from $5.40 and keeps an Overweight rating on the shares after taking over coverage of the name. OncoCyte is building a "broad" oncology care platform anchored by two potentially best-in-class lung cancer tests, Mah tells investors in a research note. The analyst is confident the company's roll-up strategy can drive long-term value.
    Bullish
  • s
    silverman
    Will hold for longer term. This type of test and results does not come by often.
    4.7 B addressable market.
  • I
    Info
    OncoCyte Corporation
    Supplement to Proxy Statement
    ANNUAL MEETING OF SHAREHOLDERS
    To Be Held on Wednesday, July 17, 2019
    This Supplement to our Proxy Statement for our Annual Meeting of Shareholders to be
    held on July 17, 2019 consolidates certain information concerning the number of directors and
    employees who may participate in our 2018 Equity Incentive Plan (the “Plan”). As disclosed in
    our Proxy Statement, there are currently seven members of our Board of Directors, and as
    disclosed in our Annual Report on Form 10-K that accompanies our Proxy Statement, as of
    December 31, 2018 we employed 12 persons on a full-time basis.
    Of course the number of our employees will vary from time to time. For example we
    recently hired two new Vice Presidents for marketing and managing our CLIA lab, and it is
    likely that we will add other employees for new product development and commercialization if
    we successfully complete development and commence commercialization of our lung cancer
    confirmatory test DetermaVu™, and we may add other administrative personnel as the need
    arises. We engage consultants from time to time, and generally have had between four and seven
    individuals providing consulting services this year, and although we may grant consultants
    equity awards under the Plan we have no plans to do so at this time. Also, as disclosed in our
    Proxy Statement, if our shareholders approve the proposed amendment of our Bylaws permitting
    us to have as many as ten directors, the number of directors may increase in the future as well.
    June 26, 2019
  • s
    silverman
    From 8-K

    ALAMEDA, Calif., January 29, 2018 – OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, today announced positive results from its key R&D Validation study demonstrating the accuracy of the Company’s DetermaVu™ liquid biopsy test for lung cancer.



    The R&D Validation study demonstrated a sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI 68%-81%) of DetermaVu™ on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators. Sensitivity is the percentage of malignant nodules that are correctly identified and specificity is the percentage of benign nodules correctly identified. A 95% confidence interval (CI) suggests that there is a 95% chance that final test performance will be within the stated range.



    These results show that DetermaVuTM significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and that DetermaVuTM clearly outperforms reported results from competitors’ tests and other clinical models. Based on this strong performance, OncoCyte believes that DetermaVuTM is the best-in-class lung cancer liquid biopsy diagnostic test. OncoCyte plans to make DetermaVuTM commercially available in the second half of 2019, with the goal of fundamentally changing the way lung cancer is diagnosed.



    Notably, OncoCyte obtained these results without including any clinical factors in the DetermaVu™ algorithm, underscoring the strength of the test. DetermaVu™ measures biomarkers of the immune system’s response to cancer to differentiate between malignant and benign lung nodules in early stage lung cancer. Because clinical data points, such as lung nodule size, provide a significant amount of the diagnostic power for liquid biopsy lung cancer tests developed by other companies, the superior accuracy of DetermaVu™ independent of any clinical factors reinforces its strength as a differential diagnostic tool for early lung cancer detection, and provides physicians with significant biologic information that has not been available prior to DetermaVu™.



    DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a recent Medicare study, cost on average $14,634 each. In addition, DetermaVu™ can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.
  • B
    Brian
    June 18, 2019
    Dear Fellow Shareholders:
    In the past year since our last shareholder update, your company has undergone some major changes and has made significant progress advancing DetermaVu™, our liquid biopsy test for the early detection of lung cancer. We now have line-of-sight to commercial availability for a lung cancer diagnostic test in a market that we estimate to be worth between $2.0 billion to $4.7 billion depending on final clinical indications and reimbursement.
    Over the fourth quarter of 2018, we successfully completed a 700-blood sample Algorithm Development study that was designed to establish a proprietary mathematical algorithm that will be used to interpret DetermaVu™ test results. Following the completion of the Algorithm Development study, we moved immediately into the R&D Validation study to determine the test’s accuracy. The results of this study were encouraging: sensitivity of 90% and specificity of 75%, in a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.
    An important nuance to note is that these results were achieved without the use of clinical factors such as nodule size, a parameter that is required input in many other cancer tests . Having a test that is independent of clinical factors is differentiating in the market and these results significantly exceed the parameters that we believe are required to have a commercially viable lung cancer diagnostic test.
    Our ability to detect the presence of cancer utilizing only biomarkers of the immune system’s response to cancer, a process we call Immune System Interrogation , is a true breakthrough in the field of cancer diagnostics, and if the strength of our biomarker set continues to play out in our future clinical endpoint studies, we will have the opportunity to expand the utility of this exciting technology. While our near-term priority is to make the DetermaVu™ lung test commercially available as expeditiously as possible, we believe the technology has potential utility in other cancer types as well. To that end, in parallel with our commercial preparations we are expanding our research and development activities and broadening our pipeline beyond lung cancer.
    Recently, we also announced a change in senior leadership at OncoCyte, and I feel extremely fortunate to be stepping into such an incredible opportunity as your CEO. I also want to thank Bill Annett for his solid leadership and tireless effort to bring us to this point. We expect that Bill will remain as an advisor to the company for the foreseeable future to help in strategic business development activities.
    In closing, we believe DetermaVu™ represents a true paradigm shift in lung cancer diagnostics, one that can prevent unnecessary lung biopsies which are both risky to patients and costly for payers. We are pleased with our progress to date and excited for what the future holds. I would like to thank our employees who worked tirelessly to get us to this point, and you, our shareholders, for your continued support. I look forward to keeping you apprised of our continued progress as well as our future strategy for expanding our technology into new exciting areas of cancer diagnostics.

    Respectfully,

    Ron A. Andrews, Jr.
    Chief Executive Officer
  • T
    Todd
    Great news for OCX. IMO has potential for massive gains in 2021.
    Oncocyte Announces Definitive Agreement to Acquire Chronix Biomedical, Inc.
    https://quantisnow.com/insight/339473?s=s
    Quantisnow
    quantisnow.com
    Bullish
  • S
    Some Dude
    Oncocyte has received its first diagnostic revenues from commercial payers

    Submission of Medicare claims has commenced following final reimbursement decision

    Test volumes continue to increase each month

    IRVINE, Calif., June 15, 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 its transition to a revenue generating, commercial stage company. Oncocyte has received reimbursement for DetermaRx™ from multiple commercial payers. In addition, Oncocyte has submitted its first claims for DetermaRx under the Centers for Medicare & Medicaid Services (CMS) reimbursement program.

    DetermaRx is the first and only predictive test for the identification of patients with Stage I-IIA non-squamous NSCLC who are at high-risk for recurrence following surgery and are likely to be responsive to adjuvant chemotherapy. The test previously received a final local coverage decision from Palmetto (a Medicare Administrative Contractor for CMS). DetermaRx was launched early this year under an early access program.

    “Our transition to a revenue generating company is a significant step in Oncocyte’s evolution,” said Ron Andrews, CEO of Oncocyte. “We are encouraged that, in addition to Palmetto’s decision to cover DetermaRx for Medicare patients, private payers have also begun to reimburse this important test. We believe this transition is an important validation of DetermaRx’s potential to improve both the clinical outcomes and the healthcare economics of treating early stage lung cancer patients. It also marks the beginning of an important new revenue stream for Oncocyte. We are thrilled that our test volumes continue to increase month over month, with momentum from physician prescribers in multiple states and across both public and private payers. We will continue our efforts with both the medical community and payers to ensure that this potentially life-saving test is widely adopted and broadly reimbursed, while also continuing to advance the development of our other tests that have the potential to significantly improve patient outcomes and improve the economics of cancer treatment.”

    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. DetermaDx™, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify if a patients’ lung nodules are benign, which may enable them to avoid potentially risky invasive diagnostic procedures. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies. DetermaDx, DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.
  • S
    Some Dude
    From the 5/18/20 proxy filing

    To approve an amendment to our Articles of Incorporation to increase the total number of authorized shares of common stock, no par value, that we may issue from 85,000,000 shares to 150,000,000 shares (the “Common Stock Amendment”);

    Our Board of Directors believes that the proposed increase in the number of authorized shares of Common Stock is desirable in order to enhance our flexibility in taking possible future actions, such as raising additional equity capital, making acquisitions using our equity as consideration, awarding equity compensation or pursuing other corporate purposes. As of May 12, 2020, we had 67,217,906 shares of Common Stock issued and outstanding, approximately 9,608,000 shares of Common Stock reserved for issuance upon the exercise of outstanding stock options and upon vesting of restricted stock units, approximately 4,155,000 shares of our common stock available for future grants under our Incentive Plan and 3,383,913 shares of Common Stock reserved for issuance upon the exercise of outstanding stock purchase warrants, leaving only approximately 635,000 shares of Common Stock available to Oncocyte for use in raising capital, making acquisitions, or pursuing other corporate purposes. Oncocyte has not yet received significant revenues from the cancer diagnostic tests that it is developing and commercializing, and until such time as it is able to do so and to generate sufficient revenue to finance its operations, it will need to raise additional capital, which may occur through the sale of Common Stock, preferred stock, and securities convertible into or exercisable for shares of Common Stock or preferred stock.



    28



    We have issued or agreed to issue shares of Common Stock to acquire assets to expand our technology and product portfolios and we may issue or sell shares of Common Stock in the future to acquire additional assets or businesses. We consider potential sources of financing and potential acquisition candidates from time to time when opportunities arise. We have agreed to issue shares of Common Stock to the stockholders of Razor Genomics, Inc. (“Razor”), as described below, if certain conditions are met under agreements related to the acquisition of shares of Razor and rights to develop and market our DetermaRx™ diagnostic test. If the Common Stock Amendment Proposal is not approved by our shareholders, we might not be able to meet our contractual obligations to the Razor shareholders. We may, at our election, also issue shares of Common Stock in lieu of cash to former shareholders of Insight Genetics, Inc. (“Insight”), as described below, under the terms of a merger agreement pursuant to which Oncocyte acquired the cancer assays that we are developing as DetermaIO™.



    We have also entered into an Equity Distribution Agreement with Piper Sandler & Co. pursuant to which we may offer and sell shares of Common Stock from time to time for cash in “at-the-market” transactions. We are not presently a party of any other financing or acquisition agreements that require us to issue, or pursuant to which we may issue, shares of Common Stock, and we may not be able to raise capital or consummate future acquisitions on terms we deem acceptable, or at all.
  • M
    Michael
    Listened to the conference call at 5pm EDT. The first question asked was, "What happened? It gave good results in development trials, but not in validation." Answer was......we're not sure! They are going to do a post failure autopsy, but no plans to spend any more resources to develop the test.

    I can only guess that using the lab samples to develop the diagnostic algorithms in research phase resulted in some curve fitting that didn't pan out in real world testing. I think a lot of us investors failed to understand the level of failure risk in this step. Just figured if it worked in research lab, it should work in clinical setting. I think we lacked company input the risk involved.
  • D
    David
    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.
    Bullish
  • T
    Todd
    The rights offering is great news for the longs! and looks like the market likes it a lot!
  • A
    Anonymous
    i got this from investor relations

    Bob Yedid (LifeSci Advisors)
    Tue 7/2/2019 11:39 AM
    The shareholders at BioTime sold A block of stock at the open at two dollars per share. This was done by a shareholder and not by the company and Was not disclosed to us in advance. We are exploring with the lawyers what we can say.
  • s
    silverman
    FDA Activity on laboratory developed tests (LDTs)-

    FDA on Laboratory Developed Tests

    "The FDA has generally not enforced premarket review and other applicable FDA requirements because LDTs were relatively simple lab tests and generally available on a limited basis. Due to advances in technology and business models, LDTs have evolved and proliferated significantly since the FDA first obtained comprehensive authority to regulate all in vitro diagnostics as devices in 1976. Some LDTs are now much more complex, have a nationwide reach and present higher risks, such as detection of risk for breast cancer and Alzheimer’s disease, which are similar to those of other IVDs that have undergone premarket review.

    The FDA has identified problems with several high-risk LDTs including: claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death. The FDA is aware of faulty LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease.

    In 2010, the FDA announced its intent to reconsider its policy of enforcement discretion for LDTs and held a workshop to obtain input from stakeholders on such policy. FDA used this feedback to develop an initial draft approach for LDT oversight and published draft guidance in 2014. FDA solicited feedback on on the draft LDT framework and notification guidances as well as held a public workshop.

    In gathering feedback on the LDT draft guidances issued in 2014, we continuously engaged with interested stakeholders, including those groups that authored alternative proposals. We analyzed more than 300 sets of comments on the draft guidances and discussion from a subsequent public workshop held in 2015 as well as engaged in many meetings and conferences with various stakeholders. In the absence of issuing final guidance and at the request of stakeholders, we feel it is our responsibility to share our synthesis of all the feedback we have received, with the hope that it advances public discussion on future LDT oversight.

    To this end, on January 13, 2017, the FDA issued a discussion paper on LDTs. The synthesis does not represent the formal position of FDA, nor is it enforceable. We hope to simply advance the public discussion by providing a possible approach to spur further dialogue."
  • m
    michael
    Why the surprise? There are no revenues, no earnings. Yet. This stock will either be $50 in 2 years, or 5 cents. I'm guessing $50. Insiders in the company own 48% of the stock. I doubt they would be holding on to that high numbers of shares if they didn't have great confidence in their product. Good luck jumping in when good news hits. It will be fast and furious.
  • M
    Michael
    With the mid-year update, is it only more time they are letting us know about? When I dissect the statement issued today regarding CLIA validation study, I see phrases like: "ongoing efforts to create consistency in this process", "continue its development work", "CLIA lab staff are working diligently to analyze and address", "once these teams have made progress with these remaining steps, management intends to provide an update on the timing."

    This all smacks of a technical problem around getting consistent results and thus far not achieving "validation." Sounds like they are working to develop solutions, and don't know how long it will take. But, they'll let us know once they figure it out.

    Guess if you are confident they can solve their issues before they lose the market to competitors, hang tight or even buy more. But, if you've been around this stock a while, you'll remember this is not their first surprise technical stumble. If your confidence in their ability to pull this commercialization off is dwindling, maybe it's timing to reduce risk.
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