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OncoCyte Corporation (OCX)
NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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r. Andrews owns over 65,000 units of Oncocyte stock worth over $984,375 and over the last 9 years he sold OCX stock worth over $0. In addition, he makes $2,102,210 as President, Chief Executive Officer, and Director at Oncocyte.
Past week has been great time to accumulate. TP $6 by end of year.
When is the dilute I can smell it!! What do they do all day at icx but swipe tinder
A couple of years ago i was so compelled to invest in OCX because of their promising liquid biopsy tests. I know you all must have been as disappointed as I was when that didnt work out. This is for all who still think that liquid biopsies for cancers and others will have a huge impact. Check this out
It’s time fir a dilute!! The Ocx must pay Ronnie asbury’s sakary
Time fir a dilute to pay officer salaries!! What do they do sll day besides surf the internet
ok i think this is the low. . .time 2 get in half of my position size at 4.9
I am in it for the long, I do not panic sell. True the stock has had it down trends, most do. I am up over 200%. just about recovered all of Wednesdays loss. Patience is key. Money is made by others if you sell early. You make money if you hold. True there are losing stocks, this is not one of those.
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:
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
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:
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
OncoCyte said it has licensed a lung cancer test to China’s Burning Rock Biotech. Check the disclaimer on the landing page. Likewise, these other companies could have a diversified product line that might be game-changing for ground forces. They seem to be a likely lucrative market. These other companies could be a great business to look into. Check this out:
Adding Intelligence to Tactical Weapon. See What Everyone Is Talking About
Adding Intelligence to Tactical Weapon. See What Everyone Is Talking About
Will hold for longer term. This type of test and results does not come by often.
4.7 B addressable market.
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.
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
what a tough white knuckle trade this is. struggling 2 scratch this trade w/ my 4.89 & 4.91 entries. . .here kitty kitty. . .daytrading is a tough gig. . .some days u make $1000 per hour some days u r way below minimum wage but as long as u consistently bag 7% to 14 % intraday gains and limit yourself to 2% max drawdowns you can afford to only be right 40% of the time and still pay your bills, go to a bunch of Angels and Clippers game and trade forever without having 2 go work 4 the man bkuz u r the man!!!
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
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.
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.
Ron A. Andrews, Jr.
Chief Executive Officer
Great news for OCX. IMO has potential for massive gains in 2021.
Oncocyte Announces Definitive Agreement to Acquire Chronix Biomedical, Inc.
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.
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