Oncocyte Begins Manufacturing Transplant Blood Test
Over 1 million annual testing opportunities in US
Q4 targeted for early access launch
IRVINE, Calif., June 27, 2023 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced that it has begun the manufacturing process for the distributable version of its patented transplant technology. A method of checking for signs of graft damage in transplant recipients, the assay measures levels of donor derived cell-free DNA (dd-cfDNA) in the blood. Early access for this RUO kit is expected to open in late Q4 2023.
“We believe that our patented method of assessing graft damage offers distinct benefits over competing and more invasive approaches,” said Josh Riggs, Oncocyte’s CEO. “Oncocyte is committed to being a partner for the transplant community. Our test provides a simple, easy-to-use workflow, on droplet digital PCR, so researchers can perform in-house dd-cfDNA testing. We believe opening access to our technology supports broader research than what is addressable with today’s centralized testing. We look forward to updating investors on rapid manufacturing progress as we move to commercialization.”
The test can typically be accomplished within the same day, without the necessity of donor genotyping. Results will be provided in both percentage and precise quantification of dd-cfDNA.
About Oncocyte
Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and pipeline test DetermaCNI™ is a blood-based monitoring tool for assessing therapeutic efficacy in cancer patients.
VitaGraft™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.
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, among other things, the expectation that Oncocyte technology will be available for early access in late Q4, and 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 Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential 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 (SEC) 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
Jesse Arno
(949) 409-6770
jarno@oncocyte.com
