Full Press Release Details
and Bio-Rad Partner on Global Launch of Transplant Assay
Bio-Rad expects to make equity investment in support of deal
- Agreement provides for global exclusivity in transplant monitoring commercialization
- Bio-Rad granted subsequent investment option upon FDA clearance
Calif., April 11, 2024 (GLOBE NEWSWIRE) - Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced
a partnership agreement with Bio-Rad Laboratories (NYSE:BIO), a global leader in life science research and clinical diagnostics products,
for the commercialization of its research use only GraftAssure assay, powered by Droplet Digital PCR (ddPCR )*.
The new product is expected to launch in Q2 2024 to a select group of academic transplant centers in the US and EU and more broadly
in the second half of the year.
part of the agreement, Bio-Rad and Oncocyte will co-market the assay inside the US and Germany, with Oncocyte acting as commercial lead.
Outside these countries Bio-Rad has been granted exclusive global distribution and commercial rights.
we move towards launch, having the support of the Bio-Rad team in the US and Germany gives us the scale we need to meet the market opportunity,"
said Josh Riggs, Oncocyte's CEO. "The QX600 ddPCR platform, along with their expertise in serving the life science
market, makes Bio-Rad a natural partner for our transplant technology."
forward, both companies have committed to joint efforts in developing a regulated product designed
to facilitate widespread distribution and clinical adoption in the United States and beyond.
Bio-Rad has been granted an option for IVD commercial
rights at FDA clearance, subject to meeting specific objectives. Exercising the
option would come with a second equity investment into Oncocyte. Further details of the agreement
can be found in Oncocyte's filing with the Securities and Exchange Commission.
is a proven, non-invasive biomarker with growing demand offering an estimated three million testing opportunities globally and driving
a market exceeding $1 billion. Globally, over 157,000 transplants are performed with a 9.1% annual
growth rate. GraftAssureTM uses a differentiated technology, Droplet Digital
PCR to quantify dd-cfDNA to detect signs of graft damage.
Digital, ddPCR and QX600 are trademarks of Bio-Rad Laboratories, Inc.
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 clinical blood-based solid organ transplantation monitoring test, which recently received CMS reimbursement
for kidney transplantation. GraftAssure is a decentralized research use only blood-based solid organ transplantation monitoring
test, DetermaIO is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and
the pipeline test DetermaCNI is blood-based monitoring tool for assessing therapeutic efficacy.
GraftAssure , DetermaIO , and DetermaCNI are trademarks of Oncocyte Corporation.
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 expected launch of the new GraftAssure
product in 2Q 2024 to a select group of academic transplant centers in the US and EU and more broadly in the second half of the year,
the transactions contemplated by the Collaboration Agreement, the expectation of meeting the market opportunity, the anticipated development
of a regulated product and system designed to facilitate widespread distribution and clinical adoption of the core technology in the
United States and beyond, the expectation for FDA clearance, the possibility that Bio-Rad will exercise its option for IVD commercial
rights and with a second equity investment, , 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, 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.