Oncocyte and Bio-Rad Partner on Global Launch of Transplant Assay
Oncocyte (OCX) announces a partnership with Bio-Rad Laboratories (BIO) for the commercialization of GraftAssure™ assay, powered by Droplet Digital PCR. The agreement grants Bio-Rad global exclusivity in transplant monitoring commercialization, with an equity investment option upon FDA clearance. The new product is set to launch in Q2 2024 in the US and EU.
Examining the partnership between Oncocyte Corporation and Bio-Rad Laboratories reveals a strategic move to capitalize on the growing transplant diagnostics market. The collaboration leverages Bio-Rad's established global distribution network and technical expertise in Droplet Digital PCR, a highly sensitive and quantitative DNA analysis technique. This partnership is poised to enhance the commercial prospects of the GraftAssure™ assay, particularly given the exclusivity granted to Bio-Rad for global commercial rights outside the US and Germany.
With over 157,000 transplants occurring annually and a market growth rate of 9.1%, the potential market for non-invasive biomarker testing, such as dd-cfDNA, is significant. The assay's targeted launch to academic transplant centers positions it within a niche yet critical segment that could serve as a springboard for broader clinical adoption. The phased launch strategy, with a broader release in the second half of 2024, suggests a calculated approach to market penetration and scaling up production.
However, the true inflection point for the assay's market impact hinges on FDA clearance. The option for IVD commercial rights upon FDA approval could be a catalyst for substantial revenue growth for Oncocyte, with Bio-Rad's subsequent equity investment reinforcing the financial stability and collaborative commitment of both entities. The market will be watching closely for the FDA's decision, as it will significantly influence the commercial trajectory of the GraftAssure™ assay.
From a financial perspective, the partnership agreement between Oncocyte and Bio-Rad is a strategic initiative that could generate substantial value for both companies. Bio-Rad's equity investment, contingent upon FDA clearance, not only provides Oncocyte with capital infusion but also signifies confidence in the product's commercial viability. The exclusivity aspect of the deal ensures that Bio-Rad has a vested interest in maximizing the assay's market penetration, which could lead to substantial revenue growth for Oncocyte, given the sizable market opportunity estimated at over $1 billion.
Investors should note the potential for increased operational expenses as the companies ramp up for the launch and commercialization efforts. However, the co-marketing strategy in the US and Germany could mitigate some of these costs by leveraging Bio-Rad's existing resources. The deal's structure, with staged investments and commercial rights tied to regulatory milestones, reduces upfront risk for Bio-Rad while providing Oncocyte with the financial and operational support needed for market entry.
It is important to monitor Oncocyte's SEC filings for further details on the financial terms, as they will provide greater insight into the deal's structure and the potential impact on the company's balance sheet. Investors should also consider the competitive landscape and the adoption rate of non-invasive testing in transplant monitoring to assess the long-term revenue potential of the GraftAssure™ assay.
04/11/2024 - 05:30 PM
- Bio-Rad expects to make equity investment in support of deal
IRVINE, 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.
As 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.
“As 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.”
Going 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.
Additionally, 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.
dd-cfDNA 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. GraftAssure™ uses a differentiated technology, Droplet Digital PCR to quantify dd-cfDNA to detect signs of graft damage.
*Droplet Digital, ddPCR and QX600 are trademarks of Bio-Rad Laboratories, Inc.
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 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.
VitaGraft™, GraftAssure™, 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 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.
CONTACT:jramson@pcgadvisory.com
What is the partnership agreement between Oncocyte and Bio-Rad Laboratories about?
The partnership agreement is for the commercialization of GraftAssure™ assay, powered by Droplet Digital PCR, granting Bio-Rad global exclusivity in transplant monitoring commercialization.
When is the new product expected to launch?
The new product is expected to launch in Q2 2024 to a select group of academic transplant centers in the US and EU, with broader availability in the second half of the year.
What technology does GraftAssure™ assay use?
GraftAssure™ assay uses Droplet Digital PCR technology to quantify dd-cfDNA and detect signs of graft damage.
What are the estimated testing opportunities for dd-cfDNA globally?
dd-cfDNA offers an estimated three million testing opportunities globally, driving a market exceeding $1 billion.
How many transplants are performed globally annually?
Globally, over 157,000 transplants are performed annually with a 9.1% growth rate.
