Oncocyte Corporation, a company specializing in precision diagnostics, has announced a partnership with Bio-Rad Laboratories (NYSE: BIO), a prominent player in life science research and clinical diagnostics. The collaboration aims to commercialize Oncocyte's research-only GraftAssure™ assay, which utilizes Droplet Digital™ PCR (ddPCR™) technology. The product is set to launch in the second quarter of 2024, initially targeting academic transplant centers in the US and EU, with plans for broader distribution later in the year.

Under the agreement, Bio-Rad and Oncocyte will jointly market the assay in the US and Germany, with Oncocyte taking the lead in commercial activities. Outside of these regions, Bio-Rad has secured exclusive global distribution and commercialization rights.

Josh Riggs, CEO of Oncocyte, expressed confidence in the partnership, stating, “Having the support of the Bio-Rad team in the US and Germany as we approach launch provides the scalability necessary to capitalize on the market opportunity.” He highlighted Bio-Rad's QX600 ddPCR platform and their expertise in the life science sector as key factors driving the collaboration.

Moving forward, both companies are committed to collaborative efforts aimed at developing a regulated product to facilitate widespread distribution and clinical adoption, initially targeting the United States and beyond.

In addition to the collaboration, Bio-Rad has been granted an option for in vitro diagnostic (IVD) commercial rights upon FDA clearance, contingent on meeting specific milestones. The exercise of this option would involve a second equity investment in Oncocyte. Further details of the agreement are available in Oncocyte’s filing with the Securities and Exchange Commission.

DD-CFDNA, a proven non-invasive biomarker in high demand, presents an estimated three million testing opportunities globally and drives a market exceeding $1 billion. With over 157,000 transplants performed annually worldwide and a growth rate of 9.1%, there is significant potential for GraftAssure™, which utilizes Droplet Digital PCR technology to quantify dd-cfDNA and detect indications of graft damage.

 

Source: globenewswire.com

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