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

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.