Oncocyte Partners with Bio-Rad to Commercialize Solid Organ Transplantation Monitoring Test

Precision diagnostics company, Oncocyte Corporation (Nasdaq: OCX), has entered a strategic partnership with Bio-Rad Laboratories (NYSE: BIO), for the commercialization of its GraftAssure™ assay,

a blood-based solid organ transplantation monitoring test powered by Droplet Digital™ PCR (ddPCR™). The new Research Use Only product is designed to detect signs of graft damage and is expected to launch to select academic transplant centers in the US and EU in the second quarter of 2024, and more broadly in the second half of the year.

Globally, over 157,000 transplants are performed each year with a 9.1% annual growth rate. Oncocyte is pursuing an estimated market of more than three million testing opportunities globally, valued at over $1 billion.

Commenting on the collaboration, Josh Riggs, Oncocyte’s CEO, said, “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. The QX600 ddPCR platform, along with their expertise in serving the life science market, makes Bio-Rad a natural partner for our transplant technology.”

Bio-Rad Laboratories is a global leader in life science research and clinical diagnostics products.

Deal Highlights

  • Under the terms of the agreement, Bio-Rad and Oncocyte will co-market the GraftAssure™ assay in the US and Germany, where Oncocyte will act as commercial lead.
  • Bio-Rad has been granted exclusive global distribution and commercial rights outside the US and Germany.
  • Both companies have committed to the development of 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 in vitro diagnostic (IVD) commercial rights when FDA clearance is achieved, subject to meeting specific objectives. Exercising the option would come with a second equity investment into Oncocyte.

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.



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Oncocyte Partners with Bio-Rad to Commercialize Solid Organ Transplantation Monitoring Test

Catie Corcoran

Biotech Editor