Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products

Solid organ transplantation is used to treat end-stage organ failure, including the kidneys

Bio-Rad Laboratories and Oncocyte Corporation have partnered to develop and commercialise solid tissue transplant monitoring products for researchers and laboratories to “advance science and save lives”.

The collaboration will utilise Bio-Rad’s Droplet Digital Polymerase Chain Reaction (ddPCR) technology.

Solid organ transplantation is a medical procedure to treat end-stage organ failure of the kidneys, liver, pancreas, heart and lung.

Currently the most commonly transplanted organ worldwide, kidney transplantation was performed more than 42,800 times in 2022, according to the United Network for Organ Sharing.

Under the terms of the agreement, Bio-Rad has agreed to participate in a private placement of Oncocyte’s equity and has secured exclusive commercial rights in certain markets to commercialise the precision diagnostics company’s assay for transplant monitoring research using the QX600 ddPCR system.

When organs are transplanted, cell-free DNA, otherwise known as donor-derived cell-free DNA (dd-cfDNA), a sensitive biomarker for organ health that requires a simple blood test, is released into the bloodstream of the patient.

The novel approach developed by Oncocyte will allow the assay to be applied to clinical research on recent and non-recent transplants.

Bio-Rad’s ddPCR-based systems have been demonstrated in a prospective, observational, multicentre cohort trial published in 2017, which showed earlier and more sensitive discrimination of liver transplant patients with acute rejection in comparison to conventional liver functional test methods.

Both Oncocyte’s transplant monitoring assay and Bio-Rad’s QX600 ddPCR systems aim to provide a highly sensitive and decentralised solution as a potential alternative approach for laboratories that currently rely on centralised next-generation sequencing test providers.

Simon May, executive vice president and president, life sciences, Bio-Rad, commented: “We believe that Oncocyte’s transplant monitoring assays and the Bio-Rad QX600 ddPCR system solution for the noninvasive measurement and quantification of key biomarkers used in solid tissue transplant monitoring research [have] the potential to advance science and save lives.”

Most recently, Bio-Rad partnered with Alleghany Health Network to advance clinical evidence for monitoring solid tumour cancer using Bio-Rad’s ddPCR technology.