Adaptive Biotechnologies, Seattle, has formed a partnership with Illumina, San Diego, to develop in vitro diagnostic (IVD) test kits for Adaptive’s current and future portfolio of next-generation sequencing (NGS)-based immunodiagnostics.
The test kits under development will expand the availability of two Adaptive assays: ClonoSEQ, for assessing and monitoring minimal residual disease (MRD) in the management of patients with certain blood cancers, and ImmunoSEQ Dx for immune profiling applications. Clinicians currently order ClonoSEQ as a test performed at Adaptive’s lab in Seattle. The planned IVD test kits will make it possible for hospitals and health systems to run Adaptive’s ClonoSEQ and ImmunoSEQ Dx assays in their local laboratories across the United States.

“We are proud to partner with Illumina to deliver on our promise to develop distributable kits for our novel immunodiagnostics to reach more patients,” says Chad Robins, CEO and cofounder of Adaptive Biotechnologies. “These IVD test kits will further validate Adaptive as a valued partner for standardized MRD monitoring and immune profiling solutions from research to the clinic.”

Under the nonexclusive agreement, Adaptive will develop the ClonoSEQ and ImmunoSEQ Dx IVD test kits to run on Illumina’s NextSeq 550Dx system. Adaptive will be responsible for obtaining necessary regulatory approvals for each IVD test kit and for their subsequent commercialization.

“By making Adaptive’s ClonoSEQ more accessible to patients, we are ensuring healthcare providers have access to a valuable part of a growing genomics ecosystem,” says Phil Febbo, MD, CMO at Illumina. “Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics. We are committed to unlocking the power of the genome through our work with Adaptive, which will expand access to genomic-based testing in order to improve patient outcomes.”

For further information, visit Adaptive Biotechnologies.