Adaptive Biotechnologies

Following FDA approval last October, Adaptive has now secured Medicare coverage for its NGS-based minimal residual disease assay, ClonoSeq.

The company is also looking to expand the use of its FDA-approved ClonoSeq assay, which has US FDA approval for MRD detection in acute lymphocytic leukemia and multiple myeloma.

Adaptive will use its T-cell receptor screening platform to identify TCRs that can be used to target individual cancer patients' neoantigens.

Researchers will use Adaptive's immune repertoire sequencing technology to look for a molecular signature of type 1 diabetes.

In granting de novo premarket authorization to ClonoSeq, the agency established its regulatory expectations for similar tests.

The firms will use Adaptive's ClonoSeq assay to assess minimal residual disease in multiple myeloma patients treated with Sanofi's isatuximab.

The companies are planning to develop individual disease diagnostics, and then a universal diagnostic from a single blood test.