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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.

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

The five-year-old firm recently completed a clinical trial of the real-time PCR-based test, called ProALL-BM, on patients from a European National Registry Study.

JP Morgan healthcare conference opening

Among the diagnostic firms presenting at the conference on Tuesday were lab giant LabCorp, diversified medical products firm Hologic, and MDx startups, such as Adaptive Biotechnologies.

The researchers plan to profile patients with both Adaptive Biotechnologies' ImmunoSeq platform and 10x Genomics' single-cell immune repertoire profiling technology. 

The companies plan to codevelop Adaptive's ClonoSeq assay to measure minimal residual disease in ALL. 

The company is using its MIRA assay internally and in research collaborations to identify biomarkers that can serve as the basis for immunotherapies.