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Adaptive Biotechnologies Receives Expanded FDA Clearance for ClonoSeq MRD Assay

NEW YORK – Adaptive Biotechnologies announced Thursday that it has received expanded clearance from the US Food and Drug Administration for its clonoSeq assay to assess minimal residual disease (MRD) in patients with chronic lymphocytic leukemia (CLL.)

The next-generation sequencing-based test can now be used to detect and monitor MRD from blood or bone marrow samples and is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL, the firm said in a statement.

"FDA clearance of clonoSeq, which can detect one single cancer cell among a million healthy cells, is an important milestone for the CLL community," Brian Koffman, chief medical officer and executive VP of the CLL Society, said in a statement. "Looking with greater accuracy for persistent cancer cells can show how well treatment is working and may help inform important decisions such as changing or stopping therapy."

The clonoSeq test had previously been granted the de novo authorization for detection and monitoring of MRD in bone marrow in multiple myeloma and B cell acute lymphoblastic leukemia.

Adaptive also noted that it has launched a service that will enable clonoSeq patients to safely obtain blood draws in settings other than a hospital or clinic, due to COVID-19 concerns.

The assay is already covered by Medicare for use in MRD testing in CLL.