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Adaptive Bio Receives NY State Approval for ClonoSeq in B Cell Cancers

NEW YORK – Adaptive Biotechnologies announced that its ClonoSeq assay is now available in all 50 states, following approval from the New York State Department of Health clinical laboratory evaluation program (CLEP), the firm said in a statement.

The assay received approval from NY State for detection and monitoring of minimal residual disease in patients with B cell blood cancers.

"New York State CLEP approval for ClonoSeq means patients in New York can now work with their cancer care team to incorporate ClonoSeq into their treatment regimen to accurately and reliably assess and monitor their disease over time, using multiple sample types, including blood samples," Adaptive CEO and Cofounder Chad Robins said in a statement. "This rigorous approval also supports our ongoing work to expand access to patients and our pursuit of FDA authorization for new indications for ClonoSeq in other lymphoid cancers and sample types."

B cell cancers are a subset of lymphoid cancers that includes acute lymphoblastic leukemia, multiple myeloma, chronic lymphocytic leukemia, and B cell non-Hodgkin's lymphoma.

The US Food and Drug Administration granted ClonoSeq de novo premarket authorization in October 2018. According to the Seattle-based firm, it is the first clinical diagnostic powered by immunosequencing. It is a single-site assay performed on bone marrow samples at Adaptive but is also available as a CLIA-regulated laboratory developed test service for use in other lymphoid cancers.

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