Clinical diagnostics developer Adaptive Biotechnologies has obtained the US Food and Drug Administration (FDA) de novo designation for the clonoSEQ Assay in multiple myeloma (MM) and B-cell acute lymphoblastic leukaemia (ALL) patients.
The designation covers the use of the assay to detect and monitor minimal residual disease (MRD), which refers to a small number of cancer cells that can remain after treatment, using a bone marrow sample.
The clonoSEQ Assay leverages multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) technology to evaluate the disease burden. It is said to be the first FDA-cleared assay for MRD assessment in any lymphoid cancer.
MRD may not cause signs or symptoms but can result in disease recurrence, and even very low levels are known to affect treatment success and patient outcomes.
A test to identify the presence and amount of residual disease at very low levels, in combination with other factors that predict treatment outcomes, is expected to help in disease management decisions.
Adaptive Biotechnologies CEO and co-founder Chad Robins said: “The clearance of the clonoSEQ Assay is an exciting advance for MM and ALL patients and physicians; as MRD is increasingly used to inform treatment decisions, the importance of having an accurate and standardised assessment method becomes paramount.”
In the US, more than 200,000 people are currently living with MM or ALL, and more than 35,000 new cases are diagnosed annually.
The clonoSEQ Assay is said to accurately identify and track MRD in these patients throughout treatment and remission. The test is said to feature greater sensitivity compared to other relevant technologies.
FDA commissioner Scott Gottlieb said: “Determining whether a patient has residual cancer cells remaining after treatment provides information on how well a patient has responded to therapy and how long remission may last.
“Having a highly sensitive test available to measure minimal residual disease in ALL or multiple myeloma patients can help providers manage their patients’ care.”