FDA Approves New Test for Detecting Acute Lymphoblastic Leukemia or MM

By David Costill
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The FDA approved a new test for detecting low levels of cancer cells remaining in patients treated for acute lymphoblastic leukemia (ALL) or multiple myeloma (MM), according to a press release.

“At the FDA, we’re continuing to maximize opportunities for innovation that can improve patient outcomes,” Scott Gottlieb, MD, commissioner of the FDA, said in the press release. “[This] approval is an important step forward for patients suffering from ALL and multiple myeloma. 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.”

Lab Test. Source.

The new test is a next generation, sequencing-based test that measures minimal residual disease (MRD), which can determine if low levels of disease remain in patients who have been treated for MM or ALL. This will allow physicians to detect cancer in patients who have responded to treatment but have levels of disease that are too low to be measured by standard testing.

The in vitro diagnostic test examines DNA extracted from bone marrow for certain gene sequencing using flow cytometry assays or polymerase chain reaction. The new test is called the ClonoSEQ.

The FDA said it is currently working to approve more tests that can detect cancer cells in a similar manner.

“The FDA is applying novel regulatory approaches to make sure that these rapidly evolving NGS tests are accurate and reliable,” Gottlieb said. "At the same time, we’re seeing more and more laboratory-developed tests seek marketing authorization from the FDA. We’re doing as much as we can to advance these opportunities for patients under our current authorities. But we believe that to more fully unlock these innovations, we need to modernize the regulatory framework for all in vitro clinical tests We believe such an approach can promote the development of safe, effective technologies that have the greatest potential to help us diagnose, treat and cure disease.”