FDA allows marketing for first nucleic acid-based quantitation test for use during treatment of rare Leukemia

On July 22, 2016, the U.S. Food and Drug Administration (FDA) allowed marketing of the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients.  The FDA reviewed data for the QuantideX qPCR BCR-ABL IS Kit, manufactured by Asuragen, Inc., through the de novo classification process, a pathway to classify medical devices of low- to moderate-risk that are novel and not substantially equivalent to any legally marketed device.

CML is a rare disease that causes the body to make too many white blood cells, due to a genetic abnormality that produces the BCR-ABL gene (also known as the Philadelphia Chromosome) not found in normal cells.  CML mostly affects older adults and is rarely seen in children. According to the National Cancer Institute, approximately 8,000 people will be diagnosed with CML in 2016 in the U.S.

The QuantideX qPCR BCR-ABL IS Kit uses blood specimens from patients with CML to measure the amount of BCR-ABL, which can be used to estimate the amount of leukemia cells in a patient when treated with BCR-ABL targeted therapies.

The clinical performance of the QuantideX qPCR BCR-ABL IS Kit was evaluated by a study using banked samples across three U.S. clinical laboratories from 98 patients. Study results demonstrated a significant difference in the outcomes of patients who achieved reduced levels of BCR-ABL from targeted therapy from those who did not.

BCR-ABL testing is a critical tool to help clinicians determine whether patients are responding to treatment for CML. This marketing authorization of a BCR-ABL test assists in the availability of consistent and understandable results for clinicians managing CML patients.

For more information:

• NIH Statistics on Chronic Myeloid Leukemia
• Evaluation of Automatic Class III Designation (De Novo) Summaries

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health