FDA has recently granted premarket notification (510(k)) clearance of the first nucleic acid-based quantitation test for use during treatment of patients with chronic myeloid leukemia (CML).
The agency reviewed data for the QuantideX qPCR BCR-ABL IS kit, manufactured by Asuragen Inc, Austin, Texas, 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. The disease arises from 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 in the United States will be diagnosed with CML in 2016.
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.
Clinical performance of the QuantideX qPCR BCR-ABL IS kit was evaluated by a study across three US clinical laboratories using banked samples from 98 patients. Study results demonstrated a significant difference in the outcomes of patients whose targeted therapies achieved reduced levels of BCR-ABL, compared with the outcomes of patients whose BCR-ABL levels remained high.
BCR-ABL testing is a critical tool to help clinicians determine whether patients are responding to treatment for CML. The agency’s marketing authorization for the BCR-ABL test will assist in making available consistent and understandable results for clinicians managing CML patients.