FDA clears first quantitative nucleic acid assay for BCR-ABL

FDA Approved

Molecular Test to Guide CML Therapy OK’d

FDA clears first quantitative nucleic acid assay for BCR-ABL

A molecular diagnostic for measuring BCR-ABL levels in patients with chronic myeloid leukemia (CML) was cleared for marketing Friday, the FDA announced.
It’s the first quantitative nucleic acid assay for this purpose to be approved in the U.S., the agency said.

Manufactured by Asuragen of Austin, Texas, the QuantideX qPCR BCR-ABL IS assay will be distributed as a kit for use in properly equipped clinical labs. It works on blood specimens and helps clinicians gauge the effects when patients are treated with drugs targeting BCR-ABL.

The FDA cleared the test under its “de novo” classification pathway for novel devices considered to pose low to moderate risks to patients if they do not perform as intended.
In a study involving specimens from 98 CML patients, outcomes were better in patients whose test results showed reductions in BCR-ABL after targeted therapy, compared with patients not showing such reductions.
“This marketing authorization of a BCR-ABL test assists in the availability of consistent and understandable results for clinicians managing CML patients,” the agency said.

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