FDA clears first quantitative nucleic acid assay for BCR-ABL
- September 16, 2016
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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.
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.