FDA expands use of Qiagen lung cancer mutation test

2017 09 14 23 05 1167 Cancer Cell 400

The U.S. Food and Drug Administration (FDA) approved the expanded use of a Qiagen diagnostic kit as a companion test for the identification of non-small cell lung cancer patients who may be eligible for treatment with a newly approved drug.

Qiagen's polymerase chain reaction (PCR) test, the Therascreen KRAS RGQ PCR kit, is a tissue-based test that identifies the KAS KRAS G12C mutation in non-small cell lung cancer; the FDA approved the test for expanded use with Amgen's sotorasib (Lumakras). KRAS is one of the most frequently occurring mutations in this type of cancer.

The kit, which will be via Qiagen's Day One Lab Readiness program, is used with the Rotor-Gene Q MDx instrument.

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