QIAGEN Launches First FDA-approved Tissue Companion Diagnostic to Identify the KRAS G12C Mutation in NSCLC Tumours and Expand Precision Medicine Options in Lung Cancer
Qiagen N.V. Common Shares (QGEN)
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Source: Business Wire
The therascreen® KRAS RGQ PCR Kit receives U.S. regulatory approval from FDA for expanded scope to include use in guiding treatment with the newly approved therapy LUMAKRASTM (sotorasib) from AmgenFirst tissue-based companion diagnostic to identify the KRAS G12C mutation in NSCLCTest will be available under QIAGEN’s Day One Lab Readiness program GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of an expanded scope of companion diagnostic (CDx) claims for the therascreen® KRAS RGQ PCR Kit (therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN).The therascreen KRAS Kit is the first companion diagnostic test to obtain premarket approval from the U.S. Food and
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