Labcorp, Qiagen Therascreen KRAS PCR Mutation Analysis
Laboratory Corporation of America has launched Qiagen's Therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer who are eligible for treatment with sotorasib (Amgen's Lumakras). The drug and the test were approved by the US Food and Drug Administration in late May. The assay uses a liquid biopsy specimen to identify patients with a specific mutation in the KRAS gene called KRAS G12C and who have received at least one prior systemic therapy. Citing statistics from the American Cancer Society, Labcorp said between 10 and 12 percent of the 228,000 people diagnosed with lung cancer carry the mutation. In 2019, Qiagen joined Labcorp's Day-One lab readiness program to expedite patient access to Qiagen's CDx products following regulatory approval of the tests and associated drugs.