Labcorp, a leading global life sciences company, announced the availability of therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with Lumakras (sotorasib), a new treatment option developed by Amgen.

Labcorp’s oncology platform brings together the company’s leadership in diagnostic testing with its comprehensive drug development services, helping to pioneer scientific breakthroughs like the KRAS companion diagnostic to identify patients eligible for cutting-edge targeted therapies.

“Every day, cancer patients across the country anxiously await test results that directly impact treatment decisions. Through our collaboration with Qiagen and participation in their Day-One Lab Readiness Program, Labcorp is committed to ensuring critical biomarker testing for KRAS is immediately accessible to physicians to ensure every patient who may benefit from sotorasib is appropriately identified and treated,” said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp, and a triple-board certified hematology and oncology physician. “Labcorp is proud to be one of the first labs to make the therascreen KRAS test available, in addition to the many other diagnostic tests in our testing portfolio, including companion diagnostics that have been made available soon after FDA approval for breast, lung, colorectal, bladder and other cancers.”

The therapy and this indicated use of the test as a companion diagnostic received approval from the US Food and Drug Administration (FDA) in late May 2021. The therascreen KRAS PCR Mutation Analysis is now available for ordering from Labcorp to determine if patients carry a specific mutation in the KRAS gene.

Qiagen developed the assay, and Labcorp applied its scientific validation process to be able to offer the assay through its CAP accredited, CLIA-certified specialty labs. Using the lung biopsy specimen, the assay identifies whether a patient with NSCLC has a specific mutation in the KRAS gene and is eligible for treatment with Lumakras (sotorasib) which was developed by Amgen. This is the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with NSCLC whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. KRAS mutations have been found to enable cells in certain cancers to grow and spread more easily.

According to the American Cancer Society, in 2020, 10-12% of the 228,000 people diagnosed with lung cancer carry the G12C KRAS mutation. Lung cancer is still one of the most common cancers worldwide. Approximately 84% of lung cancers are NSCLC.