On July 1, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported 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 (Press release, LabCorp, JUL 1, 2021, View Source [SID1234584545]).

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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 U.S. 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 (NYSE: QGEN, Frankfurt Stock Exchange: QIA) 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 (NASDAQ: AMGN). 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.

"We have a longstanding relationship with Labcorp and are delighted to collaborate with them again to bring this new companion diagnostic indication to NSCLC patients," said Jonathan Arnold, vice president, Oncology and Partnering for Precision Diagnostics at QIAGEN. "The expanded indication on our QIAGEN therascreen KRAS test will provide clinically relevant information to aid physicians in identifying patients eligible for a new class of treatment in NSCLC."

During the last 25 years, Labcorp has played a significant role in launching hallmark testing options for the treatment of cancer. The company remains committed to further developing companion diagnostics and precision medicines. This new offering adds to its growing portfolio of tests that specialize in more personalized care, leading to more specific treatment choices. In addition to single marker tests, Labcorp offers full panels of testing powered by advanced next generation-sequencing (NGS) technology for complete profiling of a patient’s unique tumor, including mutations in KRAS.

For more information about Labcorp’s full menu of companion and complementary diagnostic tests, visit oncology.labcorp.com.

LUMAKRAS is a trademark of Amgen, Inc.

therascreen is a registered trademark of QIAGEN.