Labcorp Announces Availability of First Companion Diagnostic Assay to Identify Gastric Cancer Patients Eligible for Targeted Treatment with VYLOY™
Labcorp's participation in Roche Day-One readiness program highlights ability to provide timely access to testing for patients with gastric and gastroesophageal junction cancers
BURLINGTON, N.C. (October 31, 2024) – Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced its readiness to begin providing the Roche VENTANA® CLDN18 (43-14A) RxDx Assay in the United States. The VENTANA CLDN18 (43-14A) RxDx Assay recently received U.S. Food and Drug Administration (FDA) approval for use in determining patients who may be eligible for treatment with VYLOY™ (zolbetuximab-clzb). VYLOY™ is the first and only targeted therapy approved for patients with advanced gastric or gastroesophageal junction (GEJ) cancers whose tumors are HER2-negative and Claudin 18.2-positive.
“Labcorp is committed to collaborating closely with biopharmaceutical and biotechnology partners, such as this effort with Astellas and Roche, that help provide physicians and patients with access to life-saving therapies,” said Dr. Jonathan Klein, divisional medical director of Labcorp Oncology. “Our ability to provide the new CLDN18 (43-14A) RxDx Assay immediately upon FDA approval underscores our dedication to expanding access to scientific breakthroughs in oncology to improve health and improve lives.”
The VENTANA CLDN18 (43-14A) RxDx Assay is the first and only FDA-approved immunohistochemistry (IHC) companion diagnostic for identifying patients with advanced gastric or GEJ cancer whose tumors express the Claudin 18 (CLDN18) protein (specifically the 18.2 isoform). CLDN18.2 is a biomarker in gastric and GEJ cancers that helps predict the likelihood of response to targeted therapies. Patients with gastric or GEJ cancer whose tumors express CLDN18.2 may be eligible for targeted first-line treatment with VYLOY™, a recently-approved monoclonal antibody that binds to CLDN18.2, triggering immune responses that inhibit tumor growth.
Gastric cancer remains a significant global health challenge, ranking among the leading causes of cancer-related deaths worldwide. Most patients are diagnosed in the advanced stages of the disease, which has a five-year survival rate of only 7%. VYLOY™ is the first and only FDA-approved monoclonal antibody for treating adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
Labcorp participated in the Roche Day-One readiness program and fulfilled all requirements of the extensive validation of test processes and operating protocols while CLDN18 (43-14A) was under regulatory review. The Day-One readiness program ensures Labcorp can begin processing patients’ tumor samples on the VENTANA CLDN18 (43-14A) RxDx Assay directly following FDA approval, providing timely access to oncologists and patients with gastric or GEJ cancers.
For more information about the assay and Labcorp Oncology diagnostic services, visit https://oncology.labcorp.com/tests/452390/claudin-18-ihc.
About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world. Learn more about us at www.labcorp.com.
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