On October 2, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of a new FDA-approved companion diagnostic, the PD-L1 IHC 22C3 pharmDx assay by Dako, an Agilent Technologies company, to assess the eligibility of non-small cell lung cancer (NSCLC) patients for treatment with pembrolizumab (Keytruda) (Press release, LabCorp, OCT 2, 2015, View Source;p=RssLanding&cat=news&id=2092774 [SID:1234507639]).
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"This significant launch powerfully demonstrates the importance of the LabCorp-Covance combination," said David P. King, Chairman and Chief Executive Officer. "Our central laboratory was exclusively responsible for testing specimens for PD-L1 expression in the KEYNOTE-001 registration trial, and LabCorp is one of the first laboratory providers of the PD-L1 IHC 22C3 pharmDx test. We continue to focus on our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic results."
"Importantly, LabCorp’s involvement with the KEYNOTE-001 registration trial gives us experience that no other lab has in performing and interpreting the results of this assay in a standardized manner," stated Dr. Steve Anderson, Chief Scientific Officer of Covance Drug Development. "The availability of this test reflects how our combined capabilities will support improved patient outcomes and reduced healthcare costs by delivering world class diagnostics and bringing innovative new medicines to patients."
"LabCorp’s best-in-class companion diagnostic capabilities supported the approval of Keytruda and its companion diagnostic," stated Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer. "The PD-L1 IHC 22C3 pharmDx assay is an important advance in personalized medicine that enables clinicians to determine whether a patient with metastatic NSCLC is a candidate for this new immuno-oncology therapy. The launch of this innovative test is another example of our unique ability to support development and commercialization of new companion diagnostics, helping to advance treatment options for cancer and other diseases."
"We are very pleased with LabCorp’s efforts to bring this important new test to patients with metastatic non-small cell lung cancer. As the central testing laboratory for the registration trial, LabCorp supported the development of the therapeutic and companion diagnostic applications for Keytruda, and will now make this approved test for the PD-L1 biomarker available to physicians and patients across the country," said Dr. Eric Rubin, vice president, Merck Research Laboratories.
According to the American Cancer Society, lung cancer is the leading cause of cancer death in the U.S. and is the second most commonly diagnosed cancer with an estimated 221,200 new cases diagnosed in 2015. The vast majority of patients exhibit the non-small cell subtype, representing 80-85% of patients, and over half of these patients are diagnosed with metastatic or advanced disease at initial presentation. Data from the KEYNOTE trial recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and published in the New England Journal of Medicine demonstrated that PD-L1 expression in at least 50% of non-small cell lung tumor cells correlated with improved response rates and progression free survival in patients treated with Keytruda.
For more information on the PD-L1 pharmDx test, contact the Integrated Oncology customer service line at (800) 447-5816.