In October 2016, the FDA approved KEYTRUDA, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.
This is the first FDA approval of a checkpoint inhibitor for first-line treatment of lung cancer. This approval also expands the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC.
Hematogenix continues to support Merck's newest indications by reporting PD-L1 results consistent with the new FDA guidelines which include:
- No PD-L1 Expression (Tumor Proportion Score) [TPS] less than 1%)
- Expression (TPS greater than or equal to 1%)
- High PD-L1 Expression (TPS greater than or equal to 50%).
"By providing broad access to high quality PD-L1 testing, we will continue to help our oncology doctors identify the most appropriate treatment options for their patients." Hytham Al-Masri, MD, Medical Director/CEO goes on to state, "we support our pharma clients globally by offering these assays in both our US and European locations." Hematogenix announced in December 2016 that its Alderley Park, UK facility was awarded College of American Pathologists (CAP) accreditation.
Hematogenix a CAP/CLIA-certified laboratory with board-certified clinical, anatomic and research pathologists who provide consultation and guidance for all aspects of the company's pharma and diagnostic services. Hematogenix offers an array of biomarker development and testing services which navigate the complexities of human subject clinical trials. Hematogenix provides logistics management of sample procurement, distributes collection kits, and contributes to standards and procedures required for initiating a clinical trial. Learn more about Hematogenix's comprehensive biomarker development and testing services at www.hematogenix.com.
Hematogenix® is a registered trademark of Hematogenix Laboratory Services, LLC.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Kathryn Evans, 708-444-0444
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SOURCE Hematogenix Laboratory Services, LLC