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Hematogenix® Laboratory Services (Hematogenix®), a leader in the field of integrated pathology services for drug development and clinical testing, announced on February 29th the availability of the U.S. Food and Drug Administration (FDA) approved companion diagnostic assays, PD-L1 IHC 22C3 pharmDx and PD-L1 IHC 28-8 pharmDx. Both kits are available through Dako, an Agilent Technologies company.
Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co., Inc., maker of the anti-PD-1 therapy KEYTRUDA® (pembrolizumab). KEYTRUDA is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy.
PD-L1 IHC 28-8 pharmDx, also by Dako, was approved as a complementary diagnostic to detect PD-L1 protein expression levels and to help physicians determine which patients may benefit most from treatment with Bristol-Myers Squibb's OPDIVO® (nivolumab). OPDIVO® has extended indication, from melanoma and non-small cell lung cancer to renal cell cancer.
"The immuno-oncology agents Keytruda and Opdivo have already transformed the cancer care landscape," said Hytham Al-Masri, M.D., CEO and Medical Director of Hematogenix®. "The addition of these two tests to our already existing menu of PD-L1 assays helps to identify patients who may benefit from immunotherapy. With the availability of new companion diagnostics, we continue to see how immune therapies can benefit patients across a wide range of tumors."
Hematogenix® is a CAP, CLIA (Clinical Laboratory Improvement Amendments) certified laboratory with a full complement of board certified clinical, anatomic and research pathologists to provide consultation and guidance for all aspects of their pharma and diagnostic services. The company offers a comprehensive array of biomarker development and testing services designed to navigate the complexities of human subject clinical trials. Hematogenix® provides logistic management of tissue and sample procurement, distributes collection kits and contributes to standards and procedures required for initiating a clinical trial. Powered by a state‐of‐the‐art laboratory information system, Hematogenix® facilities and practices comply with rigorous chain of custody and specimen management practices. Learn more about Hematogenix® biomarker and diagnostic services at www.hematogenix.com.