TINLEY PARK, Ill., Aug. 5, 2016 /PRNewswire/ -- Hematogenix®, an industry leader in the field of integrated pathology services for drug development and immuno-oncology testing, announces the availability of the Ventana PD-L1 (SP142) and the PD-L1 (SP263) assays.
In May 2016, the Ventana PD-L1 (SP142) assay was approved by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients with metastatic urothelial cancer (mUC) who are considering treatment with the FDA approved Roche immunotherapy TECENTRIQ™ (atezolizumab). The Ventana PD-L1 (SP263) is indicated as an aid in the assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) and other tumor types.
"With the addition of these new PD-L1 assays SP142 and SP263, Hematogenix continues to lead the way in immuno-oncology testing," said Hytham Al-Masri, M.D., CEO and Medical Director of Hematogenix. "Our comprehensive PD-L1 offering has been expanded to include all four commercially available clones offered by Dako and Ventana. We feel by providing broad access to high quality PD-L1 testing, we will continue to help our physicians identify the most appropriate treatment options for their patients."
In April of this year, Hematogenix announced the availability of the FDA-approved PD-L1 companion diagnostic assays: PD-L1 IHC 22C3 pharmDx for KEYTRUDA®, Merck's Anti-PD-1 therapy for metastatic non-small cell lung cancer, and PD-L1 IHC 28-8 pharmDx, a complementary diagnostic assay to support Bristol-Myers Squibb's OPDIVO® anti-PD-1 therapy for non-squamous non-small cell lung cancer and melanoma.
Hematogenix is a CAP/CLIA-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 logistics 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 complies with rigorous chain-of-custody and specimen-management practices.
Kathryn E. Evans
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