Hematogenix introduces the FDA-approved immuno-oncological diagnostic adjunctive diagnostic test for triple-negative breast cancer

Thursday, March 14, 2019

Hematogenix®, a global leader in integrated pathology services for drug development and immuno-oncological testing, today announced the introduction of the companion diagnostic test for TECENTRIQ®. On March 8, 2019, the US Food and Drug Administration (FDA) approved the TECENTRIQ immunotherapy in combination with Abraxane as a first-line treatment for PD-L1-positive, non-resectable, locally advanced, or metastatic triple negative breast cancer (triple-negative breast cancer; TNBC). TECENTRIQ is the first immunotherapy approved for the treatment of breast cancer.

The FDA-approved companion diagnostic test for the selection of TNBC patients eligible for TECENTRIQ treatment is the VENTANA PD-L1 (SP142) assay. Hematogenix has extensive experience in performing PD-L1 assays for both the diagnostic and clinical trials. As the market leader in immuno-oncological testing, Hematogenix has been able to validate all commercial and FDA-approved PD-L1 assays since the beginning of 2016.

"We have always had broad commercial access to high quality PD-L1 testing. We continue to focus on implementing our mission of helping our physicians find the most appropriate treatment options for their patients, "said Hytham Al-Masri , MD, CEO and Founder of Hematogenix Advances in immunotherapy for patients with triple negative breast cancer provide additional options for patients suffering from this aggressive disease. " I am proud that my team is continuously dedicated to this groundbreaking area of ??cancer research. "

The VENTANA PD L1 (SP142) assay is an immunohistochemical analysis of programmed cell death ligand 1 (PD-L1) in tumor cells and tumor-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tumor tissue.

Information about Hematogenix
Hematogenix is ??a global biotechnology company providing reference laboratory services. His team includes accredited clinical, anatomy and research pathologists, and works with leading scientists from around the world to provide high-quality testing, consulting and guidance covering all aspects of the company's pharmaceutical and diagnostic business. Hematogenix offers a range of biomarker development activities as well as testing services that seek to overcome the complexity of clinical trials involving human subjects. The company's CAP and CLIA approved clinical laboratories are CAP compliant and serve as clinical and anatomical test providers as specialized clinical research organizations in both the pharmaceutical and oncology industries. Learn more about Hematogenix's comprehensive biomarker development and testing serviceswww.hematogenix.com .

HEMATOGENIX® is a registered trademark of Hematogenix Laboratory Services, LLC.
TECENTRIQ® is a registered trademark of Genentech, Inc.

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Contact Kathryn E. Evans
708-444-0444
kevans@hematogenix.com

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