Announcement: BioNTech Diagnostics GmbH and Metropolis Healthcare Ltd. announce partnership to commercialize new breast cancer stratification test

  • Strategic partnership to make BioNTech´s mRNA-based molecular breast cancer
  • stratification test, MammaTyper®, commercially available in India, Sri Lanka, Kenya, Mauritius, Ghana and Zambia through Metropolis’ medical testing service laboratories
  • Partners combine their expertise in in vitro diagnostics and clinical testing services to enable
  • precise characterization of breast cancer tumor types

 Mainz, Germany and Mumbai, India, August 9th, 2017 – BioNTech Diagnostics GmbH, a fullyowned subsidiary of BioNTech AG, a company pioneering individualized cancer immunotherapy and diagnostics, and Metropolis Healthcare Ltd., India’s leading chain of pathology labs and diagnostics centers announced today their strategic partnership to offer breast cancer stratification testing in India, Sri Lanka, Kenya, Mauritius, Ghana and Zambia. Metropolis will provide access to BioNTech’s MammaTyper® test through its laboratory testing services. With a population of more than one billion people and 144,000 newly detected breast cancer cases per year, India is in dire need of  innovative diagnostic tests that improve treatment outcomes.

“We are very pleased to enter this partnership with Metropolis, one of the most respected medical testing labs in India, allowing access to MammaTyper® in one of the largest regions in the world,” said Dr. Sierk Poetting, Managing Director BioNTech Diagnostics GmbH. “With its onco-pathological expertise and strong presence in six countries, Metropolis is well suited to help address the significant patient need that exists while also enabling market reach to inform continued growth.”

“This alliance reinforces Metropolis’ strategy to offer innovative tests, which combine proven medical markers with the newest measurement technology, to provide trusted results to patients and clinicians,” stated Ms. Ameera Shah, Managing Director of Metropolis Healthcare Ltd. “We are delighted to offer MammaTyper® in our testing service in partnership with BioNTech. ”

MammaTyper® is a CE/IVD marked molecular in vitro diagnostic test for quantitative detection of the mRNA expression status of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and of MKI67 (proliferation marker Ki-67) in the tumor tissue of female patients with newly diagnosed invasive breast cancer. The test has been validated for total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tissue specimen or biopsies.

Dr. Kirti Chadha, Metropolis’ lead Onco-pathologist added, “The partnership with BioNTech allows Metropolis to expand our offerings with this test’s unmatched precision in molecular oncology, working towards a common vision for both companies to offer high quality testing at an affordable price.”

MammaTyper® is used for molecular subtyping of breast cancer tissue into luminal A-like, luminal B-like (HER2 negative), luminal B-like (HER2 positive), HER2 positive (non-luminal) and triple negative (ductal) tumors, and with further clinical pathological factors, offers the possibility of significantly improving the diagnosis and treatment path of female patients with breast cancer. All newly diagnosed invasive breast cancer samples from female patients are eligible to be tested with MammaTyper®, providing same-day results. MammaTyper® underscores BioNTech’s commitment to making personalized medicine widely available for the treatment of cancer.

About BioNTech Diagnostics GmbH

BioNTech Diagnostics is a fully-owned subsidiary company of BioNTech AG. The ISO 9001/13485 certified Company has an extensive pipeline and product and service offering ranging from biomarker discovery and validation through molecular screening assays, patient stratification and companion diagnostics, to clinical monitoring, all operating within international regulatory standards. Early detection of diseases that have a high mortality rate, and the appropriate selection of therapies, are crucial for effective treatment of patients. BioNTech Diagnostics’ mission is to provide new and innovative diagnostic tests to help extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.

More information about BioNTech is available at www.biontech.de.

More information about MammaTyper® is available at www.mammatyper.com.

 About Metroplis Healthcare Ltd.

 Metropolis conducts more than 30 million medical tests a year impacting the lives of thousands across India and other emerging markets. It is catering to over 20,000 Laboratories, Hospitals, Nursing Homes and 200,000 consultants, and with 34 years of experience in delivering accurate reports, Metropolis has earned the reputation of being India’s only multinational chain of laboratories with a strong presence in India, South Asia, Africa and Middle East. Its network includes 150 state-of-art medical Laboratories with over 1,000 collection centres, processing over 4,500 varieties of medical tests. Metropolis, a 3,500 employee strong company, offers comprehensive testing in the areas of genetics biochemistry, molecular oncology, anatomic pathology, microbiology, hematology and immunochemistry, among others. The company is CLIA/CAP and NABL accredited, and follows the guidelines laid by GCLP. Metropolis has been awarded numerous accolades, including ‘Best pathology Lab In India’ by Modern Medicare in 2006, and ‘Best Diagnostic Company of the Year’ in 2010 by Frost & Sullivan. In 2015 Metropolis won the ‘Best Diagnostic Company Award’ at the National Awards for Excellence in Healthcare hosted by CMO Asia. Metropolis also won ‘Best Diagnostic Service Provider Award’ from VC Circle.

More information about Metropolis is available at www.metropolisindia.com.

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