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Agreements

Date: 2017-08-09

Type of information: Commercialisation agreement

Compound: MammaTyper®

Company: BioNTech (Germany) Metropolis Healthcare (India)

Therapeutic area: Cancer - Oncology - Diagnostic

Type agreement: commercialisation

Action mechanism:

  • stratification test/companion diagnostic
  • 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.

Disease: breast cancer

Details:

  • • On August 9, 2017, BioNTech Diagnostics, a fully–owned subsidiary of BioNTech, a company pioneering individualized cancer immunotherapy and diagnostics, and Metropolis Healthcare, India’s leading chain of pathology labs and diagnostics centers announced a 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. 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.

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