BIOTYPE GmbH and STRATIFYER Molecular Pathology GmbH Announce Strategic Collaboration to Advance Precision Medicine for Bladder Cancer Patients

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BIOTYPE GmbH and STRATIFYER Molecular Pathology GmbH are pleased to announce their strategic collaboration aimed to develop innovative diagnostic tests to improve outcomes for patients with bladder cancer. By combining their expertise, the two German companies seek to develop novel diagnostic tests for molecular stratification, enabling precision medicine approaches to improve patient outcomes.

Bladder cancer is a prevalent malignancy with substantial healthcare costs due to the lifelong surveillance required. Recent breakthroughs in clinical studies have revealed the benefits of targeted therapies for patients with advanced or metastatic urothelial cancer, particularly those with alterations in FGFR genes. The collaboration between BIOTYPE and STRATIFYER aims to harness these advancements and usher in a new era of personalized medicine for bladder cancer patients.

STRATIFYER, renowned for its translational research capabilities, brings extensive expertise in clinical study design and clinical research to the collaboration. Notably, the company's register study for bladder cancer, known as BLADDER BRIDGister, has generated actionable molecular markers that guide the use of therapeutic options. Leveraging this proprietary data, STRATIFYER will contribute its findings to support the development of in vitro diagnostic assays.

BIOTYPE, a vertically integrated in vitro diagnostics, and medical device company, excels in the development, manufacturing, and distribution of products and systems for molecular diagnostics and nucleic acid analysis. Through its proprietary MODAPLEX platform, BIOTYPE offers automated analysis of biomarkers. Building on STRATIFYER's actionable markers, BIOTYPE will develop in vitro diagnostic assays for MODAPLEX. This collaborative effort will enable same-day results and actionable insights through molecular profiling.

Initial focus of the partnership will be on developing novel assays for molecular profiling of FGFR-specific biomarker signatures, that identify additional therapy candidates apart from standard FGFR mutation/fusion assessment for targeted FGFR therapy & treatment combinations. These assays will undergo validation in large patient cohorts participating in ongoing clinical studies. By performing multilayer precision diagnostics integrating mutation, fusion, expression, and amplification analyses of potential target genes in modular assay formats at one time on one platform, the collaboration aims to provide patients with access to in-depth precision medicine tailored to their individual needs.

“We are excited to join forces with STRATIFYER in our mission to enhance precision medicine for bladder cancer patients,” said Dr. Norman Gerstner, CEO of BIOTYPE. “This collaboration brings together the complementary strengths of both companies, allowing us to leverage our respective expertise to develop innovative diagnostic tests. Together, we strive to improve patient outcomes and make a significant impact in the field of bladder cancer research.”

Dr. Ralph M. Wirtz, CEO of STRATIFYER, stated, “Our collaboration with BIOTYPE represents a unique opportunity to translate our research findings into actionable diagnostics that will benefit bladder cancer patients. By combining our extensive clinical expertise with BIOTYPE’s cutting-edge technology, we aim to unlock new possibilities for precision medicine and drive advancements in the field.”

The strategic collaboration between BIOTYPE GmbH and STRATIFYER Molecular Pathology GmbH holds great promise for the future of bladder cancer diagnosis and treatment. Through their joint efforts, these two German companies are dedicated to improving access to precision medicine, ultimately transforming the lives of patients with bladder cancer.

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