BIOTYPE launches fast-track multi-biomarker assays to detect actionable FGFR genetic alterations in bladder cancer samples

Dresden, 26th August 2024 – BIOTYPE GmbH, an internationally operating precision diagnostics company, announced today the launch of their latest additions to the MODAPLEX Molecular Profiling portfolio of highly multiplexed PCR-based assays:

the MODAPLEX FGFR3 Mutation Kit (RUO) and the MODAPLEX FGFR Gene Fusion Kit (RUO). These assays are designed to detect actionable FGFR alterations in urothelial cancer samples in under 5 hours using BIOTYPE’s proprietary MODAPLEX platform.  This closed platform offers advanced multiplexing and highest concordance to standard PCR and NGS assays. The integrated and simple one-step reverse transcriptase-PCR workflow comes with automated data analysis.

In detail, the MODAPLEX FGFR3 Mutation Kit (RUO) enables clinical researchers a rapid and accurate simultaneous detection and discrimination of 13 actionable FGFR3 mutations in RNA extracted from formalin-fixed paraffin-embedded (FFPE) tissue samples. In addition, the MODAPLEX FGFR Gene Fusion Kit (RUO) allows for parallel detection of 12 clinically relevant gene fusions of the FGFR2 and FGFR3 genes including 7 variants of FGFR3::TACC3. Both assays run in parallel under the same protocol. Through this consolidated workflow a fast and cost-efficient analysis of actionable FGFR3 alterations in urothelial cancers samples becomes available to the molecular oncology community.

All MODAPLEX kits include a robust control concept, including template-dependent and template-independent internal controls allowing for assessing the sample integrity and PCR quality, hence ensuring reliable and accurate results. Both assays are intended for research use only and must be validated by accredited laboratories with clinically relevant material for diagnostic purposes.

"With the MODAPLEX FGFR Panel, bladder cancer researchers can rapidly and reliably detect actionable FGFR3 alterations with high sensitivity and specificity, even from low sample amounts", said Norman Gerstner, CEO of BIOTYPE. "This recent product addition supports our ongoing menu expansion for the MODAPLEX platform and our commitment to support the molecular oncology community with solutions for fast and automated molecular profiling", Gerstner added. "We are pleased to announce this launch resulting from a successful collaboration with the STRATIFYER Molecular Pathology GmbH, an expert in translational research and clinical trials for precision oncology". Gerstner continued "We look forward to expanding our MODAPLEX test menu with assays that support translational and clinical research in biomarker-guided cancer care. Through the MODAPLEX technology, a combination of PCR and Capillary Electrophoresis with automated data analysis, multi-gene testing and analysis of targeted biomarker panels becomes as simple as running a standard PCR.", Gerstner emphasized.

To learn more about the MODAPLEX FGFR3 Mutation and Gene Fusion Kits, visit www.biotype.de or contact products@biotype.de

Media Contact:

BIOTYPE GmbH
Moritzburger Weg 67
01109 Dresden
products@biotype.de
Tel.: +49 351 8838 400

About BIOTYPE

BIOTYPE is a German molecular diagnostics company developing, manufacturing, and marketing high-quality products for translational research and clinical diagnostics. As part of the Molecular Diagnostics Group (MDG), BIOTYPE offers a strong portfolio in molecular cancer diagnostics for applications in hemato-oncology, liquid biopsy, and molecular profiling of solid tumors. Customers include universities, research institutions, hospitals, clinical laboratories, molecular pathologies and biopharmaceutical companies. Together with the companies of MDG, its partners and customers, BIOTYPE develops innovative multi-biomarker tests of highest quality that deliver actionable insights and improve patient outcomes.

More information: https://www.biotype.de

About STRATIFYER

STRATIFYER Molecular Pathology combines more than 20 years of research & development experience in the field of molecular biology with that of clinical pathology. Moreover, long-term intensive cooperation with leading German and international oncologists broadens the scientific background of STRATIFYER Molecular Pathology.

More information: http://www.stratifyer.de