Pharma Focus Asia

Genomic Testing Cooperative Hematology Profile Plus, Solid Tumor Profile Plus, and Liquid Biopsy Profiles Receive CE-IVD Mark

Thursday, May 26, 2022

Genomic Testing Cooperative (GTC) today announced it received CE-IVD marks for its Hematology Profile Plus, Solid Tumor Plus as well as its liquid biopsy profiles for both solid tumors and hematology that are designed to provide a wide range of clinically actionable insights about a patient’s tumor.  The CE mark will allow GTC and its partner, TherapySelect (Heidelberg, Germany), to make available GTC’s menu of DNA and targeted transcriptome profiling for patients in Europe. The Solid Tumor Profile Plus provides information on targetable mutations, fusion genes, tumor cell of origin, and the presence or absence of homologous recombination deficiency (HRD).  The Hematology Profile Plus provides molecular data for selecting targeted therapy and also accurate diagnosis and classification of various myeloid and lymphoid neoplasms including gene fusions, chromosomal gains and losses, and molecular immunoprofiling.  The Hematology Liquid Biopsy Profile is designed to reduce the need for bone marrow biopsy in certain circumstances.  The Solid Tumor Liquid Biopsy Profile is designed for tumor-informed monitoring.  

“We are excited to expand our molecular profiling offerings to Europe and to make membership in the Cooperative available internationally. This will strengthen the network and accelerate innovation by building broader knowledge-based artificial intelligence algorithms,“ stated Dr. Maher Albitar, Founder, Chief Executive Officer and Chief Medical Officer, GTC.

Dr. Frank Kischkel, Managing Director and Scientific Director at TherapySelect stated, “We elected to partner with GTC because of the superior quality and comprehensive offering of the tests along with their commitment to innovation.  GTC tests are designed with patients and best practices in oncology in mind. In addition, the co-op business model allows us to internalize the testing in our laboratories as our volumes grow in Europe.  We are very excited to be GTC’s authorized representative in Europe and look forward to growing our partnership.”

TherapySelect will be the authorized representative in the EU to offer CE certified in vitro diagnostic medical devices. Membership in the Co-Op allows other member labs to internalize GTC testing, which now includes the EU and countries recognizing the CE mark.

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