Therapy Areas: Devices
Genomic Testing Cooperative Receive CE-IVD Marks for Hematology Profile Plus, Solid Tumor Profile Plus, and Liquid Biopsy Profiles
26 May 2022 - - US-based molecular testing company Genomic Testing Cooperative (GTC) has 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 company said.

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.

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.

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.

Genomic Testing Cooperative is a privately-owned molecular testing company located in Irvine, CA. The company operates based on a cooperative (co-op) business model. Members of the co-op hold type A shares with voting rights.

The company offers its patron members a full suite of comprehensive genomic profiling based mainly on next generation sequencing.

The co-op model allows GTC to make the testing and information platform available to members at a lower cost because of a lower overhead.

TherapySelect was founded by Dr. Frank Kischkel. It is a biotech and medtech company focusing on development, clinical validation, marketing and sales of diagnostic tests for cancer patients.

The company's aim is to increase patient survival and quality of life as well as to reduce costs in health care system.