NEW YORK — Genomic Testing Cooperative (GTC) said on Wednesday that it has received CE-IVD marking for two of its next-generation sequencing-based cancer tests, as well as liquid biopsy profiles.
The tests include GTC-Hematology Profile Plus, which looks for hematologic cancer-associated mutations across 179 DNA genes and 1,408 RNA genes, and GTC-Solid Tumor Plus, which detects solid tumor-linked abnormalities in 434 genes and fusion, expression, and mutations in more than 60 genes.
GTC also received CE-IVD marks for its Hematology Liquid Biopsy Profile, which is designed to reduce the need for bone marrow biopsy in certain circumstances, and its Solid Tumor Liquid Biopsy Profile, which is designed for tumor-informed monitoring.
With the CE-IVD marking, GTC said that it will offer the tests and liquid biopsy profiles throughout the EU with Heidelberg, Germany-based partner TherapySelect.
About a year ago, Irvine, California-based GTC received New York state approval and Medicare coverage for GTC-Hematology Profile Plus and GTC-Solid Tumor Plus, as well as certain other tests.