Genomic Testing Coop. Gets CE-IVD Mark for Hematology, Solid Tumor Tests

Irvine, Calif.-based Genomic Testing Cooperative, a molecular testing company, has received CE-IVD marks for its Hematology Profile Plus and Solid Tumor Plus tests.

The hematology test, which provides molecular data for selecting targeted therapy, accurate diagnosis and classification of abnormal growths, can reduce the need for bone marrow biopsy in certain circumstances, the company said.

The tumor profile provides information on targetable mutations, fusion genes and the tumor cell of origin. It also identifies the presence or absence of homologous recombination deficiency (HRD), a condition in which the body is unable to repair breaks in DNA. Tumor cells in individuals with HRD may be unable to repair themselves.