Response Genetics’ Cancer Tissue Test Added to Genetic Testing Registry
Los Angeles-based Response Genetics, a cancer therapy diagnostic testing company, said Thursday that the National Institutes of Health’s Genetic Testing Registry will now include the company’s ResponseDX: Tissue of Origin test.
The NIH registry, a searchable database of genetic and genomic tests, offers detailed clinical and scientific information about testing options for physicians and patients, and ResponseDX is the only FDA-cleared test to identify the tissue in which a malignancy originates, the company said.
Response Genetics acquired the test in late 2013 along with other assets purchased from PathWork Diagnostics. It received 510(k) clearance from the FDA cleared in 2008, and Response launched it in February of this year.
CEO Thomas Bologna said the test’s inclusion in the registry is a great benefit to the community of oncologists, pathologists and patients the company serves. He added that the entry on ResponseDX will include in-depth information about the test's development, validation and clinical utility, and will be easily accessible to all. — Kellen Owings
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