Exagen Diagnostics Leads Next Phase Of Genomics Revolution

Exagen Diagnostics today announced that it filed for U.S. Food and Drug Administration (FDA) review of the first of six products currently in the Exagen pipeline. This product, eXagenBC, is a DNA-based test that identifies risk of recurrence in breast cancer patients and allows physicians to more accurately predict prognostic outcome. Exagen develops and commercializes genomic marker-based in vitro diagnostic (IVD) kits that provide diagnostic and prognostic information allowing targeted treatments and assisting physicians. Unlike currently available tests that require treating physicians to use a single laboratory in the United States, Exagen’s tests can be performed and analyzed at any qualified laboratory, resulting in lower costs, reduced complexity and faster turn-around time of results for physicians and patients. “We’re very excited that, anticipating increasing FDA involvement in our industry, we are now submitting to the FDA a genomic marker test that can easily be applied and interpreted by local laboratories across the United States,” said James A. McClintic, Chief Executive Officer of Exagen. “This filing is the first of many to come from Exagen. These genomic-based tests will put the power of ‘personalized medicine’ in the hands of physicians, allowing them to make the best diagnosis and most accurate prognosis, and to determine the optimal course of treatment based on each patient’s unique DNA sequence.” Exagen Diagnostics uses high-performance computer models to discover combinations of genes that can be developed as clinical laboratory tests used in patient care and pharmaceutical clinical trials. The company’s proprietary software provides a powerful computational biology platform that reduces from years to weeks the time it takes to discover new genomic markers useful in clinical medicine in a wide variety of therapeutic areas. “Molecular testing of patient samples may help physicians personalize their treatment recommendation by taking into account the unique genetic characteristics of individual patients,” explains Raymond Tubbs, D.O., Section Head for Molecular Genetic Pathology and Chairman of the Department of Clinical Pathology at the Cleveland Clinic, which conducted one aspect of the clinical trial for eXagenBC. “A FISH (fluorescent in situ hybridization) assay for moderately complex tumor signatures can be validated and implemented in qualified molecular pathology clinical laboratories having FISH capabilities." “Exagen’s linkage of computational discovery to the development of molecular diagnostic tests for patient care will substantially advance personalized medicine,” stated Thomas Williams, M.D., Chief Scientific Officer of Exagen. “Our team of scientists created a unique technology platform that allows the rapid discovery of biomarkers that can be applied to a wide range of different medical indications. The breast cancer prognostic assay is the first test from Exagen, and there are many more to follow.” SOURCE: Exagen Diagnostics, Inc.