April 29, 2016 (Westlake Village, CA)
Genomic Express received an untitled letter dated December 7, 2015 from the U.S. Food and Drug Administration (FDA). The subsequent review by the FDA of Genomic Express pharmacogenetic (PGx) tests concluded that the tests are laboratory developed tests (LDTs), and do not require FDA clearance as medical devices. The agency further stated that the tests may continue to be offered by the Genomic Express CLIA certified laboratory without any change in the Company’s associated operational procedures. This includes making these valuable pharmacogenetic tests available directly to consumers (DTC) through www.GenomicExpress.com
Grant A. Bitter, Ph.D., Founder and CEO of Genomic Express, noted that since 2011 the Company’s laboratory has been CLIA certified by CMS, and a California licensed clinical laboratory. Dr. Bitter further stated that when Genomic Express made these tests available through the Company’s website, careful consideration was given to all existing and anticipated regulatory requirements. “We are pleased that the FDA’s thorough review of our operational procedures has determined that Genomic Express is in full compliance with all current regulatory requirements”, Dr. Bitter added.