2015 Genomic Express receives untitled letter from FDA

December 10, 2015  (Westlake Village, CA)

Genomic Express received a letter dated December 7, 2015 from the U.S. Food and Drug Administration (FDA).  The letter requested additional information about our pharmacogenetic (PGx) tests: Clopidogrel (Plavix^®) response, Tamoxifen (Nolvadex^®) response, and Warfarin (Coumadin^®) sensitivity genetic tests.  In particular, the letter noted the “direct to consumer” availability of these tests. The letter from the FDA may be viewed here.

Grant A. Bitter, Ph.D., Genomic Express Founder and CEO, stated that the Company will prepare and submit a detailed response to the FDA letter providing the requested information. Dr. Bitter further noted that an untitled letter from the FDA is not a warning or enforcement letter. Rather, it is a request by the agency for additional information as specified in the letter.