2016 FDA review of Genomic Express PGx tests completed

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.

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.

2012 Genomic Express introduces pharmacogenetic testing

March 1, 2012 (Westlake Village, CA)

Genomic Express, Inc. has introduced pharmacogenetic testing to its panel of medical genetic tests. These tests can determine whether a patient responds to a medication. Secondarily, the test result may be used by the patient’s physician to adjust the medication dose to be both safe and effective.

As many as 50% or more of the population may not respond to certain prescription medications. These individuals do not derive any clinical benefit from the drug. Furthermore, as all medications have at least some adverse effects, individuals who are non-responders are unnecessarily increasing their risk for other health problems by taking the medication. The use of prescription medications by non-responders to the drug is one of the factors that contributes significantly to the high costs health care.

The first pharmacogenetic test offered by Genomic Express is for warfarin sensitivity. Warfarin is marketed most commonly under the tradename Coumadin^® and is used to prevent formation of blood clots in a number of clinical settings. Warfarin is the most widely prescribed anticoagulant in North America. Although it has been used for over 50 years with proven therapeutic benefit, correct dosing has remained problematic. There is considerable variability in response to warfarin, and patients with dosing that is too high have increased risk of hemorrhage, which may be fatal. If the dosing is too low, the patient remains at increased risk of thrombosis, which may also be fatal. Although genetic testing for warfarin sensitivity is not routinely used at this time, approximately 40-50% of the variability in warfarin response is due to genetic factors, The AEI-Brookings Institute has estimated that if genetic testing was routinely used in initial warfarin dosing, it would prevent 85,000 serious bleeding events and 15,000 strokes per year. In 2007, the U.S. Food and Drug Administration (FDA) included a black box warning on the package insert that response to warfarin is genetically determined. In 2010, the FDA provided specific guidance on expected stable maintenance dose based on these genetic factors, and this information now appears on the package insert. The warfarin sensitivity genetic test offered by Genomic Express provides this genotype information for each patient. This genetic information can be used by their physician to prescribe doses which are both safe and efficacious.

“With the completion of the human genome project in 2003, we are now entering the era of personalized medicine where healthcare is improved by tailoring treatment to the individual patient" stated Dr. Grant A. Bitter, founder and C.E.O. of Genomic Express. “We believe pharmacogenetic testing is the most valuable form of personalized medicine at this time, and are pleased to make these new tests available to patients and their healthcare providers.”

2012 Genomic Express Completes CLIA Certification/Accreditation

February 3, 2012 (Westlake Village, CA)

Genomic Express, Inc. has completed CLIA certification for its molecular genetics laboratory in Westlake Village, CA. Previously, in April, 2011, a Clinical Laboratory License was issued by the California Department of Public Health (CDPH) and a CLIA Certificate of Registration for high complexity testing was issued by the U.S Center for Medicare and Medicaid Services (CMS).

In October, 2011 and February, 2012 Genomic Express was re-inspected by CDPH and CMS. The Genomic Express laboratory was found to be in full compliance with CLIA regulations, with no deficiencies. A CLIA Certificate of Compliance for high complexity testing was issued by the CMS.