Genetic Testing & CLIA Test
CyGene Direct offers Clinical Laboratory Improvement Amendment genetic tests

All CyGene Genetic Testing &DNA Analyses are conducted at our in-house CLIA certified laboratory, ensuring that your test results reflect the highest clinical standards for laboratory testing. Authorized by Congress, CLIA certification is awarded by the United States Food and Drug Administration and is regulated by the Centers for Medicare and Medicaid Services. CLIA stands for Clinical Laboratory Improvement Amendments of 1988 and the CLIA Program sets standards and issues certificates for clinical laboratory testing.

CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information (1) for the diagnosis, prevention, or treatment of disease or impairment, and (2) for the assessment of health. An objective of the CLIA test is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.

Why CLIA Certification is important

CLIA Certification is important for your personalized genetics report because having your tests performed at a federally recognized facility encourages more physicians to recommend and utilize these important genetic tests. CLIA designation also makes the tests eligible for insurance reimbursement, further denoting their relevance to preventative health strategies and active treatment programs.

CyGene Laboratories, Inc. received CLIA certification in 2007 and is registered under CLIA ID Number 10D1064211 which expires April 2, 2011.