What Is the CLIA Program?
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were developed to ensure quality laboratory testing and accurate, reliable, and timely test results. Through the CLIA program, the Centers for Medicare & Medicaid Services (CMS) regulates human diagnostic laboratory testing in the United States, separate from R&D, animal, and other GLP-governed testing. All CLIA-certified laboratories are subject to inspection by regulatory agencies to ensure they are complying with the regulations outlined in the statute.
Why Is the CLIA Program Important?
Medical professionals regularly use laboratory testing to assess a patient’s health or to diagnose, prevent, or treat a disease. The accuracy of laboratory testing can directly impact humans’ health and well-being – in some cases, it is even a life or death matter. Under this law, all entities that perform even one laboratory test on human specimens “for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” must obtain CLIA certification and comply with CLIA regulations. In the context of clinical trial testing, CLIA is applied when the result informs the evaluation of a patient’s disease state and could result in a change in the patient’s treatment or therapy. Typically, these are tests that determine inclusion or exclusion from or stratification in a clinical trial as well as Phase IV potential adverse effects evaluations.
Depending on the types of diagnostic tests conducted at a laboratory, that laboratory may need to obtain multiple types of CLIA certificates. QPS is accredited for CLIA high complexity testing in 49 states and omits New York. The QPS New York State Permit status is “Applied.”
QPS performs custom assay development and validation in accordance with both GCP and CLIA to support both diagnostic (e.g. inclusion/exclusion, stratification, etc.) and traditional clinical trial end points. Additionally, the QPS COVID (EUA-approved Thermo Fisher Scientific’s TaqPath™ COVID-19 Combo Kit) molecular diagnostic test is valid for all states, including New York.
QPS developed tests for COVID-19 viral load, and IgG and IgM serum antibodies are in development. They will be validated to GLP and CLIA standards and individual FDA EUAs will be pursued.