Genemarkers is proud to announce today that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) approved Genemarkers pharmacogenomic (PGx) test panels. CLEP approval means that healthcare providers in New York can now utilize Genemarkers PGx tests in their clinical practice.
“This is an important milestone for us. CLEP approval is one of the toughest accreditations to achieve, and our staff did an excellent job meeting the bar,” said Anna Langerveld, Founder and CEO at Genemarkers. “We have always maintained a commitment to excellence in laboratory practices that aligns with our core value of providing the highest quality results to patients. Achieving CLEP approval is a realization of this.”
CLEP seeks to ensure the accuracy and reliability of test results and laboratory procedures. The organization regulates clinical diagnostic laboratories that test biological specimens within New York and samples collected from the residents of New York.
“Genemarkers is accredited by CAP and holds a NY State Permit for PGX testing. This allows Genemarkers to offer PGx testing in all 50 states and demonstrates they adhere to the highest regulatory standards,” stated Jeanne Ohrnberger, PhD, HCLD, Clinical Laboratory Director at Genemarkers. Pharmacogenomic (PGx) testing identifies variants in a patient’s DNA that affect how the individual responds to specific medications. PGx testing can help increase the quality of patient care and decrease adverse drug events, healthcare costs, and hospitalization for patients who undergo testing.
Genemarkers remains committed to creating tests that include only drug-gene pairs with the highest levels of clinical validity and utility. Genemarkers’ PGx tests include drug-gene pairs that the Food and Drug Administration (FDA) and the Clinical Pharmacogenomics Implementation Consortium (CPIC) have recognized as having scientific evidence to support clinical use. Genemarkers currently offers three multi-gene PGx panels and two single-gene tests. Genemarkers’ clients utilize the results of PGx testing to predict medication safety, efficacy, and toxicity for their patients.