MINNEAPOLIS (DECEMBER 5, 2018) — OneOme, co-developed by Mayo Clinic, today announced that it has received approval from New York State Department of Health to offer its pharmacogenomic testing in New York. OneOme now can offer its RightMed comprehensive test in all 50 states and numerous international locations. The RightMed test is a medication response test, also known as a pharmacogenomic test, that analyzes a patient’s DNA to help predict how they may respond to medications.
“This is an accomplishment that further demonstrates OneOme’s commitment to quality and compliance, along with our previously obtained certification and accreditation from CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists),” said Bronwyn Hartung, PhD, HCLD(ABB), laboratory director of OneOme. “Receiving accreditation from New York state is a rigorous process, and we are proud to have met such high standards.”
The process included a certification that the laboratory director meets stringent education and experience requirements, approval of the lab facility after a thorough on-site inspection, review of all test method and clinical validity claims, and confirmation that all lab personnel meet strict qualification requirements for their assigned roles.
“We are excited to have reached this prestigious milestone. It’s a testament to our mission to deliver the most cost-effective, comprehensive, clinically actionable pharmacogenomic solution across the nation and the globe,” said Paul Owen, CEO of OneOme.
OneOme’s RightMed test is a provider-ordered test that analyzes a person’s DNA to help predict how they may respond to hundreds of medications used to treat 30 medical conditions, including psychiatric conditions, cancer, chronic pain, cardiovascular disease, and more.
OneOme was co-founded with Mayo Clinic to bring pharmacogenomics into routine clinical care. OneOme is a privately held company backed by early-stage venture firm Invenshure, LLC, and Mayo Clinic. To learn more about OneOme, visit oneome.com.