OneOme Receives Laboratory Clinical Certification from Five States

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Certification Reaffirms OneOme’s High Standards of Laboratory Quality

OneOme laboratory

OneOme laboratory

Earning these certifications is a significant step toward our goal of making prescriptions personal for patients around the world.

Twin Cities-based pharmacogenomics company OneOme announced today that it has earned laboratory certification in California, Florida, Maryland, Pennsylvania, and Rhode Island. These certifications affirm OneOme’s commitment to exceeding the specific clinical laboratory testing and quality standards required by these five states. OneOme will immediately begin accepting orders from these states for its RightMed® pharmacogenomic test, which analyzes a patient’s genetic profile to determine whether certain medications might be effective for that patient.

“Earning these certifications is a significant step toward our goal of making prescriptions personal for patients around the world,” said Paul Owen, CEO of OneOme. “OneOme is committed to delivering the highest quality pharmacogenomic services to healthcare providers and patients, and earning these certifications demonstrates we are achieving this goal.”

To receive the certifications, OneOme met each state’s rigorous requirements, including:

  •     Completing all the required documentation for the state.
  •     Providing evidence of compliance with CAP, CLIA, and applicable state-specific standards.
  •     Providing assay validation information.

With these certifications in place, OneOme is now able to offer its testing services in 49 states to date. OneOme will seek to obtain the remaining state laboratory certification from New York in 2017.

The RightMed test is a cost-effective, comprehensive, and clinically actionable pharmacogenomic test covering 22 genes, provided as a part of routine clinical care. The test, clinical report, and interactive online tools can help healthcare providers make timely, evidence-based personalized prescription treatment decisions for more than 340 medications. In addition to the RightMed test, OneOme has also developed a platform for clients to generate the interpretive drug report using genotype or sequence data obtained elsewhere.

Studies show about half of the four billion prescriptions issued each year do not work as intended, and adverse drug reactions are the fourth-leading cause of death in the U.S. Genetic factors have been shown to account for up to 95 percent of drug response variability, and the RightMed test can help to identify, based on genetics, which prescriptions may have a more favorable outcome on an individual patient basis. OneOme began offering its RightMed pharmacogenomic test in July 2016.

The RightMed test, which costs $249, is ordered by providers through a HIPAA-compliant portal at http://www.oneome.com, where results are made available and retained. Results are tested at OneOme’s new CAP-accredited clinical laboratory in Minneapolis.

Available worldwide, RightMed is currently available to more than 500,000 patients at Centra Health in the Centra Medical Group Stroobants Cardiovascular Center; in use by Mayo Clinic Center for Individualized Medicine (CIM); in Canada is available through OneOme’s partnership with Medcan, Canada’s largest executive health clinic and a global leader in assessing clients’ overall well-being; and in Puerto Rico, Cuba, and Dominican Republic through a partnership with High Profile Laboratory in Guaynabo, Puerto Rico.

The OneOme platform was co-developed and exclusively licensed from 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 http://www.oneome.com.

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Editor’s Note: Mayo Clinic has financial interest in the technology referenced in this news release. The revenue that Mayo Clinic will receive is used to support its not-for-profit mission in patient care, education and research.

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