“MyOme Develops Cross-Ancestry Breast Cancer Polygenic Risk Score, Plans Product Launch” — GenomeWeb

The MyOme Personal Genome Report was developed, and its performance characteristics were determined, by MyOme, Inc., a clinical laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity clinical laboratory testing. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary for laboratory-developed tests.