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

"NEW YORK – Personalized genomics company MyOme presented data at the recent American Society of Clinical Oncology conference demonstrating its ability to train and validate a cross-ancestry polygenic risk score (caPRS) for breast cancer."

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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.