“In one of the largest genetic testing fraud cases ever tried to verdict, today’s sentence makes clear that the Department will seek justice for those who put profits above patient care, including owners and executives,” said Acting Assistant Attorney General Nicole...
Many DTC (Direct-to-Consumer) tests use a polygenic risk score (PRS) to ESTIMATE that individuals potential disease risk. The LACK of regulation in the Laboratory Developed Testing (LDT) also extends into a market that targets consumers for “wellness”...
Can labs that aren’t regulated by the FDA create whatever “claims” they wish pertaining to the performance of the test? YES! Does this false advertising ultimately hurt patients? YES! A recent article published by GenomeWeb stated...
Everyone from the genetic, genomic, lab, and pharmaindustry should at this point understand that there are “gaps” currently when assuring quality of NGS (Next Generation Sequencing) based testing in CLINICAL laboratory settings. This working...
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