Results of Undercover Assessment Suggest Clinical Laboratory Companies Need to Raise the Bar on Quality Control of Non-Invasive Prenatal Tests

Feb 9, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology

Three out of five NIPT laboratories returned normal or negative test results for samples taken from non-pregnant women in undercover test performance assessment Clinical laboratory companies that offer genetic tests may want to be on the alert. Secret shoppers are submitting specimens for the purpose of assessing the quality, the accuracy, and the clinical relevance of the proprietary medical laboratory tests they perform. One such report was published in GenomeWeb under the title “Undercover...

Do Some Clinical Laboratory Companies Oversell Prenatal Genetic Screening Tests?

Jan 12, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

A growing number of media stories claim medical lab companies that develop genetic screening assays oversell the accuracy of such tests and fail to educate parents and doctors about the risks of false positives and false negatives In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry. What gives these news stories emotional punch is the fact that...
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