News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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23andMe Submits Genetic Test Applications with the FDA

23andMe executives want the credibility that FDA clearance provides for its DNA tests and declared their intent to eventually support more clinical laboratory test applications

Offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information.

Now that debate is likely to heat up, because direct-to-consumer genetic testing company 23andMe recently submitted an application to the Food & Drug Administration (FDA) to review and clear its personalized DNA test for market.

On July 30, 23andMe delivered its first round of 510(k) documentation to the FDA. This is a first for the direct-to-consumer genetic testing industry. At the same time, by seeking FDA clearance for its genetic tests, 23andMe will raise interesting issues for the traditional clinical laboratory testing profession. (more…)

Stanford Medical Students Undergo Genetic Testing to Study Their Own Genotypes

Pathology departments may want to create similar courses to teach medical students how to interpret genetic and genotyping tests

Genetic testing of participating university students was part of a special class that was conducted at the Stanford University School of Medicine last summer. The genetic pathology test was voluntary for the 54 students who participated in the eight-week course that was designed by a student.

The genotyping happened as part of the class, titled “Genetics-210, Genomics and Personalized Medicine.” It was intended to help medical students learn how to interpret genetic tests, and also to help them gain an understanding of ho learning the results of such tests could affect future patients.

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