Sep 14, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Uncategorized
Mobile testing truck makes DNA testing approachable and accessible to the community while competing with established clinical laboratories
You may have seen recent news coverage of a van cruising the streets of New York City that was offering on-the-spot DNA testing with signs plastered on sides reading “Who’s Your Daddy”—“DNA Testing.” Certainlyany passing pathologist or clinical chemist might do a double take.
According to abc News coverage of the story, passersby can hail the 28-foot recreational vehicle to have their DNA tested. Of course, no testing is performed in the mobile van. Rather, a technician collects a sample from the customer, packages it, and sends it to a laboratory in Ohio for testing. Results come back in three to five days. Prices for the testing service start at $299. (more…)
Aug 6, 2012 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
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…)
