Close Menu

Amgen

"The promise of genomics in the practice of medicine is great and exciting, but today the use of personal genomic tests is still not ready for prime time," a CDC official said in a video address to doctors and the general public.

Researchers from Decode Genetics and elsewhere reported that a genetic variant tied to chronic kidney disease may influence individuals' response to related diseases and environmental stressors in this population over time.

A week after being hit with a GAO report that called test results from consumer genetics firms "misleading," the big three DTC companies criticized the agency for using "unscientific" methods in its undercover investigation, but welcomed greater regulatory oversight.

During the latter part of a two-day meeting to discuss FDA's stated intent to regulate laboratory-developed tests, most speakers agreed that the FDA should bring consistency to direct-to-consumer genomic risk interpretations, and promulgate standard practices for the industry developed either by an expert advisory panel or a third-party standard-setting body.

ARUP will begin offering the test, which measures 25 common SNPs associated with prostate cancer risk, in the fall.

Pharmacogenomics Reporter took stock of industry expectations ahead of FDA's upcoming meeting to discuss the agency's strategy for regulating laboratory-developed tests.

Paired Ends: Jun 29, 2010

Premium

Alan Sherr, Hartmut Voss, Cord Stähler, Sandeep Nayyar, Lee Hood, Alison Symington

In letters to Illumina, Knome, 23andMe, Navigenics, and Decode, the FDA asserts that DTC genomics firms are marketing medical devices and informs several of these companies that their tests are not laboratory-developed tests that would fall under the purview of CMS.

The letters are the FDA's latest efforts to assert that DTC genomics service providers are using devices that are actually diagnostic products that require marketing clearance.

The House Committee on Energy and Commerce has sent letters to Pathway Genomics, 23andMe, and Navigenics requesting information about their services.

Pages

A new study catalogues the genome and evolutionary history of the oak family, UPI reports.

Dog DNA testing is a growing market, but there's still a lot of uncertainty about the accuracy of the results, the Boston Globe says.

A University of South Florida researcher is testing bone fragments to determine if they belong to Amelia Earhart.

In Cell this week: antisense Piwi-interacting RNA responses to endogenous retroviruses, proteomic patterns in hepatocellular carcinoma, and more.