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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


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.

"The fact is that Pathway's bold move to make themselves noticed achieved its end and brought them to our attention," an FDA official told Pharmacogenomics Reporter.

The FDA said that in expanding its DTC genomics service from the internet to Walgreens, Pathway Genomics "has moved outside of the currently sanctioned boundaries for laboratory-developed tests."

In the study, Amgen researchers and academic collaborators used the Roche 454 Life Sciences platform to sequence nine genes in 320 tumor samples from a clinical trial of the EGFR inhibitor Vectibix. It represents one of the first applications of next-gen sequencing to characterize samples from a clinical trial.


A letter criticizing actions by the US government and research institutions toward Chinese and Chinese-American scientists has garnered more than a hundred signatories.

NPR reports that researchers in New York are investigating whether it is possible to edit the genomes of human sperm.

In an opinion piece at the Nation, Sarah Lawrence College's Laura Hercher argues that everyone should be able to access prenatal genetic testing.

In Nature this week: ancient DNA uncovers presence of Mediterranean migrants at a Himalayan lake, and more.