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At a March meeting with industry groups, the FDA gathered comments regarding the barriers to drug/diagnostic codevelopment and noted the agency might issue a series of white papers on the topic.

The industry standards issued last December by 23andMe, Decode, and Navigenics are "a good start, but they are really not where they need to be," said Muin Khoury, director of the CDC's Office of Public Health Genomics.

Citing the FDA's handling of KRAS testing for anti-EGFR monoclonal antibodies, the report asserts that in the near term complex genetic tests such as Oncotype DX should be "performed through CLIA labs, and not held up by slow regulatory processes."

The firm, beset with rising debt, the ongoing global financial crisis, and a complicated corporate structure, is currently "engaged in negotiations" regarding alternatives to bring in additional cash.

By offering SNP data on warfarin sensitivity, 23andMe may be gearing up to recruit participants for future research projects seeking new gene associations and the clinical utility of pharmacogenomics-guided warfarin dosing.

Decode's Q4 revenues rose 21 percent, but the firm said that it only has enough liquid assets to fund operations into the second quarter of this year.

Some in the clinical genetics community believe the rise of DTC testing offers a prime opportunity to raise awareness of genetics among the general population, despite skepticism about using the tests for clinical decision-making.

New Releases: Mar 25, 2009

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DxS' TheraScreen KRAS Mutation Kit

Jerry Hill, Chad Ziegler, Michael Allen Luther, Drew Harris, Christopher Donovan

DxS get EU approval to sell its TheraScreen K-RAS Mutation Kit for use on Roche's LightCycler instrument and licensed rights to related software.

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A South African university has told the Wellcome Sanger Institute to return DNA samples it has from indigenous African communities, The Times reports.

The University of California, Berkeley's Rasmus Nielsen and Xinzhu Wei have retracted their CCR5 gene paper due to a technical artifact.

 

University of Virginia researchers are exploring a genetic risk test to gauge type 1 diabetes risk, NPR reports.

In PNAS this week: researchers compare two high-grade neuroendocrine lung cancers, height among ancient Europeans, and more.