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A federal council's recognition of the role of studying patient subgroups in comparative effectiveness research increases the chance that personalized medicine initiatives will be a key feature of healthcare reform, government officials and industry observers said.

In a paper published in Public Health Genomics, GPPC emphasizes that the need for a genetic test registry has been exacerbated by the rapid growth in the availability of genetic tests and the marketing of these products directly to consumers.

In a public meeting on transparency, the group asks for tests and related information to be posted at NCBI.

Without PGx-guided dosing information, it is unclear whether genetic testing to gauge Plavix response will go the same way as genetic testing for warfarin. At least one national insurer, Aetna, feels that the FDA did not provide enough information in the updated label to warrant coverage for the intervention.

A Coriell Institute official said that the personalized medicine project has so far enrolled 4,000 participants, and at this rate is hoping to meet its goal of 10,000 participants by 2010.

Although no specific regulatory efforts were discussed during an online meeting held this week, it was apparent from the comments of agency officials that the issue of direct-to-consumer genetic testing is on the radar of both CMS and FDA.

Luminex, BD, and Prodesse all immediately complied with FDA's instructions in removing statements from their websites related to tests for the 2009 H1N1 flu virus.

The personalized medicine advocates urged the new secretary to develop "a new regulatory framework" and to only put in place oversight policies that are "clearly stated and publicly vetted" beforehand.

Warren Bruggeman, Thomas Herzog, Lee Potts, Corey Goodman, Gregory Webb, Stephen Sands, Maggie Dias, Santiago Galvez, Elizabeth Goodman, Claudia Hillinger, Thad Seymour, Randy Scott, John Spencer, Thomas Stevens, Jim Talton, Daniel Wahby, Stephanie Warrington, Claudia Zylberberg

The firms amended a 2003 alliance for development and commercialization of a molecular diagnostic assay for prostate cancer based on the PCA3 biomarker. Gen-Probe also agreed to make a $5 million equity investment in DiagnoCure.


The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.