Although SACGHS has yet to finalize its recommendations to exempt diagnostic developers from infringing on gene-association patents, last week's meeting ignited a debate on whether such a recommendation can be acted upon by the HHS Secretary, whether this would harm innovation, and whether the committee's conclusions about gene patents' deleterious impact on patient access was support by evidence.
DTC personal genomics firms, such as 23andMe, "don't have a laboratory, but they do [genomic] interpretation," Penny Thompson, deputy director of CMS' Center for Medicaid and State Operations, said during a meeting of the HHS Secretary's Advisory Committee on Genetics, Health, and Society in Washington, DC, last week. "That doesn't fall under CLIA."
While the majority of the new funding will support genome-wide association studies, also benefiting from the federal stimulus package are research projects focused on copy number-variation analysis, gene expression, and bioinformatics.
The 970 grants awarded to 'omics projects comprise 7.5 percent of the NIH stimulus grants awarded so far, but the total funding awarded to these projects makes up 14 percent of NIH ARRA grant funding to date.
The SACGHS task force has suggested that genetic testing patents are not necessary for innovation and may, in some cases, block patient access. However, the recommendations are not final and are being discussed at a meeting in Washington, DC, this week.
Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.
According to the grant abstracts, the project is "an unprecedented partnership" between two large-scale sequencing centers — at Baylor College of Medicine and at the Broad Institute — and a network of research labs focused on the genetics of autism, brought together by the Autism Genome Project and the Autism Consortium.
While the funding will directly benefit UMMS researcher Michael Czech, it is also expected to be a boon for RXi Pharmaceuticals, which Czech co-founded, since the company holds an exclusive license to the delivery technology for therapeutic RNAi applications.