A Novartis spokesperson told Pharmacogenomics Reporter this week that the company "plans to have discussions with the FDA about the specific requirements for the approval of lumiracoxib when used in conjunction with a biomarker program."

Although CMS does not have a national coverage determination on pharmacogenomic testing in cancer, a CMS advisory committee met last week in Baltimore, Md., to discuss whether five tests are clinically useful in the Medicare population.

Already a pioneer in incorporating pharmacogenetic testing into its PBM programs, Medco's decision to buy DNA Direct signals its intent to be a "one-stop shop" for payors and employers interested in using genetically guided medicine to make healthcare more efficient and lower costs.

Duke researchers and the SAEC will use whole-genome sequencing to identify and validate rare gene variants associated with clozapine-induced immunological response.

Oncotype DX for colorectal cancer recurrence in stage II patients may have just launched, but Genomic Health is already working to expand the test's indication into later stages of the disease. Also, the company is not giving up on the predictive indication of the test.

"Our data reinforce the importance of the KRAS mutation as a predictive biomarker for responsiveness to Vectibix therapy," said Roger Perlmutter, Amgen's executive vice president of research and development.