An AHRQ official provided updates on the agency's ongoing activities in the personalized medicine field, including the development of a BRCA testing decision-support tool; a draft report on frameworks for gauging genetic testing quality; and a randomized-controlled trial on pharmacogenomics warfarin dosing that is unlikely to change the standard of care.
Qiagen this week updated investors on how its recent spate of acquisitions, licensing agreements, and partnerships will drive organic growth in its sample preparation and PCR-based molecular diagnostics business.
A Novartis spokesperson told Pharmacogenomics Reporter last 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."
"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.
In the latter part of December, Clinical Data’s PGxHealth division inked a research collaboration with the German Heart Institute to “conduct one of the largest retrospective case/control studies to date to validate genetic variants associated with response” to Plavix. With this study, the partners hope to further inform the clinical utility of a pharmacogenetic test in determining best-responders to the anti-platelet agent.
The most widely read articles in Pharmacogenomics Reporter in 2009 included stories on the American Civil Liberties Union's lawsuit against Myriad Genetics and other patent holders of BRCA mutations; the US Food and Drug Administration's labeling updates to the anti-platelet agent Plavix, as well as the colorectal cancer drugs Erbitux and Vectibix; the growth of direct-to-consumer genomics services, such as 23andMe and Navigenics; Myriad's position on genetic counseling; and big pharma's reasons for investing in personalized medicine.
Clarient plans to commercialize Applied Genomics' five-antibody immunohistochemistry test for non-small cell lung cancer, called Pulmotype, within its network of pathologists by the first quarter of 2010.