VKORC1 | GenomeWeb

VKORC1

The large PGx analysis might provide welcome data for those already supportive of genotyping in the context of warfarin, but will it convince detractors?

NEW YORK (GenomeWeb) – A new project spearheaded by Genome British Columbia and the BC Pharmacy Association (BCPhA) aims to assess whether pharmacists can drive adoption of genetic testing among doctors and help provide patients greater access to personalized medicine.

Originally published Nov. 22.
Doctors have been in a "should we or shouldn't we" conundrum with warfarin pharmacogenetic testing for years.

A new FDA draft guidance lays out the agency's thinking on what constitutes a companion diagnostic, as well as Rx/Dx situations in which it would accommodate the marketing of unapproved tests.

According to the agency, ParagonDx's ASR probes for gauging the presence of CYP2C9*2, CYP2C9*3, VKORC1 1173, VKORC1 3730 variants "are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body."

The FDA updated the labeling for warfarin on Jan. 22 to include PGx-guided dosing ranges. FDA's Lesko explained that the labeling provides dosing ranges in order to give doctors the flexibility to consider their patients clinical factors when determining the appropriate maintenance dose of the anticoagulant.

Biomedical research projects are generating a ton of data that still needs to be analyzed, NPR reports.

Theranos is retiring some of its board members, including Henry Kissinger and George Shultz, Business Insider reports.

The heads of 29 scientific societies and some 2,300 researchers call on President-elect Donald Trump to rely on and support science in two separate letters.

In Science this week: genetically modified flu virus could be key to new live vaccines, and more.