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VKORC1

The group said the recommendations aim to standardize and improve warfarin response genotyping assays.

The study, involving 322 patients from China, India, and Malaysia, is the largest randomized evaluation of warfarin PGx in Asian patients, the authors said.

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A new FDA draft guidance lays out the agency's thinking on what constitutes a companion diagnostic, as well as Rx/Dx situations in which it would accommodate the marketing of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

UK Royal Statistical Society is organizing a working group to develop guidelines for assessing COVID-19 tests, the Guardian reports.

The Washington Post reports that the White House chief of staff has asked the US Food and Drug Administration to justify the stricter standards it is seeking for a coronavirus vaccine.

President Donald Trump's "good genes" comment raises eugenics concerns, CNN reports.

In PLOS this week: genetic analysis of tremor condition, analysis of a West and Central African tree used in traditional medicine, and more.