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Although FDA is still practicing regulatory enforcement discretion for the majority of laboratory-developed tests, the agency will put in place mechanisms allowing voluntary reporting of adverse events and malfunctions associated with LDTs through its MedWatch system.

Pfizer and Qiagen have expanded their personalized medicine portfolio with an Rx/Dx collaboration in glioblastoma multiforme.

Clinical Data is planning to submit a new drug application to the US Food and Drug Administration for its investigational depression drug vilazodone in the current quarter. However, due to unfavorable Phase III results on a response biomarker, the company will not be submitting its NDA with a companion test.

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.

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

Millipore was warned by the agency in September about an e-mail promotion for certain products for H1N1 influenza detection.

Investigators will compare results from the FilmArray PCR test to results from conventional platforms, like viral culture and antibody tests, as well as to results from other molecular diagnostic technologies.

The FDA researchers will use the data access and analysis software in genomics, proteomics, and other projects.

Speaking at the Personalized Medicine World Conference this week, FDA's Elizabeth Mansfield acknowledged that "things are changing hugely" at the agency.

The newly formed PGx advisory group's goal "is to provide information on potentially actionable gene-drug pairs to study participants and in some cases their physicians, along with information regarding published findings relating to gene status and drug efficacy or adverse events."


An Associated Press report says China refrained from releasing the SARS-CoV-2 genome for more than a week in January, frustrating the World Health Organization.

The Lancet and the New England Journal of Medicine have issued expressions of concern regarding the data used in two COVID-19 papers, the New York Times reports. 

Researchers have sequenced the genome of the mayfly, garnering insight into how insects evolved wings, Science reports.

In Genome Research this week: gene expression in primate brain regions, inversions and breakpoint inverted repeats in the human genome, and more.