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After missing the first-to-market opportunities with KRAS, both Merck KGaA and Amgen are strategically looking into additional gene markers, with the likely aim of being able to launch companion tests to their drugs that are more sensitive and accurate than the competition.

For Dx shops developing pharmacogenomic tests without big pharma's help, Medco says it can offer a better value proposition when it comes to driving adoption and reimbursement for their tests.

The boxed warning for Plavix's label alerts doctors that genetic tests are available to establish patients' CYP2C19 status. However, the FDA leaves it up to physicians to decide whether to wait for genetic testing results or put patients on an alternative treatment.

The study showed that alterations in the ABCB1 gene had no link to increased bleeding in patients treated with either Plavix or its competitor Effient, though patients treated with Plavix who were homozygous for a particular allele had an increased risk of cardiovascular death, heart attack, or stroke.

Research presented at the American College of Cardiology scientific session in Atlanta today suggests individuals who receive genetic testing early in their warfarin treatment are up to 31 percent less likely to be hospitalized than those who don't.

When Vectibix received approval from the US Food and Drug Administration in 2006, "Amgen already knew the response rate was low," according to an Amgen official. The company began collecting patient tissue samples from mid-2005 to early 2007, knowing it would "need those samples for a biomarker analysis."

"DxS is seeking to avoid its exclusive obligation with Roche because it no longer finds it advantageous to benefit from the Roche distribution network," but a termination of the agreement would cause "irreparable" harm, Roche stated in a recently filed complaint.

DxS denies allegations in a lawsuit filed by Roche last week that the UK-based diagnostics company is trying to renege on a distribution agreement between the two firms for KRAS and EGFR mutations tests.

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.

Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.

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The Atlantic reports another SARS-CoV-2 testing problem may be lurking: backlogs.

Researchers have sequenced the genome of "the Methuselah of freshwater fish."

The US Biomedical Advanced Research and Development Authority is supporting efforts to develop vaccines against SARS-CoV-2.

In Genome Biology this week: difference in methylation in neurons from Parkinson's disease patients, differential expression analysis by barcoded sequencing approach, and more.