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More articles about Regulatory News & FDA Approvals

Agendia said that it is the fourth FDA clearance for MammaPrint over the past three years.

The molecular diagnostics company is preparing to commercialize a pancreatic cancer test.

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paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance.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.

A changing R&D paradigm fueled by the growing demand for personalized medicine is "one of the reasons that the pharmaceutical industry is facing rising taxes," a PricewaterhouseCoopers expert said. As a result, a PwC report released earlier this month advised pharma, biotech, and device firms to invest in tax planning early in their business strategic decisions.

The agency granted Emergency Use Authorization for the GeneSTAT diagnostic test.

The FDA cleared two assays with samples collected during women's routine liquid-based Pap testing for cervical cancer screening.

The company is seeking the CLIA waiver while it also pursues FDA clearance of the FilmArray and a respiratory panel designed to identify and detect 22 upper respiratory diseases.

At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.

The ProParaflu+ assay joins a line of tests Prodesse sells for diagnosing and differentiating respiratory viruses.

The FDA cleared an update to the package insert for its Verigene Respiratory Virus Nucleic Acid Test to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.

Enzo aims to market the ColonSentry test in NY and NJ.

Nanosphere is seeking FDA clearance for the assay, which would be used to provide early diagnosis of myocardial infarction and risk stratification for acute coronary syndromes.

Roche becomes the latest of a handful of vendors to get an EUA from the FDA to sell its 2009 H1N1 flu assay to CLIA labs.

In a draft paper, entitled "The NCCN Comparative Therapeutic Index as a Paradigm for Near-Term Comparative Effectiveness Analyses of Existing Data in Oncology," the NCCN said its methodologies for comparing the risk/benefit value of treatments "will not be in conflict with 'personalized medicine' as it pertains to the care of cancer patients."

The guidance document is intended to help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus, and provides information regarding filing for Emergency Use Authorization.

The FDA cleared the firm's microarray-based multiplex platform and a rheumatoid arthritis test that runs on the system.

Studies on genomically defined subpopulations that would advance personalized medicine are "going to get lost in the wash by considering everybody equivalent, which we know they are not," Collins said at a colloquium on personalized medicine hosted by the American Association for the Advancement of Science.

Comparative effectiveness research that analyzes the efficacy and safety of a particular treatment in a genomic subgroup "should address strengths and limitations of this evidence, how specific it is for patient subgroups, and evidence gaps that are priorities for further CER," the report states.

"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins said at a colloquium on personalized medicine hosted by AAAS.

The FDA cleared analytical reactivity information to be added to a package insert for the firm's RAMP Influenza A/B Assay.

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The Washington Post reports on researchers' efforts to determine the effect of an increasingly common SARS-CoV-2 mutation.

Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.

A new analysis finds a link between popular media coverage of a scientific study and how often that paper is cited.

In Nature this week: CRISPR approaches to editing plant genomes, way to speed up DNA-PAINT, and more.