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More articles about Regulatory News & FDA Approvals

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.

The Center for Comparative Effectiveness Research in Cancer Genomics expects its first clinical trial, which is investigating the predictive value of Genomic Health's Oncotype Dx in node-positive breast cancer patients, to serve as a model for future comparative effectiveness studies looking at genomic technologies in cancer.

The newest authorization allows testing on 3M's molecular diagnostic system.

DTC personal genomics firms, such as 23andMe, "don't have a laboratory, but they do [genomic] interpretation," Penny Thompson, deputy director of CMS' Center for Medicaid and State Operations, said during a meeting of the HHS Secretary's Advisory Committee on Genetics, Health, and Society in Washington, DC, last week. "That doesn't fall under CLIA."

Nanosphere received FDA clearance for its influenza and respiratory virus test to run on its new Verigene SP System.

Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.

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The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.