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Tag Archives: Put It on the Board —

Put It on the Board, 2/14

February 2014—When are genomic tests useful? IOM seeks answers: Collaboration among key stakeholders to set clear evidentiary standards is needed to determine the clinical utility of genome-based testing in cancer care, according to a wide variety of experts participating in an Institute of Medicine workshop. Between 1969 and 1989, genomic biomarkers were mentioned in fewer than 50,000 National Library of Medicine publications. But between 2000 and 2010, more than 250,000 articles mentioned biomarkers, said a December 2013 IOM report, “Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary.”

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Put It on the Board, 12/13

December 2013—Illumina in November received premarket clearance from the FDA for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.

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Put It on the Board, 11/13

November 2013—Myriad Genetics presented last month new clinical data from a study with myRisk Hereditary Cancer, a 25-gene hereditary cancer panel, that showed a 60 percent increase in mutations detected in cancer predisposition genes in patients with a prior history of colon cancer, polyps, or both. Myriad presented this study and data from four others at the Collaborative Group of the Americas on Inherited Colorectal Cancer Annual Meeting in Anaheim, Calif.

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Put It on the Board, 10/13

November 2013—LifeTech names TriCore an NGS Center of Excellence: TriCore Reference Laboratories and Life Technologies have signed an agreement to establish TriCore as a regional Next-Generation Sequencing Center of Excellence. The partnership is part of Life’s initiative to establish a global alliance composed of centers capable of running the most advanced NGS-based oncology panels for clinical research.

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Put It on the Board, 9/13

September 2013—FDA clears Vitek MS: BioMérieux has been granted FDA 510(k) de novo clearance for Vitek MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. To gain FDA clearance, BioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates.

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Put it On the Board, 7/13

July 2013—The FDA approved Abbott’s hepatitis C virus genotyping test for use in the United States. The RealTime HCV Genotype II test differentiates genotypes 1, 1a, 1b, 2, 3, 4, and 5 and is run on the automated m2000 platform. Gavin Cloherty, PhD, Abbott Molecular’s director of scientific affairs, told CAP TODAY the test has a 99.5 percent accuracy relative to sequencing and a greater than 99 percent discrimination of HCV genotype 1 subtype 1a versus 1b. Time to result for 22 samples and two controls, he said, is 5.25 hours, with 30 minutes hands-on time.

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Put it On the Board, 5/13

May 2013—Omnyx digital pathology OK’d for routine use in Canada, Europe; PCR platform, kit cleared for H7N9; CollabRx forms Pan Cancer molecular oncology editorial board; ‘Time for omic ancillary systems’; Thermo Fisher to acquire Life Tech; First next-generation sequencing assay for GE Healthcare; FDA clears BD Diagnostics’ C. diff assay; Foundation Medicine, Sloan-Kettering to co-develop test for hematologic cancers

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Put it On the Board, 4/13

April 2013—ACMG issues guidance on incidental findings: The American College of Medical Genetics and Genomics released last month its recommendations for reporting incidental findings in clinical exome and genome sequencing. An ACMG working group, working with 15 experts who served as external reviewers, specifies a set of disorders, the relevant associated genes, and certain categories of variants that should be reported, based on a consensus-driven assessment of clinical validity and utility.

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