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BioArray News Coverage of FDA and Microarrays

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  • Roche and Two Others Suggest a New Class of ASR: In Vitro Analytical Tests [BN, 8/6/2003]
  • OIVD’s Steve Gutman Says FDA Plans to Consider Changing ASR Regulations [BN, 7/23/2003]
  • Microarray Industry Keeps an Eye on FDA’s Approach to Roche AmpliChip [BN 7/16/2003]
  • FDA’s Weida Tong Discusses Tracking of Toxicology Microarray Data [BN 7/16/2003]
  • BREAKING NEWS: FDA to Roche: Your Presence is Requested. Agency Letter Seeks to Discuss AmpliChip [BN 7/10/2003]
  • FDA Conducting Two Test Projects to Get Better Acquainted with Microarray Data [BN 6/25/2003]
  • FDA Gates Swinging Open To Admit Standardized Gene Expression Data [BN 6/18/2003]
  • CDER’s Woodcock: FDA To Publish Draft Guidance in August on Array Data in INDs [BN 6/4/2003]
  • Expertech’s David Link on the FDA, In Vitro Diagnostic Regulations [BN 6/4/2003]
  • New FDA Draft Guidance for IVD is First For Industry in More Ways Than One [BN 5/28/2003]
  • Roche Reshapes Affy’s GeneChip As AmpliChip: Readies a CYP450 ASR [BN 4/25/2003]
  • FDA Testing of Iconix DataMatrix Is Another Step Forward for Microarrays [BN 3/21/2003]
  • FDA Preparing Draft Document to Help Guide Microarray Data Consideration [BN 3/14/2003]
  • The Scan

    Y Chromosome Study Reveals Details on Timing of Human Settlement in Americas

    A Y chromosome-based analysis suggests South America may have first been settled more than 18,000 years ago, according to a new PLOS One study.

    New Insights Into TP53-Driven Cancer

    Researchers examine in Nature how TP53 mutations arise and spark tumor development.

    Mapping Single-Cell Genomic, Transcriptomic Landscapes of Colorectal Cancer

    In Genome Medicine, researchers present a map of single-cell genomic and transcriptomic landscapes of primary and metastatic colorectal cancer.

    Expanded Genetic Testing Uncovers Hereditary Cancer Risk in Significant Subset of Cancer Patients

    In Genome Medicine, researchers found pathogenic or likely pathogenic hereditary cancer risk variants in close to 17 percent of the 17,523 patients profiled with expanded germline genetic testing.