NEW YORK (GenomeWeb) — Researchers at Johns Hopkins University have performed the first validation of the Cepheid Xpert Flu assay in a population of emergency room patients with acute undifferentiated respiratory illness.
NEW YORK (GenomeWeb) — IntelligentMDx (IMDx) said today that the artus GBS QS-RGQ kit, developed in partnership with Qiagen, has received CE marking for use with Qiagen's QIAsymphony SP/AS and Rotor-Gene Q instruments.
NEW YORK (GenomeWeb) — Qiagen has achieved a major milestone in its efforts to expand uptake of its QIAsymphony RGQ molecular diagnostics system, as the company disclosed this week that the platform recently received 510(k) clearance from the US Food and Drug Administration.
NEW YORK (GenomeWeb) — Qiagen has received 510(k) clearance from the US Food and Drug Administration for its QIAsymphony RGQ MDx system and Artus C. difficile QS-RGQ MDx kit, the company said Monday after the close of the market.
NEW YORK (GenomeWeb News) – A new company spun out of the National University of Singapore (NUS) launched today with a technology that it said can instantly provide a diagnosis for gastric and esophageal cancers during endoscopy.
Quest Diagnostics said this week that its Focus Diagnostics business has received expedited 510(k) clearance from the US Food and Drug Administration and CLIA moderate complexity categorization for its Simplexa HSV 1&2 Direct molecular test o
NEW YORK (GenomeWeb News) — IMDx said today that its IMDx VanR assay for the Abbott m2000 platform has received regulatory clearance from Health Canada and Singapore's Health Sciences Authority, allowing the test to be sold and distributed in those countries.
Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.