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FDA Clears AutoGenomics' Infinity Analyzer

NEW YORK (GenomeWeb News) — AutoGenomics said today the US Food and Drug Administration has cleared its Infiniti Analyzer as a stand-alone instrument for multiplexed assays.
 
The FDA in February cleared AutoGenomics’ Infiniti Factor II and Factor V assays for diagnosing thrombophilia.
 
The company said it also has submitted a 510(k) application with the FDA for its Infiniti 2C9/VKORC1 multiplexed assay, which is used to assess sensitivity to the blood thinner warfarin.
The Scan

Follow-Up Data Requests to Biobank Participants Ineffective, Study Finds

An effort to recontact biobank enrollees for additional information reports low participation in a new BMJ Open study.

Study Finds Widespread Transmission of Resistant Bacteria in Vietnam Hospitals

A sequencing study in The Lancet Microbe finds widespread transmission of drug-resistant Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii in two Vietnam ICUs.

Novel Brain Cell Organoids Show Promise for Autism Research

University of Utah researchers report in Nature Communications on their development of brain cell organoids to study SHANK3-related autism.

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.