Research & Development
DCN Dx acquires Biomed Diagnostics
The purchase expands DCN Dx's reach into the point-of-use testing and sampling market by adding a number of tests to its portfolio, including InPouch TV for detection of Trichomonas vaginalis, Transport Media (VTM) for SARS-CoV-2 sample transport, and InTray VS COLOREX for testing for methicillin-resistant Staphylococcus aureus (MRSA).
April 24, 2022
Labcorp launches smart laboratory test reports
The reports are available for diseases that have significant health risks on their own or as co-morbidities for other conditions, such as diabetes and chronic kidney disease. Labcorp has also created reports for conditions that impact hospitalizations, such as community-acquired methicillin-resistant Staphylococcus aureus (MRSA).
July 8, 2020
FDA clears Roche's novel MRSA nasal swab test
The agency cleared the cobas vivoDx MRSA test through the de novo premarket review pathway. Along with the Roche authorization, the FDA established special controls for these types of diagnostics, including requirements related to labeling and design verification and validation to address certain risks, such as false positives. The FDA's action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may apply through the 510(k) pathway.
December 4, 2019
Luminex MRSA test clears FDA
The Aries MRSA assay tests directly for MRSA DNA from nasal swabs in patients at risk for nasal colonization. Clearance was granted on September 25 and announced by the company on October 1.
September 30, 2019
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
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