FDA Clears Roche’s Cobas c 703 and ISE Neo Analytical Units
The FDA has cleared Roche’s cobas c 703 and cobas ISE neo, high-throughput analytical units designed to automate workflows and address staffing and capacity challenges.
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Search Results for: infectious diseases
FDA Grants CLIA Waiver for Rapid Test That Differentiates Bacterial and Non-Bacterial Respiratory Infections
The FDA has granted a CLIA waiver for FebriDx, enabling its use in over 300,000 U.S. point-of-care settings and potentially reaching 80 million patients annually, according to PHASE Scientific.
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Roche Launches Respiratory Pathogen Panel With Flexible Syndromic Testing for CE Markets
Roche has launched the cobas eplex RP3 panel for CE-markets, enabling simultaneous detection of up to 25 respiratory pathogens with customizable configurations, according to the company.
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Researchers Develop First DNA Aptamers That Bind Alzheimer’s Blood Biomarker Neurofilament Light Chain
The newly identified aptamers match antibody-level binding strength and could support the development of lower-cost, point-of-care blood tests for neurodegeneration.
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Breath Test Using Carbon Isotopes May Quickly Confirm Bacterial Infections
A proof-of-concept study shows that bacteria-metabolized molecules enriched with carbon-13 produce detectable exhaled CO2, enabling rapid infection identification with inexpensive infrared scanners.
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