Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients.
Australia’s Speedx Pty Ltd. is launching a new rapid polymerase chain reaction (qPCR) test for 14 different respiratory viruses in a single test that works on almost every commercial PCR platform in half the time and at a fraction of the cost of what its competitors charge.
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
The U.S. biopharma and med-tech industries are adding their voice to that of Gilead Sciences Inc. in urging the California Supreme Court to review the Gilead Tenofovir Cases, which seek to hold the drug company liable for how and when it developed its pipeline of HIV drugs.
Noze Inc. is hot on the trail of tuberculosis with its Diagnoze hand-held system that can detect the disease by its smell. The company, formerly known as Stratuscent, received additional support from the Bill & Melinda Gates Foundation to fund a study evaluating a breathalyzer designed to detect tuberculosis in high-burden countries.
Scientists at the Weizmann Institute of Science in Israel announced the discovery of the new intestinal microbiota species Kazachstania weizmannii in mice, which competed with and limited the growth of Candida albicans, thus preventing candidiasis. Both microorganisms belong to the Saccharomycetaceae family and reside in humans, maintaining a complex interaction with therapeutic value.
Researchers from the University of Stellenbosch in South Africa are seeking protection for a simple and user-friendly point-of-care device for diagnosing tuberculosis. Their electrochemical lateral flow device merges lateral flow device technology and electrochemical device technology by using porous electrodes that are capable of transporting electrolytic liquid and fluid sample.
In a recent study led by Soman Abraham from Duke University, investigators observed that an increase in nociceptive sensory nerves in urinary tract biopsies from patients with recurrent urinary tract infections (rUTIs) was linked to elevated nerve growth factor (NGF) from monocytes and mast cells. This overgrowth of nerve cells appeared to cause lingering symptoms after rUTIs.
COVID-19 severity remains open to several questions. Researchers at the University of California Los Angeles (UCLA) have revealed how SARS-CoV-2 causes acute inflammation instead of the symptoms of a common cold. This effect could be initiated by the peptide fragments of the coronavirus released when the host eliminates the virus, which can form pro-inflammatory complexes that trigger an amplified immune response.
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