A new bacteriophage-based rapid test has the potential to identify the specific pathogen causing a urinary tract infection (UTI) at the point of care, enabling targeted use of antibiotics.
The test uses naturally occurring phages identified as predators of Escherichia coli, Klebsiella and Enterococci that are genetically modified to make any bacterium they invade bioluminescent.
In a proof-of-concept study, researchers at ETH Zurich, Switzerland, were able to reliably detect the pathogenic bacteria in a urine sample in less than four hours. That compares to the 18 – 30 hours it takes to culture samples in a central lab and to identify a specific microbe using conventional diagnostics. Read More
The U.S. FDA unveiled a proposal to once again reshuffle its operations, this time with a greater degree of emphasis on the function of the Office of Regulatory Affairs (ORA). Tim Philips, a consultant with Gardner Law and a former member of the FDA, told BioWorld that while these changes will likely yield some useful efficiencies, they might also dilute some of the more useful interaction between industry and FDA, a loss that may be keenly felt when it comes to matters such as FDA inspections. Read More
Magentiq-Eye Ltd. received U.S. FDA 510(k) clearance for its Magentiq-Colo, an artificial intelligence (AI) gastrointestinal software system that helps detect lesions in real time during colonoscopy procedures. With the rate of colorectal cancer expected to increase steadily through the decade, the company hopes that Magentiq-Colo will offer the gastroenterology community and its patients a significant increase in the adenoma detection rate. Read More
The U.S. Army needed 10 months to award a contract following a July 2022 request for proposals for flow cytometry and other clinical lab equipment, but Beckman Coulter Inc., filed an appeal that protested the award to Sysmex America Inc., of Lincolnshire, Ill. Beckman Coulter argued that Sysmex should have been disqualified from the bidding for failing to provide a technically acceptable proposal, but the Government Accountability Office decreed that the company’s protest failed because it was not filed within the required 10 days post-award. Read More
Protein quality control research is “almost exclusively focused on heat shock proteins, which are ubiquitously present” up and down the evolutionary chain, Xiaolu Yang told BioWorld. But “for more sophisticated organisms, which we humans like to think we are, it’s a little odd that we still use the system that bacteria started with…. It seems like we should have something more. The TRIM system,” he added, “fills that gap.” Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alpenglow, Anuncia, Asep, Coreplus, Jenavalve, Peijia Medical, Quansys Biosciences, Safecoat Medical, Signify Health, Sitero. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton, Dickinson and Company, Etiometry, Sirius Medical, Terumo. Read More
