Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.

Dynamic Therapeutics Ltd. is looking to commercialize its U-Rhythm technology which it hopes will transform the way hormones are measured. U-Rhythm, a portable device which collects biochemical samples from the patient throughout the day, will significantly change the diagnosis and treatment of many diseases, Stafford Lightman, co-founder of Dynamic Therapeutics told BioWorld.

Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services.

Researchers from Tan Tock Seng Hospital presented data from a study investigating the utility of soluble suppressor of tumorigenicity-2 (sST2) as early prognostic biomarker of severe dengue.

In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.

Severe fever with thrombocytopenia syndrome (SFTS) is a tick-borne disease that results from an infection with the SFTS virus, with a case fatality rate of 6.1% to 21.8%. Identifying critically ill patients at the early stages is crucial for clinical management.

The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.

The U.S. FDA has posted the long-awaited final rule for lab-developed tests, which amends the draft rule in a few key respects, but Reps. Diana DeGette and Larry Buchson, once again voiced their opposition to the rule. DeGette and Bucshon acknowledged that congressional inaction has left the FDA with few choices, but called again for passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which they said is critical because “burdensome regulation of these medical products creates uncertainty in the future of innovation and patient care.”

In what represents just the third PCT filing to have been published in the name of Zurich, Switzerland-based Siva Health AG, protection is sought for a computer-implemented method of classifying an individual suffering from chronic cough.