For more than a decade, HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the regulatory greenlight for patients to swab themselves in the privacy of their own homes in recent years. With STIs reaching levels not seen in decades, regulators and physicians hope that the move will increase diagnostic rates and reduce disease spread by overcoming stigma and access barriers.

As investors and industry alike try to read the tea leaves of what the upcoming change in administrations holds for the U.S., speculation abounds about what Trump 2.0 will mean for the biopharma and med-tech spaces.

When every hour’s delay in treatment increases the risk of death 8%, dialing down time to diagnosis takes on acute urgency for clinicians and regulators. When the disease being treated kills 20% of the global population and 33% of hospitalized patients in the U.S., the market opportunity attracts investors. And when the technology makes breakthroughs possible that cut the time to targeted treatment from days to hours or even minutes, the number of products in development explodes, as the keen competition in sepsis diagnostics covered by BioWorld in 2024 demonstrates.

As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.

Labcorp Holdings Inc. launched its new H5N1 bird flu molecular test for humans in the U.S. as an international outbreak of the disease continues to spread in cows and poultry – and people. As BioWorld reported recently, just one mutation would make the flu variant highly transmissible in humans.

Although it does not generally infect humans, a single mutation of the H5N1 virus in the highly pathogenic avian and bovine clade 2.3.4.4b could overcome this barrier and possibly trigger a pandemic. Scientists at The Scripps Research Institute have warned of this possibility after studying the three-dimensional structure of the viral hemagglutinin and seeing how a change in one amino acid would make it more suitable for the human cell receptor. The researchers stress the need to monitor new mutations of this virus in order to act quickly in case the global jump to our species occurs.

After raising AU$7 million (US$4.5 million) in is initial public offering on the Australian Securities Exchange last week, Renerve Ltd. is already exploring mainland China for its portfolio of nerve repair and regeneration products.

In what represents the first patenting from Glasgow-based Microplate Dx Ltd., three of its co-founders describe a system for diagnosing microbial infections and performing rapid antimicrobial susceptibility testing, enabling quicker and more precise determination of effective antibiotics.

Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.