An AI-based software developed by Screenpoint Medical BV could help detect breast cancers earlier and reduce the number of cancers that appear between routine screenings. In a trial of over 100,000 women, the use of the company’s Transpara Detection system resulted in a 12% reduction in the rate of interval cancers, compared to standard mammography screening. The results from the Mammography Screening with Artificial Intelligence study was published in the Lancet.
Australian respiratory imaging technology company 4dmedical Ltd. raised AU$150 million (US$105 million) in an institutional placement to accelerate U.S. adoption of its CT:VQ lung imaging software to bolster the company’s lead in software-based lung imaging.
En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.
A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the U.S. Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several recent examples of this kind of fraud.
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes. Detailed in Cell Host & Microbe on Nov. 12, 2025, the database is expected to serve as a universal platform for academia and enable “precision microbiome medicine” for the industry, Lee told BioWorld.
Grail LLC has presented data showing that when added to standard screening procedures for breast, cervical, colorectal and lung cancers, its Galleri circulating tumor DNA test led to a sevenfold increase in the number of cancers detected.
A team of U.S. and South Korean researchers have developed an AI model called MSI-SEER that can not only predict microsatellite instability-high (MSI-H) tumors based on tissue slides, but also flag “what it does not know.” “Have you ever asked ChatGPT anything, and the response was, ‘I don’t know?’” Cheong Jae-ho asked during an interview with BioWorld. “Probably not, and that is the problem with AI now.”
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
Deep learning tools for protein design can also be used to create molecules that bind to them. Certain peptides, such as intrinsically disordered proteins (IDPs), are challenging to target due to their variable nature. However, scientists from the lab of Nobel laureate David Baker have developed a method to generate binders for IDPs by searching the world’s largest protein database with their AI-powered tool RFdiffusion.
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