Korean biotech Noul has signed an exclusive distribution agreement with Biomedica to introduce its AI-based cervical cancer diagnostic solution, miLab CER, in Europe. The platform automates the diagnostic process using liquid-based cytology slides. Initial sales will focus on six Eastern European countries before expanding across the continent.

Korean biotech Noul has signed an exclusive distribution agreement with Biomedica to introduce its AI-based cervical cancer diagnostic solution, miLab CER, in Europe. Initial sales will focus on six Eastern European countries before expanding across the continent.

Beacon Biosignals has raised $86 million in Series B funding to expand its neurodiagnostic dataset and advance the clinical use of AI-driven brain health biomarkers. The FDA-cleared Waveband device records brain activity during sleep and wakefulness.

Siemens Healthineers is considering divesting or spinning off its diagnostics division by 2030 following restructuring. There have been no talks yet with potential buyers, and the decision will depend on whether separating would be better for the division, CEO Bernd Montag said.

Labcorp has agreed to acquire non-emergent outreach laboratory service assets from Parkview Health. The deal will enable Labcorp to provide laboratory services to Parkview patients in Indiana and northwest Ohio, using both local and national resources.

A new test for Lyme disease, developed by Dartmouth Hitchcock Medical Center, uses droplet digital PCR to detect Borrelia burgdorferi with over 90% sensitivity. The technology can also differentiate between active and past infections.

Case Western Reserve University and Wayne State University have received a $1.7 million training grant from the NIH to educate researchers on the interplay between genetic and environmental factors in health. The program aims to bridge genetic epidemiology and exposure science, enhancing understanding of how environmental factors such as pollution affect health at a genetic level.

India's Biocon anticipates a 50% reduction in biosimilar development costs following a US proposal to ease clinical testing requirements. "You can do more because it's [the FDA's draft proposal] going to halve the cost of development ... you can develop them [biosimilars] and bring them to patients faster and make it more affordable," said CEO Shreehas Tambe of Biocon Biologics. The company, which derives over 60% of its revenue from biosimilars, plans to launch two more in the US in the next six months.

FDA leaders Marty Makary and Vinay Prasad have proposed a path to approve on-demand gene-editing medicines, allowing slightly different CRISPR editors for individual children as long as they target the same clinical syndrome and show consistent benefit, building on the recent success of the first custom editor used in a child and the emergence of "umbrella trial" frameworks that enroll patients with different mutations into a single study. The biggest obstacles include the regulatory requirements built for mass-scale medicines, the lack of rapid small-batch manufacturing needed for critically ill children and a sluggish for-profit sector needed to help scale access, writes Fyodor Urnov, director of the Innovative Genomics Institute at the University of California, Berkeley.

Delays in implementing the EU's in vitro diagnostic regulation are hindering innovation, said Dr. Sascha Wettmarshausen, head of regulatory affairs and quality at the German trade association Verband der Diagnostica-Industrie. Wettmarshausen pointed to systemic issues such as insufficient notified bodies and extensive bureaucracy.