The European Council formally approved another delay for the In Vitro Diagnostic Regulation implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.

The American Clinical Laboratory Association has followed through on its promise to file suit against the U.S. FDA over the agency’s final rule for lab-developed tests. The lawsuit will be heard in the U.S. District Court for the Eastern District of Texas, which is also the venue for litigation against another federal government agency, the Federal Trade Commission, suggesting that litigants expect a favorable review of their case in this court.

A little over two months after the granting of its very first patent which described computer-based systems for diagnosing psoriasis, Belletorus Corp. welcomed the publication of two continuation-in-part child filings on similar such systems for the diagnosis of eczema and determining the severity of skin diseases such as psoriasis, eczema and skin cancer.

Oncohost Ltd. provided new details on a novel application for its proteomic pattern analysis technology at Biomed Israel last week. While its initial development focused on using a single blood sample to guide selection of first-line immunotherapy for cancer based on likelihood of response, the Prophet platform now also predicts severe adverse immune-related events, Oncohost CEO Ofer Sharon told BioWorld.

Researchers affiliated with the U.K.’s University Hospitals Birmingham NHS Foundation Trust filed for protection of a device for treating simple or complex anal or rectovaginal fistulas which is less invasive and more effective than existing treatments. The device combines a bioresorbable scaffold to heal the fistula and a thin comfortable seton to achieve drainage.

“In an impressive eight-month timeline,” South Korea’s Lunit Inc. completed the $193 million (AU$292 million) acquisition of Volpara Health Technologies Ltd. to globally advance artificial intelligence (AI)-based cancer care.

The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.

At its investor presentation on May 22, Roche Diagnostics, a unit of Basel Switzerland-based Roche Holding AG reported on the company's pipeline plans, which include a slew of new tests, instrument upgrades, and the forthcoming launch of its fully automated mass spectrometry instrument.

In what represents the first PCT filing to be published in the name of Bayreuth, Germany-headquartered Incontalert GmbH, the company’s co-founders seek protection for a wearable device which employs machine learning techniques to non-invasively predict the bladder filling level for incontinence patients.

Liquid biopsy typically means blood testing, but several companies presenting at Biomed Israel May 21-23 have developed diagnostics that look to other, even less invasive options, and ever broader applications. Nevia Bio Ltd. is using vaginal secretions to detect ovarian cancer, while Early OM Ltd. and Nucleix Ltd. analyze urine for cancer biomarkers.