Latest roundup ยท
Pathologic response tracks five-year melanoma survival; urine RNA assay detects bladder cancer; FDA lists AI device guidance as priority
THE SHORT READ
A pooled analysis of 1,038 patients given neoadjuvant therapy for melanoma, published Oct. 1 in Nature Medicine, found five-year relapse-free survival of 92.7% after pathologic complete response to checkpoint inhibitors, versus 35.2% after nonresponse.
A second Nature Medicine study reported 95% sensitivity at 90% specificity for a urine cell-free RNA assay in localized bladder cancer, and the Food and Drug Administration (FDA) listed final guidance on artificial intelligence-enabled device software among its fiscal 2027 priorities.
THE DETAILS
- Research Oct 1, 2026The International Neoadjuvant Melanoma Consortium analyzed 1,038 patients from 26 international sites treated with neoadjuvant immune checkpoint inhibitors (735), BRAF and MEK inhibitors (119) or checkpoint inhibitors plus targeted therapy (184), in a pooled analysis published Oct. 1 in Nature Medicine. In checkpoint inhibitor-treated patients, pathologic complete response was associated with five-year relapse-free survival of 92.7% and overall survival of 98.4%, compared with 35.2% and 71.6% after pathologic nonresponse. The authors reported excellent survival with neoadjuvant checkpoint inhibitors, particularly in patients achieving major pathologic response, but poor survival with BRAF and MEK inhibitors.Source: Nature Medicine
- Research Oct 2, 2026Researchers reported in Nature Medicine on Oct. 2 that uRARE-seq, a urine cell-free RNA method applied to 683 urine samples from patients with cancer and controls, demonstrated 95% sensitivity at 90% specificity for detecting localized bladder cancer and outperformed urine tumor DNA analysis. From pretreatment urine of 114 patients, the team developed a biomarker predicting likelihood of response to BCG versus chemotherapy (area under the curve 0.93) that was strongly associated with risk of recurrence. The authors said prospective studies are needed to assess its clinical utility.Source: Nature Medicine
- FDA Oct 1, 2026The Center for Devices and Radiological Health of the Food and Drug Administration (FDA) posted its fiscal 2027 guidance lists Oct. 1. Its A-list of priority documents includes final guidance on marketing submissions and lifecycle management for artificial intelligence-enabled device software functions, issued in draft in January 2025, and final guidance on predetermined change control plans for medical devices. In digital pathology, Proscia said in August that its 510(k) clearance for the Concentriq AP-Dx primary diagnosis platform included such a plan, letting it add support for additional FDA-cleared scanners, image formats and displays without further 510(k) submissions.