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Task force issues serrated polyposis recommendations; Abbott launches SimpleScreen CRC blood test; brelovitug meets phase 3 goal in hepatitis delta
THE SHORT READ
The U.S. Multi-Society Task Force on Colorectal Cancer on Sept. 30 published 11 recommendations on serrated polyposis syndrome, which the announcement described as the most common gastrointestinal polyp syndrome.
Abbott began U.S. sales of SimpleScreen CRC, a blood test for colorectal cancer screening approved by the Food and Drug Administration (FDA). Mirum Pharmaceuticals said brelovitug met the primary end point of a phase 3 trial in chronic hepatitis delta.
THE DETAILS
- Guidelines Sept 30, 2026The U.S. Multi-Society Task Force on Colorectal Cancer, which includes representatives of the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA) and the American Society for Gastrointestinal Endoscopy (ASGE), published a consensus document on serrated polyposis syndrome online Sept. 30 in the three societies' journals. Its 11 evidence-based recommendations address awareness and identification of the syndrome, diagnosis, surgical and endoscopic management, colorectal cancer risk, surveillance intervals and genetic risk assessment. Lead author Dr. Douglas K. Rex said the recommendations emphasize recognition of the syndrome, including tracking numbers of serrated polyps over multiple colonoscopies.Source: ASGE
- Business Sept 30, 2026Abbott launched SimpleScreen CRC, a colorectal cancer screening blood test for average-risk adults 45 and older, in the U.S. on Sept. 30. In the PREEMPT CRC study of more than 48,000 average-risk adults scheduled for screening colonoscopy, it showed 81.1% sensitivity for colorectal cancer, including 63.5% for stage I cancer; 13.7% sensitivity for advanced precancerous lesions; and 90.4% specificity for advanced colorectal neoplasia, the company said. Abbott said Medicare covers the test and a positive result should prompt timely colonoscopy. The test won Food and Drug Administration approval this summer and will compete with Guardant Health's Shield, MedTech Dive reported.Sources: Abbott, MedTech Dive
- Research Sept 28, 2026Mirum Pharmaceuticals said in topline results Sept. 28 that the phase 3 portion of AZURE-1 randomized 153 treatment-naive patients with chronic hepatitis delta 2:2:1 to brelovitug 300 mg weekly, 900 mg every four weeks or delayed treatment. At week 24, 56% in the 300 mg arm and 45% in the 900 mg arm reached the combined end point of virologic response and ALT normalization, versus 0% with delayed treatment (P < .0001 for both). Mirum said it expects to submit a biologics license application in the first half of 2027 and no hepatitis delta treatment is approved in the U.S.Source: Mirum Pharmaceuticals
- Research Sept 30, 2026Nature Medicine on Sept. 30 published a randomized phase 2b trial of intravenous zabilugene almadenorepvec (VCN-01), an oncolytic adenovirus, with gemcitabine and nab-paclitaxel versus chemotherapy alone in metastatic pancreatic cancer. Overall survival in the intent-to-treat and full analysis set populations was a primary end point, along with safety and tolerability. Median overall survival was 10.6 versus 8.6 months in the intent-to-treat population (hazard ratio 0.69, 95% CI 0.42 to 1.12, P = .196) and 10.8 versus 8.6 months in the full analysis set (hazard ratio 0.57, P = .055). Intent-to-treat progression-free survival was 5.6 versus 4.6 months (P = .046).Source: Nature Medicine