TEST:

Pancreasure

''Immunovia AB...today announced new performance data for PancreaSure in support of its upcoming Medicare coverage application. The data represent the first evaluation of PancreaSure in symptomatic individuals at elevated risk of pancreatic cancer. A pooled analysis across two validation studies shows that PancreaSure detected Stage I and II pancreatic ductal adenocarcinoma in genetically or familial high-risk individuals with symptoms of pancreatic cancer with 83.3% sensitivity and 91.6% specificity. Performance was consistent across clinically important sub-groups, supporting the test's usability in its intended-use population.''

''Immunovia AB...today announced that the final results from the AFFIRM clinical study have been published in the Journal of Clinical Oncology: Oncology Advances. The results show 88% sensitivity and 98% specificity for PancreaSure in late-stage pancreatic cancer patients and healthy, average-risk individuals, respectively, consistent with previously reported interim data.''

''Immunovia AB...today announced the launch of ASSURE, a post-marketing registry evaluating the real-world clinical impact of its commercially available blood-based biomarker test, PancreaSure. The study is designed to capture clinical data on how PancreaSure influences clinician decision-making in pancreatic cancer surveillance. Data generated in ASSURE will support Immunovia's reimbursement efforts and clinician adoption of the test.''