Implementation of the Avantect Pancreatic Cancer Test in Newly Diagnosed Type 2 Diabetes Patients in a Clinical Setting

Pancreatic Cancer (PaC) is the 3rd leading cause of cancer mortality and is predicted to be the 2nd-leading cause by 2030. PaC and lacks effective early detection tools. Studies have identified patients with new-onset type II diabetes (diagnosis made ≤36 months; NOD) as a high-risk patient population that could benefit from early detection of PaC. ClearNote Health has validated a non-invasive, blood-based, epigenomic early-detection pancreatic test called Avantect. The test has been validated in a large case-control study, including patients with NOD. A pilot program to deploy the test in a clinical setting of NOD was conducted to assess the feasibility and integration of the test into a clinical workflow. Fifty patients received the Avantect test from ClearNote Health. Test results were delivered to the clinical site for post-test follow-up. Feedback on the clinical impact of the testing and logistics were reviewed at the conclusion of testing. The cohort consisted of 30 males (60%) and 20 females (40%). The average patient age was 68 years (range 38-87), and patients had an average time from diabetes diagnosis to testing of 22.9 months (range 1-36). A family history of PaC was observed in 29/50 patients (58%). Of the 50 total test orders, the required test blood volume of 10 mL was obtained in 45 patients (90%). These results included 43 patients with no abnormal signal detected (95.6%), and two patients with an abnormal signal detected (4.4%). The two abnormal signal-detected results are awaiting further clinical evaluation. These results demonstrate early success in the delivery of the Avantect test to the clinical practice of diabetic patients. The test is tailored to facilitate clinical implementation because of its non-invasive nature and its high-performance characteristics (sensitivity - 66.7%; sensitivity- 96.9%). Disclosure S. Chowdhury: Employee; ClearNote Health. D. Haan: Employee; ClearNote Health. W. Volkmuth: Employee; ClearNote Health. S. Levy: Employee; ClearNote Health. A. Vilalta: Consultant; ClearNote Health. M. Collins: Employee; ClearNote Health. M. Riviere: Employee; ClearNote Health. V. Lopez: Employee; ClearNote Health. A. Leighton: Employee; ClearNote Health. M. Antony: Employee; ClearNote Health. E. Nilson: Employee; ClearNote Health. A. Bergamaschi: Employee; ClearNote Health.