Initial clinical results of the first commercial clinical blood test dedicated to the early detection of pancreatic ductal adenocarcinoma (PDAC).

Abstract

e16258 Background: The IMMray® PanCan-d blood test for early detection of PDAC has been commercially available in 45 U.S. states since the laboratory’s licensure in August 2021. This is the first clinically-available blood test dedicated to the early detection of PDAC, combining an 8-plex biomarker signature with CA19-9 in a proprietary algorithm. Here we report the initial results of this assay. Methods: All orders received and results reported were reviewed for the IMMray PanCan-d test between August 4, 2021 and February 11, 2022. Serum specimens were processed at the Immunovia, Inc. laboratory in Marlborough, Massachusetts. Demographic information of individuals undergoing testing is based on the completed test requisition submitted by their health care providers. All information was de-identified prior to this analysis. Results: The median age of those tested was 59 years and 46% were male. 76% of patients were referred because of a history of familial pancreatic cancer. Germline mutation prevalence is reported in the table below. 12% of patients had IPMNs or mucinous cystic neoplasms, 2% had chronic pancreatitis and 3% had new onset Diabetes Mellitus. Table. Demographics of Individuals Tested with the IMMray PanCan-d test 80.5% of IMMray PanCan-d results were negative, 1.1% were high-risk signature present, and 11.5% were borderline. These results are fully consistent with validation studies for this assay in high-risk surveillance populations (Brand RE et al Clin Transl Gastroenterol, doi: 10.14309/ctg.0000000000000468). 6.9% of individuals tested had a CA19-9 value of less than 2.5 U/ml, which we identify as presumptively Lewis null (le/le) and CA19-9 non-secretors. Given that CA19-9 contributes significantly to calculated decision values for the IMMray PanCan-d test, individuals with a CA19-9 less than 2.5 U/ml receive a result of test not performed. Conclusions: The commercial availability of a biomarker assay for the early detection of PDAC resulted in a testing population with demographics and referral criteria similar to that of PDAC high-risk surveillance programs in the U.S. IMMray PanCan-d test results were as expected based on prior validation studies.[Table: see text]