Immunovia AB announced results from the PanFAM-1 study. The PanFAM-1 study is a prospective, multi-center, investigational study, designed to assess the performance of the IMMray(TM) PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. The IMMray(TM) PanCan-d test met its primary endpoint of test specificity comparable to imaging in the study.

Sensitivity, however, could not be evaluated due to the low number of PDACs among study participants. Analysis of the sensitivity of IMMray(TM) PanCan-d in the PanFAM-1 study was confounded by the unexpectedly low 0.2% prevalence of PDAC in the PanFAM-1 cohort, which was lower than the c.1% prevalence in this risk group observed in other studies1, 2 and was lower than the prevalence assumed in the study design. In addition, the execution of the study was compromised by the following factors: The COVID pandemic significantly impacted the recruitment and monitoring of patients, Insufficient number of serial blood draws and/or imaging for each patient; Failure to provide a quality/accuracy assessment of imaging results; Individuals enrolled in PDAC surveillance programs were planned to receive imaging and clinical evaluation at least once per year consistent with the study center's protocol (MRI, EUS or CT) and had a blood draw every 6 months.

As an observational study, blood samples were frozen and stored until the IMMray(TM) PanCan-d test was clinically validated. Samples were collected at 23 sites in the US (14) and Europe (9), with 3,457 blood samples collected from 1,255 participants between January 2016 and November 2021. Sites in the U.S. contributed over 2,300 blood samples from two third of the study participants, with a median observation period of 1-2 years.

The IMMray(TM) PanCan-d results for US participants were in line with those reported for the US PanFAM-1 subjects in the blind validation (88.8% negative, 9.5% borderline, and 1.7% positive) [Clinical and Translational Gastroenterology, 2022; doi.10.14309/ctg.0000000000000468]. Statistical comparison of specific imaging findings and IMMray(TM) PanCan-d results is ongoing to examine trends in IMMray(TM) PanCan-d results relative to specific germline mutations, family histories, and imaging findings at the direction of the Principal Investigators in this study. Independent analysis of the PanFAM-1 results was conducted by Biostatisticians at the Biostatistical and Epidemiological Data Analysis Center (BEDAC) at Boston University School of Public Health.