Immunovia has announced results from the PanFAM-1 study, a prospective, multi-center, investigational study, designed to assess the performance of the IMMray PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations.
The IMMray 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, states the company.
“Sensitivity, however, could not be evaluated due to the low number of PDACs among study participants.”
“We aimed for more tangible results of the PanFAM-1 study, which are partly inconclusive due to a variety of factors related to the execution of the clinical trial compared with original study design. The PanFAM-1 clinical study was also impacted by the COVID pandemic, when many hospitals were closed for the routine surveillance or screening of patients, as many others in the industry have experienced,” says Philipp Mathieu, CEO and President of Immunovia AB.
The execution of the study was compromised by the following factors:
Analysis of the sensitivity of IMMray 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 studies 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, and failure to provide a quality/accuracy assessment of imaging results.