A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups

PanFAM-1 is 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. Specifically, the IMMray PanCan-d test uses
state of the art machine learning algorithms to condense the multiple fluorescence data
points generated by the test to a simple yes/no result. Thus, a highly complex statistical
model uses the multi-dimensional nature of the test to generate a score, which is called a
decision value. The score is compared to the established cut-off value for the test to inform
the operator whether the patient sample is positive or negative for PDAC. This study will
validate and evaluate the performance of the IMMray PanCan-d test in comparison to standard
of care imaging approaches that are currently used in PDAC disease surveillance. Subjects in
this study will be recruited from several European and North American research sites that
have a PDAC surveillance program or established protocol for monitoring individuals
considered to be at a high-risk for developing pancreatic cancer. Any subject that shows
disease progression while on-study will be removed from the study to receive standard of care
per institutional guidelines. Overall, this study poses minimal risk to subjects. The
PanFAM-1 study is an adaptive study design over two approximately 18 month intervals, which
are separated by an interim analysis to evaluate diagnostic accuracy of the IMMray PanCan-d
test. This study is an observational period in which blood collections from eligible subjects
will be evaluated using the IMMray PanCan-d test. Subjects will undergo scheduled imaging
assessment and clinical evaluation consistent with the resarch sites' PDAC surveillance
program. Subject data derived from the IMMray PanCan-d test during this portion of the study
will be delayed from time of initial blood collection until the samples are analyzed. The
analysis will compare IMMray PanCan-d test results for each subject to corresponding imaging
assessments performed as part of standard of care PDAC surveillance. The study will only
proceed to the interventional period if the interim analysis indicates that the diagnostic
accuracy of the IMMray PanCan-d test is capable of detecting PDAC in high-risk subjects with
the same or better ability as standard of care imaging. If at any time imaging assessments
are considered positive for clinical disease then, regardless of IMMray PanCan-d test
results, subjects will be managed according to institutional guidelines. All scheduled blood
collections for purposes of this study will be halted and subjects will be removed from the
study upon confirmation of PDAC.

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document

2. Individuals with the following family phenotype and age:

1. Two or more relatives with pancreatic adenocarcinomas (PDAC) on the same side of
the family, where 2 PDAC-affected individuals are first degree related (FDR) to
each other + at least 1 PDAC-affected individual is a FDR of the Participant (≥50
years old OR 10 years before onset)

2. Two affected FDR with PDAC (≥50 years old OR 10 years before onset)

3. Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely
pathogenic + 1 FDR or secondary degree related (SDR) with PDAC (≥50 years old OR
10 years before onset)

4. Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or
likely pathogenic mutation variants in: p16, CDKN2A (≥50 years old OR 10 years
before onset)

5. Known mutation carrier for STK11 (Peutz Jeghers Syndrome) (≥35 years old)

6. Lynch syndrome (HNPCC) with confirmed pathogenic or likely pathogenic variants
in: MLH1, MSH2, MSH6, PMS2, or EPCAM + 1 FDR or SDR with PDAC (≥50 years old OR
10 years before onset)

7. Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic
history of pancreatitis (≥40 years old OR 10 years before onset)

Exclusion Criteria: