P0002 - The IMMray® PanCan-d Test Performance and CA19-9: Results From the Blind Validation Study

Sunday, October 24, 2021

3:30 PM – 7:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Award: Presidential Poster Award

Presenting Author(s)

Thomas C. King, MD, PhD

Immunovia, Inc.
Marlborough, MA, United States

Award: Presidential Poster Award

Thomas C. King, MD, PhD
Immunovia, Inc., Marlborough, MA

Introduction: The IMMray PanCan-d test combines an 8-plex biomarker signature with CA19-9 in a proprietary algorithm to detect pancreatic ductal adenocarcinoma (PDAC) in serum samples. This study aimed to validate the clinical performance of the IMMray PanCan-d test and to better understand test performance in Lewis null (le/le) individuals who do not express CA19-9.

Methods: Serum samples from 591 patients were analyzed with the IMMray PanCan-d biomarker signature and CA19-9 assay, including 167 PDAC samples (stage I – IV), 203 individuals at high-risk for familial/hereditary PDAC (enrolled in the PanFAM study Clinicaltrials.gov Identifier: NCT03693378, “high-risk individuals”), and 221 healthy controls. All samples were freshly collected through study collaborators at eleven reference sites in the U.S. and Europe. The study was performed by Immunovia, Inc. in Marlborough, MA and sample identity was blinded to all laboratory staff throughout the study.

Test results were automatically generated, using validated custom software with locked model algorithms and predefined decision value cutoffs for sample classification. Data was uploaded automatically to Orchard Harvest Laboratory Information System before sample identity was un-blinded to enable calculation of the clinical test performance in terms of sensitivity and specificity.

Results: The IMMray PanCan-d test was able to distinguish PDAC stages I & II (n=56) vs high-risk individuals with 98% specificity and 85% sensitivity and distinguished PDAC stages I – IV vs high-risk individuals with 98% specificity and 87% sensitivity. Very similar results were demonstrated in PDAC vs healthy controls, with 99% specificity and 85% sensitivity in detecting stage I & II PDAC.

Based on available research, we identified samples with a CA19-9 value of 2.5 U/ml or less as probable Lewis null (le/le) individuals. Excluding these from the analysis removed 55 samples and increased the IMMray PanCan-d test sensitivity to 92% for PDAC stages I – IV (n=157) vs healthy (n=192) and high-risk familial/hereditary patients (n=187). Sensitivity for PDAC stage I & II increased to 89% with 99% specificity.

Discussion: These results demonstrate the IMMray PanCan-d blood test can detect PDAC with high specificity (99%) and sensitivity (92%).

		All Samples			CA19-9 <2.5 excluded
PDAC vs PanFAM	Stage I+II		All Stages	Stage I+II		All Stages
Sensitivity	85.0%		86.8%	89.0%		92.0%
Specificity	99.0%		98.4%	99.0%		99.0%
NPV 3% prevalence	99.5%		99.6%	99.7%		99.8%
PPV 3% prevalence	62.1%		62.7%	73.4%		74.0%
NPV 1% prevalence	99.8%		99.9%	99.9%		99.9%
PPV 1% prevalence	34.9%		35.4%	47.3%		48.2%

Disclosures:

Thomas King: Immunovia, Inc. – Employee.

Thomas C. King, MD, PhD. P0002 - The IMMray® PanCan-d Test Performance and CA19-9: Results From the Blind Validation Study, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.