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IMMray® PanCan-d Test Results

Immunovia, Inc. returns all results to the ordering physician via secure fax or online portal.

When communicating test results to patients, it is important to note that the IMMray PanCan-d test is not a definitive diagnosis for pancreatic cancer. It should be used to identify which patients would benefit from further imaging, including an endoscopic ultrasound. The test should be used as a diagnostic tool, and results should be added to other clinical findings to make a diagnosis of pancreatic cancer. It does not replace a physician’s clinical judgement.

What do the results mean?

HIGH-RISK SIGNATURE PRESENT

The sample was classified as “high risk” for pancreatic ductal adenocarcinoma (PDAC) based on analysis of 9 serum biomarkers, including CA19-9, using a pre-determined risk stratification algorithm (see details below).  While this assay is highly accurate, its results must be evaluated considering both clinical findings and the patient’s family and genetic history to reach optimal care decisions.

NEGATIVE for High-Risk Signature

The sample was classified as negative for pancreatic ductal adenocarcinoma (PDAC) based on analysis of 9 serum biomarkers, including CA19-9, using a pre-determined risk-stratification algorithm (see details below).  While this assay is highly accurate, its results must be evaluated considering both clinical findings and the patient’s family and genetic history to reach optimal care decisions.

BORDERLINE

The sample was classified as “borderline” for pancreatic ductal adenocarcinoma (PDAC) based on the analysis of 9 serum biomarkers, including CA19-9, using a pre-determined risk stratification algorithm (see details below).  The borderline finding indicates that this sample could not be assigned a positive or negative result with high confidence.  Sample quality was adequate for assay interpretation.  Retesting with a new sample may clarify the results for this patient.  Typically, less than 7% of samples analyzed yield a borderline IMMray PanCan-d result.

Test Description

Patient serum was analyzed using an antibody microarray to measure the concentration of 8 protein biomarkers and a separate CA19-9 assay.  These results were combined using a unique risk-stratification algorithm.  This approach has been shown to be highly predictive of the presence of PDAC in multiple large clinical studies, and the algorithm has been shown to correctly detect early stage PDAC (stages I and II) with 97% accuracy.  In this laboratory, IMMray PanCan-d showed 99% specificity and 89% sensitivity for early stage PDAC and 92% sensitivity for PDAC of all stages.

The IMMray PanCan-d test is intended to be a surveillance tool, and test results should be added to other clinical findings to make the diagnosis of pancreatic cancer. The test does not replace a physician’s clinical judgment and should not be used as a definitive tool for the diagnosis of PDAC.

Given the complexity of the anatomy and biology of pancreatic disease and the substantial risk and sequelae of its treatment, NCCN guidelines indicate that “Decisions about diagnostic management and resectability should involve multidisciplinary consultation at a high-volume center with use of appropriate imaging studies.”

Please note that the IMMray PanCan-d test does not detect immune responses related to pancreatic neuroendocrine tumors (PNETs).

While this test result has high accuracy and a high negative predictive value, its positive predictive value depends on the pretest likelihood that an individual has pancreatic cancer.  This means that in a group of high-risk individuals, the positive predictive value of this assay is relatively high, while in a low-risk population, its positive predictive value is substantially reduced.

 

IMMray PanCan-d Negative Predictive Value (NPV) and Positive Predictive Value (PPV)

Stage I+II PDAC All Stages
NPV 3% prevalence 99.7% 99.8%
PPV 3% Prevalence 73.4% 74.0%
NPV 1% Prevalence 99.9% 99.9%
PPV 1% Prevalence 47.3% 48.2%

 

References:

Mellby et al. Serum Biomarker Signature-Based Liquid Biopsy for Diagnosis of Early Pancreatic Adenocarcinoma, Journal of Clinical Oncology, 36(28):2887-2894, 2018.

Sandström Gerdtsson et al., A Multicenter Trial Defining a Serum Protein Signature Associated with Pancreatic Ductal Adenocarcinoma.  International Journal of Proteomics, Vol. 2015, 587250, 2015.

NCCN Clinical Practice Guidelines. Pancreatic Ductal Adenocarcinoma, Version 2.2017.

 

Note: This test was developed, and its performance characteristics determined by Immunovia, Inc.  It has not been cleared or approved by the US Food and Drug Administration.