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IMMray™ PanCan-d results published in Journal of Clinical Oncology

The prestigious Journal of Clinical Oncology (JCO) has published the results of the major retrospective clinical validation study performed by Scandinavian and US researchers, showing that the IMMray™ PanCan-d serum biomarker microarray detects early pancreatic cancer with 96% accuracy.

Link to the article in JCO: Mellby et al. Serum biomarker signature-based liquid biopsy for diagnosis of early-stage pancreatic cancer.

Flyer for download (Pdf).

Introduction

Pancreatic ductal adenocarcinoma (PDAC) has a very poor 5-year survival rate of less than 10%. By resecting more tumors when they are still confined to the pancreas, the overall 5-year PDAC patient survival rate would increase significantly. In an effort to achieve reliable early detection we have developed IMMray™ PanCan-d, a microarray-based blood test for diagnosis of PDAC patients.

Objective

The purpose of this study is to derive a novel biomarker signature of early-stage PDAC from a large patient cohort and to subsequently validate the derived biomarker signature in an independent study cohort.

Conclusions

  • PDAC stage I and II patients were detected with 96% accurcy* and validated with a distinct patient cohort.
  • PDAC stage I to IV patients were detected with 98% accuracy* and validated with a distinct patient cohort.
  • Chronic pancreatitis was discriminated from PDAC with an accuracy* of 84%.
  • Malignant IPMNs were correctly classified as PDAC.

Results

Click on image below for larger size.

Fig 1. Classification of pancreatic ductal carcinoma stages in the Scandinavian cohort, using biomarker signatures. The study covered 1331 serum samples of PDAC stages I to IV and matched healthy controls. Using data from the Scandinavian study, predictive models that were based on frozen support vector machine were built. Two biomarker signatures were defined, using the backward elimination algorithm, for classification of (A) normal control (NC) samples from pancreatic ductal adenocarcinoma (PDAC) stage I and II, and (B) PDAC stage III and IV, respectively. The results are presented as receiver operating characteristic curves and their corresponding area under the curve (AUC) values.

Click on image below for larger size.

Fig 2. Validation of the consensus signature in stage I and II pancreatic ductal carcinoma from the United States cohort. The study covered 362 serum samples of PDAC stages I to IV and matched healthy controls. The consensus signature generated from the Scandinavian cohort was validated in the independent cohort in the United States by classifying (A) normal controls (NC) v patients with pancreatic ductal adenocarcinoma (PDAC) stage I and II, and (B) patients with PDAC stage I and II v patients with chronic pancreatitis (CP). The results are presented as representative receiver operating characteristic curves and their corresponding area under the curve (AUC) values.

Methods
Antibody microarray slides are printed and incubated with biotinylated patient serum. Levels of bound antigens are detected by fluorescence scanning. State-of-the-art machine learning algorithms were employed in the development of the IMMray™ PanCan-d signature. Hundreds of analytes were thus reduced to generate a comprehensive signature capable of distinguishing PDAC from controls.

Click on image below for larger size.

Next steps

Based on these extremely encouraging results we have initiated prospective validation of IMMray™ PanCan-d microarray with the pancreatic cancer risk groups: PanFAM-1 for hereditary/familial, PanSYM-1 for vague/early symptoms and PanDIA-1 for new onset diabetics after 50 years of age.

References:

Mellby et al. Serum biomarker signature-based liquid biopsy for diagnosis of early-stage pancreatic cancer. J Clin Oncol. 2018 Aug 14. doi: 10.1200/JCO.2017.77.6658.

* A closer look at accuracy

The accuracy of a test depends on how well the test separates the group being tested into those with and without the disease in question. Accuracy is measured by the area under the ROC curve. An area of 1 represents a perfect test; an area of 0.5 represents a worthless test. A rough guide for classifying the accuracy of a diagnostic test is the traditional academic point system:
• 0.90-1 = excellent (A)
• 0.80-0.90 = good (B)
• 0.70-0.80 = fair (C)
• 0.60-0.70 = poor (D)
• 0.50-0.60 = fail (F)

Reference:

Area under the ROC curve http://gim.unmc.edu/dxtests/roc3.htm

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