How PancraGEN Works

PancraGEN is a cutting edge, proprietary integrated molecular pathology test that assesses the cumulative DNA mutations in key oncogenes and tumor suppressor genes associated with pancreatic cancer. PancraGEN can help assess risk of malignancy in patients with cysts and enhance your diagnostic tools such as EUS imaging, CEA, Cytology and other risk factors by providing more information for use in management decisions.

PancraGEN Identifies:

  • Quality and Quantity of DNA in cyst fluid
    High levels of intact DNA are associated with actively dividing cells

  • Oncogenes
    KRAS and GNAS point mutations

  • Tumor Suppressor Genes

    Details

    Loss of Heterozygosity (Associated Tumor Suppressor Genes)

    Associated GenesGenomic Loci
    VHL, OGG13p
    PTEN, MXI110q
    TP5317p
    SMAD4, DCC18q
    CDKN2A, CDKN2B9p
    RNF43, NME117q
    PSEN2, TFF121q
    RUNX3, CMM1, LMYC1p
    MCC, APC5q
    NF222q

Specimen Types:

  • Aspirated pancreatic cyst fluid

Pancreatic Cyst Dilemmas:
From Guidelines to Molecular Markers

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Diagnostic Markers

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The Report

The PancraGEN report includes:

Biological Behavior

The report categorizes patients into four groups according to their risk of cancer (Benign, Statistically Indolent, Statistically Higher Risk, or Aggressive) and provides either the probability of benign disease over 3 years or the probability of High Grade Dysplasia/carcinoma.

Low Risk Supports Surveillance
BenignStatistically Indolent (SI)
97% probability of benign disease over the next 3 years. Patient lacks significant molecular alterations97% probability of benign disease over the next 3 years. Patient has significant molecular alteration but lacks concerning clinical features.
High Risk Supports Intervention
Statistically Higher Risk (SHR)Aggressive
65% probability of HGD/carcinoma
Patient has significant molecular alteration accompanied by concerning clinical feature(s)		91% probability of HGD/carcinoma
Patient has multiple significant DNA abnormalities

Molecular & Clinical Results

This section lists the molecular results generated and reported by Interpace Diagnostics. This section also includes test and clinical information provided to Interpace Diagnostics by the submitting physician.

Details

This section includes an in-depth review of the findings: molecular data, an explanation of why a particular diagnostic category was selected, details on the integration of clinical information, and the pathologist’s interpretation of the results.

Molecular Alterations Tested

This section provides an explanation of the importance of DNA quality and quantity. A listing of the oncogenes and tumor suppressor genes tested, along with their implications for pancreatic cancer, is also provided within this section.

Test Algorithm

This section provides an overview of the interpretive components used by the PancraGEN test in determining the biological behavior of pancreatic cysts.

Risk Stratification

Data from the National Pancreatic Cyst Registry study shows:

  • “Benign” or “Statistically Indolent” patients have a 97% probability of benign disease over the next 3 years
  • “Statistically Higher Risk” patients have a 65% probability of High Grade Dysplasia/carcinoma
  • “Aggressive” patients have a 91% probability of High Grade Dysplasia/carcinoma

Limitations and Disclaimers1

Although PancraGEN is highly specific for malignancy, some malignant cysts may not be detected. There may also be individuals who are falsely identified as having a malignant cyst. Diagnosis and appropriate patient management are the responsibility of the referring physician or healthcare provider.

References

  1. Al-Haddad MA, Kowalski T, Siddiqui A, et al. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015;47(2):136-146.
  2. V. Chernyak et al, Incidental pancreatic cystic lesions Radiology 2015 274 161-9
  3. BU Wu, et al, Prediction of malignancy in cystic neoplasms of the pancreas: a population based cohort study, Am J Gastro 2014 109 121-9
  4. Loren D, Kowalski T, Siddiqui A, et al. Influence of integrated molecular pathology test results on real-world management decisions for patients with pancreatic cysts: analysis of data from a national registry cohort. Diagnostic Pathology. 2016;11:5. doi:10.1186/s13000-016-0462-x.
  5. Gaujoux S., , Brennan, M., et al. Cystic Lesions of the Pancreas: Changes in the Presentation and Management of 1,424 Patients at a Single Institution over a 15-year Time Period. J Am Coll Surg. 2011 April; 212(4): doi:10.1016/j.jamcollsurg.2011.01.016.
  6. Kaimalkliotis, P., Riff, B., et al. Sendai and Fukuoka Consensus Guidelines Identify Advanced Neoplasia in Patients With Suspected Mucinous Cystic Neoplasms of the Pancreas. Clinical Gastroenterology and Hepatology 2015;13:1808–1815: doi:10.1016/j.cgh.2015.03.017
  7. Kushnir VM, Mullady DK, Das K, et al. J Clin Gastroenterol. 2019;53(9):686-692. DOI: 10.1097/MCG.0000000000001118.
  8. Gonda TA, Viterbo D, Gausman V, et al. Clin Gastroenterol Hepatol. 2017;15:913-919.
  9. Data on File.