The Power of PancraGEN®

Added Clarity

PancraGEN is a personalized molecular pathology test, that interrogates cumulative oncogene and tumor suppressor gene damage, reporting results in the context of each patient’s clinical history, imaging, fluid chemistry and cytology test results. Offering added clarity about the biologic behavior of a pancreatic cyst, PancraGEN provides an overall prognostic assessment that helps inform the best step forward when determining which patients are suited for surveillance vs. surgical intervention.

Gain Powerful Insight for Better Long-term Management

Overseen by expert molecular pathologists who have examined DNA aberrations in >56,000 pancreatic cyst patients, PancraGEN’s ability to accurately inform patient management decisions is also supported by long-term follow-up patient outcomes data (up to 8 years). Results provide deep insight into appropriate surveillance intervals or surgical approaches. Allowing you to more confidently manage patients over time, often with less aggressive treatment pathways.

Pancreatic Cyst Dilemmas:
From Guidelines to Molecular Markers

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Incremental Value of DNA Analysis

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Proven Accuracy

Long-term follow-up outcomes data of patients (up to 8 years) from the National Pancreatic Cyst Registry supports PancraGEN’s ability to help accurately inform surgery and surveillance decisions of patients.

In a study of the National Pancreatic Cyst Registry, PancraGEN’s recommendation of surveillance was correct in 97% of patients. In fact, PancraGEN diagnoses were more beneficial to overall patient outcomes than sole reliance on International Consensus Guidelines (ICG) criteria.1,4

PancraGEN has been performed on over 56,000 patients with pancreatic cysts, representing a full spectrum of pancreatic cyst patients with diverse clinical and molecular findings.

Easy Integration

Streamline your diagnostic practice with our Point2™ Fluid Chemistry Testing.  All Point2™ assays are highly accurate and have been specifically developed for use with pancreatic cyst fluid.

Point2™ Fluid Chemistry assays are available for CEA†, amylase, and glucose.  Additionally, each assay only requires a small amount of cyst fluid (0.2ml)*, even if the sample is viscous or bloody.9 They can be used independently or in conjunction with the PancraGEN molecular test.

Additional convenience of having easy-to-read results delivered through a secure, online physician portal.

Fluid chemistry results should be reviewed in relation to the patient’s medical history and current conditions.

*0.2mL is the lower limit of cyst fluid needed for testing. Providing additional cyst fluid volume, as possible, is encouraged. Specimens submitted that do not meet volume requirements will be tested using a dilution protocol or the ordering physician may be contacted for testing priority.

†Point2™CEA was previously AccuCEA™.

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.