Evidence
- Farrell JJ, Al-Haddad MA, Jackson SA, Gonda TA. Incremental value of DNA analysis in pancreatic cysts stratified by clinical risk factors. Gastrointest Endosc. 2019;89:832-841. doi: 10.1016/j.gie.2018.10.049.
- Kowalski T, Siddiqui A, et al. Management of Patients With Pancreatic Cysts: Analysis of Possible False-Negative Cases of Malignancy. J Clin Gastroenterol. 2016 Sep;50(8):649-57. doi: 10.1097/MCG.0000000000000577.
- 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.
- Al-Haddad MA, Kowalski T, Siddiqui A, et al. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015; 47:136-146. doi:10.1055/s-0034-1390742
- Ananya Das, William Brugge, et al. Managing incidental pancreatic cystic neoplasms with integrated molecular pathology is a cost-effective strategy. Endosc Int Open 2015; 03(05): E479-E486. DOI: 10.1055/s-0034-1392016
- Finkelstein, S. D., Bibbo, M. et al, Mutational Analysis of Cytocentrifugation Supernatant Fluid From Pancreatic Solid Mass Lesions. Diagn. Cytopathol 2014; 42: 719–725. doi: 10.1002/dc.23048
- Deftereos, G., Finkelstein S.D., et al. The value of mutational profiling of the cytocentrifugation supernatant fluid from fine-needle aspiration of pancreatic solid mass lesions Mod Pathol. 2014; 594-601. doi: 10.1038/modpathol.2013.147.
- Jonathan S. Kung, Oscar A. Lopez, Erin E. McCoy, Sofiya Reicher, Viktor E. Eysselein Fluid Genetic Analyses Predict the Biological Behavior of Pancreatic Cysts: Three-year Experience JOP. 2014; 427–432. doi: 10.6092/1590-8577/2426.
- Malhotra, N., Jackson, S., et al. The added value of using mutational profiling in addition to cytology in diagnosing aggressive pancreaticobiliary disease: review of clinical cases at a single center BMC Gastroenterology 2014; 14:135. doi: 10.1186/1471-230X-14-135
- Wu J., Jiao Y., et al. Whole-exome sequencing of neoplastic cysts of the pancreas reveals recurrent mutations in components of ubiquitin-dependent pathways Proc Natl Acad Sci U S A. 2011; 108(52):21188-93. doi: 10.1073/pnas.1118046108.
- Mertz, H. K-ras mutations correlate with atypical cytology and elevated CEA levels in pancreatic cystic neoplasms Dig Dis Sci. 2011; 56(7):2197-201. doi: 10.1007/s10620-010-1556-z.
- Wu J., Matthaei H., et al. Recurrent GNAS mutations define an unexpected pathway for pancreatic cyst development. Sci Transl Med 2011; 3(92): 92ra66. doi: 10.1126/scitranslmed.3002543.
- Nagula S, Kennedy T, et al. Evaluation of cyst fluid CEA analysis in the diagnosis of mucinous cysts of the pancreas. J Gastrointest Surg. 2010; 14(12):1997-2003. doi: 10.1007/s11605-010-1281-0.
- Toll AD., Kowalski T., Loren D., Bibbo M. The added value of molecular testing in small pancreatic cysts. JOP 2010 Nov 9;11(6):582-6.
- Pitman, M. B., Lewandrowski, K., et al. Pancreatic cysts: preoperative diagnosis and clinical management. Cancer Cytopathol 2010;118(1):1-13. doi: 10.1002/cncy.20059.
- Khalid, A., Zahid, M., et al. Pancreatic cyst fluid DNA analysis in evaluating pancreatic cysts: a report of the PANDA study. Gastrointest Endosc. 2009: 69(6):1095-102. doi: 10.1016/j.gie.2008.07.033.
- Shen, J., Brugge, W.R., et al. Molecular analysis of pancreatic cyst fluid: a comparative analysis with current practice of diagnosis. Cancer. 2009; 117(3):217-27. doi: 10.1002/cncy.20027
- Sawhney, M. S., Devarajan, S., et al. Comparison of carcinoembryonic antigen and molecular analysis in pancreatic cyst fluid. Gastrointest Endosc. 2009; 69(6):1106-10. doi: 10.1016/j.gie.2008.08.015.
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
- 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.
- V. Chernyak et al, Incidental pancreatic cystic lesions Radiology 2015 274 161-9
- 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
- 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.
- 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.
- 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
- Kushnir VM, Mullady DK, Das K, et al. J Clin Gastroenterol. 2019;53(9):686-692. DOI: 10.1097/MCG.0000000000001118.
- Gonda TA, Viterbo D, Gausman V, et al. Clin Gastroenterol Hepatol. 2017;15:913-919.
- Data on File.