Lay Summary: Pathfinder TG is a promising technology but credible medical evidence is lacking and this should be considered experimental.
Pathfinder TG is a promising technology but credible medical evidence is lacking and it should be considered experimental.
RedPath Integrated Pathology, Inc., is a CLIA, CAP accredited reference laboratory located in Pittsburgh, Pennsylvania. RedPath provides advanced molecular topographic genotyping utilizing its PathFinder TG® process when microscopic analysis and special staining methods cannot provide the needed definitive diagnosis on specimens sent to RedPath by Pathologists and Facilities from across the U.S. As there does not exist a specific CPT/HCPCS code or codes to define the PathFinder TG® service, claims for this service have been billed using a variety of coding combinations and not otherwise classified (NOC) codes. It is not FDA approved and I was not able to find guidelines or consensus statements.
As best as I can determine, this laboratory provides high-end molecular and pathologic analyses bringing advanced technologies together to diagnose difficult to assess cases and pathological dilemmas. The references I cite provide a description of the general Pathfinder approach.
There is still insufficient evidence to support the test. I quote from HealthNet update of 2010: “There continues to be insufficient evidence in the published, peer-reviewed, scientific literature to demonstrate that topographic genotyping or the Pathfinder TG can be used as methods to assist in the diagnosis or management of individuals with cancer when microscopic analysis and staining fail to provide a definitive diagnosis. This testing has not been adequately compared with established testing methods and impact on health outcomes is not known at this time. The clinical utility of topographic genotyping and the Pathfinder TG in the diagnosis and management of cancer has not yet been established through well-designed clinical trials.”
Molecular Tumor Profiling in the Diagnosis of Patients with Carcinoma of Unknown Primary Site: Retrospective Evaluation of Gene Microarray Assay, J Hainsworth, R Pillai, DW Henner, M Halks-Miller, C Lane, FA Greco. J Molec Bio and Diagn, June 27, 2011
- Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015 Feb; 47(2): 136-42.
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- Wu BU, Sampath K, Berberian CE, Kwok KK, Lim BS, Kao KT. Prediction of malignancy in cystic neoplasms of the pancreas: a population-based cohort study. Am J Gastroenterol. 2014 Jan; 109(1): 121-9.
- Gaujoux S, Brennan MF, Gonen M, D’Angelica MI, DeMatteo R, Fong Y. 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 Apr; 212(4): 590-600.
- Al-Haddad M, DeWitt J, Sherman S, Schmidt CM, LeBlanc JK, McHenry L, Coté G, El Chafic AH, Luz L, Stuart JS, Johnson CS, Klochan C, Imperiale TF. Performance characteristics of molecular (DNA) analysis for the diagnosis of mucinous pancreatic cysts. Gastrointest Endosc. 2014 Jan; 79(1): 79-87.
- Kaimakliotis P, Riff B, Pourmand K, Chandrasekhara V, Furth EE, Siegelman ES, Drebin J. Sendai and Fukuoka Consensus Guidelines Identify Advanced Neoplasia in Patients with Suspected Mucinous Cystic Neoplasms of the Pancreas. Clin Gastroenterol Hepatol. 2015 Oct; 13(10): 1808-15.
Validation and Reproducibility of a Microarray-Based Gene Expression Test for Tumor Identification in Formalin-Fixed, Paraffin-Embedded Specimens, R Pillai, R Deeter, CT Rigl, JS Nystrom, M Halks-Miller, L Buturovic, WD Henner. J Molec Diag 13 (2011) pp. 48-56
Gene expression profiles help identify the Tissue of Origin for metastatic brain cancers, A Wu, J Drees, H Wang, S VandenBerg, A Lal, WD Henner, R Pillai. Diag Pathol, 2010, 5:26
Trikalinos TA, Terasawa T, Raman G. A systematic review of loss-of-heterozygosity based topographic genotyping with PathfinderTG. Technology Assessment Report. Project ID: GEND0308. Prepared by the Tufts Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) under Contract No. HHSA 290 2007 10055 I. Rockville, MD: AHRQ; March 1, 2010.
National Institute for Health and Clinical Excellence (NICE). Diagnosis and management of metastatic malignant disease of unknown primary origin. Clinical Guideline. Draft for Consultation. London, UK: NICE; December 2009.