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DESCRIPTIONThe patented PathFinderTG® test is a molecular test to be used adjunctively when a definitive pathologic diagnosis cannot be made because of inadequate specimen or equivocal histologic or cytologic findings. RedPath Integrated Pathology (Pittsburgh, PA), the test provider, states that the PathFinderTG® produces mutational profiles to help physicians resolve complex diagnostic dilemmas in patients who are at risk of cancer.
Topographic genotyping (TG), also called molecular anatomic pathology, integrates microscopic analysis (anatomic pathology) with molecular tissue analysis. Under microscopic examination of tissue and other specimens, areas of interest may be identified and microdissected to increase tumor cell yield for subsequent molecular analysis. TG may permit pathologic diagnosis when first-line analyses are inconclusive.
RedPath Integrated Pathology has patented a proprietary platform, called PathFinderTG®, to provide mutational analyses of patient specimens. The patented technology permits analysis of tissue specimens of any size, “including minute needle biopsy specimens,” and any age, “including those stored in paraffin for over 30 years.” RedPath currently offers 5 PathFinderTG® tests (listed and briefly described in Table 1). As stated on the company website, PathFinderTG® integrates molecular analyses with first-line results (when these are inconclusive) and pathologist interpretation to provide “clinically valid and useful diagnostic and prognostic information.” Although the website states that “PathFinderTG® is clinically validated as reported in over 200 peer-reviewed articles,” test performance information is not provided.
Table 1. PathFinderTG® Tests
Test Description Specimen Type(s)
ERCP: endoscopic retrograde cholangiopancreatography.
These patented diagnostic tests are available only through RedPath Integrated Pathology (Pittsburgh, PA). The PathFinderTG® Molecular Testing is not subject to review by the U.S. Food and Drug Administration (FDA) because it is a laboratory-developed test (LDT) conducted only at RedPath Integrated Pathology’s licensed laboratory. Laboratories performing LDTs must be licensed for high-complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). RedPath is licensed under CLIA.
POLICYMolecular testing using the PathFinderTG® system is considered investigational for all indications including the evaluation of pancreatic cyst fluid, suspected or known gliomas, and Barrett esophagus.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY4/29/2008: Policy added
7/17/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
4/27/2009: Policy reviewed, no changes
07/09/2010: Policy description revised to define PCR as "polymerase chain reaction." Policy statement unchanged.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
08/14/2013: Policy reviewed; no changes.
07/31/2014: Policy reviewed; description revised. Policy statement revised to remove "and of" and add "and Barrett esophagus." It previously stated: Molecular testing using the PathFinderTG® system is considered investigational for all indications including the evaluation of pancreatic cyst fluid and of suspected or known gliomas.
08/03/2015: Code Reference section updated for ICD-10.
09/22/2015: Policy reviewed; policy statement unchanged. Investigative definition updated in Policy Guidelines section.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 2.04.52
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.