DESCRIPTION
Molecular anatomic pathology testing (i.e., PathFinderTG®) is being investigated to be used adjunctively in cases in which a definitive pathologic diagnosis cannot be rendered on a tissue or cytology specimen, either due to inadequate specimen or equivocal histologic or cytologic findings. RedPath, the test provider, suggests that the PathFinderTG® results provide useful and definitive diagnostic and prognostic information and reliably predict treatment response for multiple organ systems.
The testing involves the following steps:
Manual microdissection to identify and procure abnormal cells from existing pathology specimens
DNA extraction and amplification (e.g., PCR)
DNA sequencing to identify oncogenic mutations
Integrating this molecular information with the cytologic or histologic findings provided by the pathologist of record to provide a definitive diagnosis
For some specimens such as fluid aspirates, DNA is extracted from the fluid, since there may be little or no cellular content. The molecular anatomic pathology testing consists of applying panels of molecular markers previously defined for each organ system or clinical question.
POLICY
Molecular anatomic pathology testing for all indications, including, but not limited to the evaluation of pancreatic cyst fluid and of suspected or known gliomas, is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed studies with long-term follow-up published in peer-reviewed journals regarding the use of molecular anatomic pathology testing (i.e., PathFinderTG®) are not available. It is not known if this technology improves net health outcomes. Also, outcomes with this technology compared with existing alternatives (i.e. incremental value) are not known.
Potential uses described by the company (RedPath) include determining reactive versus neoplastic lesions, benign versus malignant lesions, biologically indolent versus aggressive tumors, which premalignant lesions will or will not progress into cancer, whether a synchronous or metachronous tumor represents metastatic spread or a new primary, and expected responses to treatment for various tumors. RedPath proposes that PathFinderTG® is appropriate in clinical practice when the results will alter clinical decision-making. The aim of PathFinderTG® testing is to integrate molecular findings into the pathology diagnosis.
This patented diagnostic test is 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.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2009). PathFinderTG® molecular testing (2.04.52). Retrieved March 3, 2010 from BlueWeb. (20 articles and/or guidelines reviewed)
Khalid, A., Zahid, M., Finkelstein, S. D., LeBlanc, J. K., Kaushik, N., Ahed, N., et al. (2009). Pancreatic cyst fluid DNA analysis in evaluating pancreatic cysts: A report of the PANDA study. Gastrointestional Endoscopy, 69 (6), 1095-1002.
Lassman, A. B. and Holland, E. C. (2007). Incorporating molecular tools into clinical trials and treatment for gliomas? Current Opinion in Neurology, 20 (6), 708-711.
ORIGINAL EFFECTIVE DATE: 8/14/2010
MOST RECENT REVIEW DATE: 8/14/2010
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