Physicians: FAQ's

 

Q. What is PathFinderTG®?

PathFinderTG is a molecular DNA-based cancer diagnostic test that obtains a genetic fingerprint of mutations from routine histology and cytology slides as well as cytology fluid samples. This test is only offered by RedPath Integrated Pathology, Inc.

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Q. Who is RedPath Integrated Pathology?

RedPath is a CLIA-certified and CAP-accredited commercial laboratory and one of the first to integrate molecular DNA analysis with routine pathology review. Our PathFinderTG analysis provides early and objective diagnostic information for pathologists and clinicians when standard testing is inconclusive.

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Q. What is the benefit of using the PathFinderTG test?

When a case is difficult to diagnose using traditional pathology methods, PathFinderTG can provide valuable clinical information leading to a more comprehensive diagnosis and characterization of dysplasia and cancer. The objective information provided by this molecular-based analysis can assist pathologists, oncologists and surgeons in optimizing the clinical management of their patients, leading to better treatment decisions and improved patient outcomes.

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Q. What is the basis of PathFinderTG?

PathFinderTG is based on over 17 years of research and clinical studies. Clinical results have been reported in more than 100 peer-reviewed articles. PathFinderTG is clinically validated in our CLIA-certified and CAP-accredited high-complexity commercial clinical laboratory for diagnosing and characterizing cancer specimens.

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Q. What are the indications for use?

PathFinderTG is a molecular analysis of mutations in DNA for cases where traditional pathology results in an "indeterminate," "suspicious," or "atypical" diagnosis. This objective information can help resolve diagnostic dilemmas and lead to a more personalized treatment plan.

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Q. How is the test performed?

We use a proprietary process that begins with the microdissection of cells from targeted areas of interest on chemically fixed histology and cytology slides. RedPath is also able to test acellular fluids. The process incorporates DNA amplification, as well as molecular profiling against a broad panel of mutations (15 to 20 different markers) that include tumor suppressor genes and oncogenes known to be part of the mutational profile for each tumor type. Combined with the histological review, PathFinderTG provides a comprehensive analysis.

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Q. How much tissue or material is required for solid tumors or fluid analysis?

  • For formalin fixed, paraffin embedded tissues, we require one stained H&E along with 4 to 6 re-cut slides (4-5 micron sections), de-paraffinized for each area of interest.
  • For cytology samples, including FNAs, one or two stained cytology slides are appropriate.
  • Archived slides or blocks may also be analyzed.
  • For effusions, ascites or cyst aspirates, 500µl of fluid is requested.

Contact Client Services for information regarding smaller samples or fluid volumes.

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Q. How are the results reported?

The PathFinderTG report is a comprehensive description that incorporates the morphologic review with the molecular analysis in a form that is easily understood. A summary of the number and type of mutations found and a diagnosis with detailed commentary is provided in the context of available clinical history and pathology information. The report is delivered via fax or electronically through RedPath’s secure Physician's Web Portal.

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Q. What is the turn-around time?

A final report is typically provided within seven business days from the date of receipt of a properly submitted specimen with completed and signed test requisition.

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Q. Is the PathFinderTG test currently covered by health insurance?

RedPath bills Medicare and Third Party insurance companies directly. Insurance may cover all or part of the bill. Where required by law, RedPath bills hospitals and patients for co-insurance or deductible amounts. Our reimbursement staff will work diligently to obtain payment from your patient’s insurance company and will do everything possible to reduce any payment burden to the patient. In the event of non- payment by third party payers, physicians and institutions will not be billed.

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Q. How do I order PathFinderTG?

Simply call our toll-free number at 1-800-495-9885 and ask for Client Services. We will provide you with a test requisition form and our RedPak© shipping kit. You may also print the PathFinderTG requisition form and shipping instructions from our website. Complete the requisition and ship the histology, cytology slides and/or fluids to:

RedPath Integrated Pathology, Inc.
2515 Liberty Avenue
Pittsburgh, PA 15222

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