NTRK FusionSEQ : 1016976

Test Code
MDFCPNTRKFSEQ or 1016976

Alias/See Also
NTRK

CPT Codes
81194

Includes
The NTRK FusionSEQ will detect the presence of gene rearrangements (fusions) in NTRK1, NTRK2 and NTRK3.
 
med fusion can deliver your SEQ report by fax or eLabs Results Portal. Please contact your med fusion representative to make them aware of your desired delivery and if you need access to the results portal. The results portal will provide links for additional therapy and clinical trial information associated with the patient’s molecular profile. If you have any further questions, additional needs, or would like to speak with med fusion’s scientific staff, pathologists, or client services, please contact us at 972-966-7050/844-966-7050.

Instructions
Tissue.

Transport Container
Submit paraffin embedded tissue block accompanied by a circled H&E slide indicating the area to be examined: submit in sterile biohazard plastic bag at ambient temperature or on ice pack in summer.
 
Slides: submit 6-10 slides (10-micron sections) for resection or surgical specimens and 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder at ambient temperature.
  
Specimen to be tested should contain a minimum of 10 percent tumor nuclei. Decalcified specimens are not acceptable.

Transport Temperature
Paraffin embedded Tissue: Ambient or on ice pack in summer; Slides: Ambient.

Specimen Stability
Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen.

Methodology
Anchored Multiplex PCR (AMP™), Next Generation Sequencing

Setup Schedule
Monday & Wednesday

Report Available
10-14 days

Limitations
Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Reference Range
An interpretive report will be provided.

Clinical Significance
The  NTRK FusionSEQ assay will detect the presence of gene rearrangements (fusions) in NTRK1, NTRK2 and NTRK3. FDA-approved therapies and clinical trials are available for patients with these genomic abnormalities in certain solid tumors, and the detection of these abnormalities is beneficial in the management of disease and survival of the patient.

Performing Laboratory
med fusion



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.