FISH - NTRK 1 Gene Rearrangement Assay Test
Short Name: FISH NTRK1
Also known as: NTRK1 FISH Test, NTRK1 Gene Fusion Assay, NTRK1 Rearrangement FISH Panel, Neurotrophic Tyrosine Receptor Kinase 1 Rearrangement Test
FISH - NTRK 1 Gene Rearrangement Assay Test test available at DNA Labs India for ₹7,020. Uses FISH (Fluorescence In Situ Hybridization), In Situ Hybridization with NTRK1 (1q21.3) specific probes on Formalin-fixed paraffin-embedded (FFPE) tissue block or three 4-micron tissue sections on Poly-L-Lysine coated slides samples. Results in Sample accepted daily by 6 PM. Report available within 4 working days from sample receipt.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr Pasupathy Arumugam
Consultant Pathologist · Reg: 21521
Last reviewed: September 7, 2026
Overview
The primary purpose of the FISH - NTRK 1 Gene Rearrangement Assay Test is to detect the presence or absence of NTRK1 gene rearrangements in tumour tissue samples. This information serves several critical clinical purposes: it helps confirm a molecular diagnosis of NTRK1 fusion-positive cancer, guides the selection of targeted NTRK inhibitor therapies such as Larotrectinib or Entrectinib, provides prognostic information particularly in papillary thyroid carcinoma, and helps oncologists make informed treatment decisions. The test is an essential component of precision oncology, ensuring that patients with NTRK1-driven cancers receive the most appropriate and effective therapy available.
- Test Code
- 592
- CPT Code
- 88377
- ICD Code
- Z12.4
- Price
- ₹7,020
- Sample Type
- Formalin-fixed paraffin-embedded (FFPE) tissue block or three 4-micron tissue sections on Poly-L-Lysine coated slides
- Result Time
- Sample accepted daily by 6 PM. Report available within 4 working days from sample receipt.
- Fasting Required
- No
- Method
- FISH (Fluorescence In Situ Hybridization), In Situ Hybridization with NTRK1 (1q21.3) specific probes
Sample Collection
Ensure a tissue biopsy or surgical resection specimen has been collected by the treating physician. The specimen must be formalin-fixed and paraffin-embedded (FFPE). Duly fill the Genomics Clinical Information Requisition Form (Form 20) with complete clinical history, tumour type, and relevant pathological details. Submit the FFPE block or three 4-micron tissue sections on Poly-L-Lysine coated slides.
Method: Tissue biopsy or surgical resection specimen (collected by treating physician/oncologist)
Laboratory Analysis
Tissue collection is performed by the treating physician or surgeon via biopsy or surgical resection. The specimen is then processed into a formalin-fixed paraffin-embedded block by the pathology laboratory. No additional patient-side collection procedure is required for this test.
Report Delivery
The FFPE tissue block or slides are shipped to DNA Labs India at room temperature. Ensure proper labelling and packaging to prevent damage during transit. Results are typically available within 4 working days from sample receipt at the laboratory.
Timeline: Sample accepted daily by 6 PM. Report available within 4 working days from sample receipt.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of the FISH - NTRK 1 Gene Rearrangement Assay Test is to detect the presence or absence of NTRK1 gene rearrangements in tumour tissue samples. This information serves several critical clinical purposes: it helps confirm a molecular diagnosis of NTRK1 fusion-positive cancer, guides the selection of targeted NTRK inhibitor therapies such as Larotrectinib or Entrectinib, provides prognostic information particularly in papillary thyroid carcinoma, and helps oncologists make informed treatment decisions. The test is an essential component of precision oncology, ensuring that patients with NTRK1-driven cancers receive the most appropriate and effective therapy available.
How to Prepare
- Submit a formalin-fixed paraffin-embedded (FFPE) tissue block, or three 4-micron tissue sections mounted on Poly-L-Lysine coated slides
- Ship specimens at room temperature in appropriate protective packaging
- Duly fill the Genomics Clinical Information Requisition Form (Form 20) — this is mandatory for test processing
- Include complete clinical information including tumour type, stage, and prior treatment history on the requisition form
- Label all specimens clearly with patient name, unique identification number, and date of collection
- Free home pickup of specimens is available for online bookings across India
Doctor's Notes
Reviewed by Dr Pasupathy Arumugam — MBBS, MD (Pathology) · Reg. No. 21521
"NTRK1 gene rearrangements, though rare, represent an actionable target in modern oncology. Detection via FISH is critical for identifying patients who may benefit from FDA-approved NTRK inhibitors such as Larotrectinib and Entrectinib. Early and accurate identification of NTRK1 fusions can significantly influence treatment decisions and improve patient outcomes, particularly in papillary thyroid carcinoma and other NTRK fusion-positive solid tumors."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Unlabelled or mislabelled specimens
- Missing or incomplete Genomics Clinical Information Requisition Form (Form 20)
- Specimens with extensive necrosis (>50% necrotic tissue)
- Tissue sections that are significantly folded, torn, or damaged
- Specimens fixed in fixatives other than 10% neutral buffered formalin
- Insufficient tumour content for reliable FISH analysis
Understanding Your Results
Negative (No Rearrangement)
No NTRK1 gene rearrangement was detected. The normal FISH signal pattern (intact signals) was observed in the majority of tumour cells analysed. This result does not completely exclude the presence of NTRK rearrangements in other family members (NTRK2, NTRK3) or rearrangements below the detection threshold of FISH.
Positive (Rearrangement Detected)
NTRK1 gene rearrangement was detected. A break-apart FISH signal pattern was observed in the tumour cells, indicating fusion of the NTRK1 gene with an alternative partner gene. This result is clinically significant and may indicate eligibility for NTRK inhibitor therapy such as Larotrectinib or Entrectinib. Clinical correlation and further molecular characterisation are recommended.
Equivocal / Non-contributory
The FISH result is indeterminate due to technical factors such as weak signal intensity, high background fluorescence, or insufficient tumour cell content. Repeat testing on a new specimen or alternative molecular methods (e.g., NGS) may be recommended.
Consult your oncologist or treating physician if your test result is positive for NTRK1 gene rearrangement, as targeted NTRK inhibitor therapies may be available. If your result is negative but clinical suspicion remains high, discuss additional testing options such as NTRK2/NTRK3 FISH or comprehensive next-generation sequencing (NGS) panels. Always discuss your results with a qualified healthcare professional before making any treatment decisions.
Limitations
- ⚠This test detects only NTRK1 gene rearrangements and does not identify rearrangements in NTRK2 or NTRK3 genes
- ⚠FISH may not identify the specific fusion partner gene; additional molecular testing (e.g., NGS or RT-PCR) may be required for complete fusion characterisation
- ⚠False-negative results may occur if the rearrangement involves complex structural variants not detectable by standard break-apart FISH probes
- ⚠The test requires a minimum viable tumour cell content in the submitted specimen
- ⚠Results should be interpreted in conjunction with clinical findings, histopathology, and other molecular tests
Risks & Considerations
- ●No direct risk to the patient from the FISH test itself, as it is performed on an already-collected tissue specimen
- ●Risks associated with the original tissue biopsy or surgical procedure are separate and should be discussed with the treating physician
- ●False-negative results may lead to omission of targeted therapy; clinical correlation is essential
Interfering Factors
- ●Inadequate tissue fixation or over-fixation in formalin may affect probe hybridisation and signal quality
- ●Tumour necrosis or insufficient tumour cell content in the biopsy specimen may yield false-negative results
- ●Excessive background fluorescence due to suboptimal tissue processing
- ●Previous decalcification of bone tissue specimens may degrade DNA and impair FISH signal detection
- ●Use of non-approved fixatives may interfere with probe binding
Compare With Similar Tests
| Test | FISH - NTRK 1 Gene Rearrangement Assay Test | NGS-Based NTRK Fusion Panel | RT-PCR for NTRK Fusions | Immunohistochemistry (IHC) for pan-TRK |
|---|---|---|---|---|
| Comparison | FISH - NTRK 1 Gene Rearrangement Assay Test | NGS can identify all three NTRK gene fusions and their specific fusion partners simultaneously, whereas FISH targets only NTRK1. NGS requires different specimen requirements and has a longer turnaround time but provides more comprehensive molecular information. | RT-PCR is highly sensitive for known fusion variants but may miss novel or atypical fusions. FISH is better suited for detecting rearrangements regardless of the fusion partner, making it a preferred screening method. | Pan-TRK IHC is a cost-effective screening tool but has variable sensitivity and specificity depending on the tumour type and fusion partner. FISH provides a more definitive assessment of gene rearrangement at the chromosomal level. |
Frequently Asked Questions
What is the FISH - NTRK 1 Gene Rearrangement Assay Test?
What is the cost of the FISH - NTRK 1 Gene Rearrangement Assay Test at DNA Labs India?
What sample is required for this test?
Is fasting required before the FISH NTRK1 test?
How long does it take to get the results?
What does a positive NTRK1 rearrangement result mean?
What does a negative NTRK1 rearrangement result mean?
Is the FISH NTRK1 test covered by insurance in India?
How is FISH different from NGS for detecting NTRK fusions?
Which cancers are associated with NTRK1 gene rearrangements?
What are NTRK inhibitor therapies, and how do they work?
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