ALK by FISH Test: Booking, Price, and Results
About ALK by FISH Test
| Field | Value |
|---|---|
| Also Known As | ALK FISH, ALK Gene Rearrangement by FISH, ALK Break-Apart FISH, EML4-ALK FISH, ALK (2p23) Rearrangement FISH Gene Fusion Test, or ALK/EML4 (NSCLC) |
| Sample Type | Tumour tissue (formalin-fixed, paraffin-embedded/FFPE block from biopsy or surgical resection) |
| Fasting Required | No |
| Report Time | 9 Days |
| Recommended For | Adults of any gender diagnosed with or suspected of having non-small cell lung cancer (NSCLC), anaplastic large cell lymphoma or inflammatory myofibroblastic tumours |
| Price | Starting at ₹11,000 |
What Is an ALK by FISH Test?
The ALK by FISH test detects specific gene rearrangements in the anaplastic lymphoma kinase (ALK) gene using a technique called fluorescence in situ hybridisation (FISH). It is most commonly ordered for patients diagnosed with non-small cell lung cancer (NSCLC) to determine whether their tumour carries a particular genetic change. The sample used is tumour tissue obtained through a biopsy or surgical procedure, not a routine blood draw. This test is also known as ALK FISH or ALK Gene Rearrangement by FISH.
What Does an ALK by FISH Test Measure?
The ALK by FISH test procedure examines tumour tissue at a molecular level. It looks for structural changes in the ALK gene and how the gene's components are arranged. Here is what the test analyses:
| Component | What It Looks For |
|---|---|
| ALK Gene Rearrangement | Structural changes (breaks or splits) in the ALK gene on chromosome 2p23 that cause abnormal tumour growth |
| Signal Patterns | Fluorescent probes labelled in orange and green reveal whether gene segments have separated (rearranged) or stayed fused (normal) |
| EML4-ALK Fusion | The most common rearrangement, where the EML4 gene fuses with ALK due to a chromosomal inversion, producing an abnormal protein that drives tumour growth |
Why Is an ALK by FISH Test Done?
Doctors order this test to understand the genetic makeup of a tumour and to guide treatment decisions. The result directly influences whether a patient may benefit from specific targeted therapies.
Common Symptoms That May Require This Test
A doctor may request this test when a patient presents with the following symptoms, particularly when lung cancer is suspected:
- Persistent cough that does not resolve over weeks
- Shortness of breath without an obvious cause
- Chest pain, especially during breathing or coughing
- Unexplained weight loss over a short period
- Coughing up blood
- Ongoing fatigue not explained by other conditions
- Hoarseness or a change in voice quality
Conditions This Test Can Help Detect
The ALK by FISH analysis is used to identify gene rearrangements in several cancers. These include:
- Non-small cell lung cancer (NSCLC): ALK rearrangement is found in approximately 3% to 7% of all NSCLC patients, and in up to 20% to 30% of younger, non-smoking patients with lung adenocarcinoma.
- Anaplastic large cell lymphoma (ALCL): A rare T-cell lymphoma where ALK gene changes are present in 84% to 91% of cases in children.
- Inflammatory myofibroblastic tumour (IMT): A rare soft tissue tumour; approximately 50% to 70% of IMT cases carry ALK gene rearrangements.
How to Prepare and What to Expect
No special preparation is required from the patient for this test. The sample is tumour tissue, not blood or urine, so the patient's diet and daily routine are not directly relevant to sample collection.
Do You Need to Fast?
No fasting is required for the ALK by FISH test. There are no dietary restrictions before or after the procedure.
Practical Tips Before Your Test
- Bring a detailed clinical history including your symptoms, previous test results and family history, as this is required for the test
- Provide the pathology report that documents the tumour type and histology, if available
- No medication adjustments are required, but inform your doctor of all medicines you are currently taking
- The tissue sample is typically collected during a bronchoscopy, CT-guided biopsy, or surgical procedure arranged by your treating doctor
Step-by-Step Procedure
- A doctor collects tumour tissue through a biopsy (such as a bronchoscopy or CT-guided needle biopsy) or surgical resection.
- The tissue is fixed in formalin and embedded in paraffin wax to create an FFPE block, which preserves the tissue for analysis.
- Thin slices (4 to 6 micrometres thick) are prepared on glass slides in the laboratory.
- Slides are treated with enzymes to expose the target DNA, which is then heat-denatured and exposed to fluorescent ALK break-apart probes.
- A specialised fluorescence microscope is used to examine at least 50 to 100 tumour cells and assess the signal patterns from the probes.
- The percentage of cells showing a rearranged ALK signal is calculated, and the result is reported.
Factors That Can Affect Accuracy
Several factors may influence the reliability of the test result:
- Poor quality or inadequately fixed tissue can interfere with probe binding
- Low tumour cell content in the sample (less than 5 to 10% tumour cells) may reduce accuracy
- Improper formalin fixation at the time of biopsy
- Laboratory expertise in interpreting FISH signal patterns
- A small proportion of cases (approximately 6%) may fall into a borderline group where results are statistically uncertain
Understanding Your ALK by FISH Test Results
Results must always be reviewed by a qualified oncologist or pathologist in the context of the patient's full clinical picture. The table below provides general interpretation guidelines.
| Result | Threshold | What It Suggests |
|---|---|---|
| Positive | 15% or more of tumour cells showing ALK rearrangement | ALK gene rearrangement detected; tumour may respond to ALK inhibitor therapy |
| Negative | Fewer than 10% of cells showing rearrangement | No ALK rearrangement detected; ALK inhibitors are unlikely to be effective |
| Equivocal | 10% to 50% of cells showing positive signal patterns | Borderline result; additional testing such as NGS or IHC may be needed |
These ranges are general guidelines. Your doctor will interpret your results based on your age, health history and other factors. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
- In borderline cases (approximately 6% of NSCLC patients), the statistical sampling effect limits the reliability of the FISH result, and supplementary testing is often advisable.
- Tumour samples with very few cancer cells may not provide enough material for a conclusive reading, regardless of the technique used.
How to Maintain Healthy Levels
This test does not measure a level that can be improved through lifestyle changes, as it detects a genetic alteration in tumour cells. However, the following general tips support overall health during cancer care:
- Attend all scheduled follow-up appointments with your oncologist after receiving results.
- Maintain a balanced diet and stay well-hydrated throughout treatment.
- Avoid smoking, as it is a known risk factor for lung cancer and may affect treatment outcomes.
- Discuss any new or changing symptoms with your doctor promptly, particularly if you are already on a treatment plan.
Lupin Diagnostics ALK by FISH Test Price
The ALK by FISH test cost at Lupin Diagnostics starts at ₹11,000. This test requires a visit to a Lupin Diagnostics centre or submission of the FFPE tissue block; home collection is not available for this test.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 11000 |
| CHENNAI | 11000 |
| HYDERABAD | 11000 |
| KOLKATA | 11000 |
| NAVI MUMBAI | 11000 |
| PUNE | 11000 |
Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps to book the ALK by FISH test online through Lupin Diagnostics:
- Select the test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time for sample submission (FFPE tissue block or biopsy material as advised by your doctor).
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
The ALK by FISH test identifies whether a tumour carries a rearrangement in the ALK gene. This information helps oncologists decide whether a patient with non-small cell lung cancer or another ALK-driven cancer may benefit from specific targeted therapies.
This test is recommended for patients diagnosed with non-small cell lung cancer (NSCLC), particularly those with adenocarcinoma. It is especially relevant for younger patients who are light smokers or non-smokers. It may also be ordered for patients with anaplastic large cell lymphoma or inflammatory myofibroblastic tumours.
The test requires tumour tissue, not blood. Tissue is obtained through a biopsy procedure (such as a bronchoscopy or CT-guided biopsy) or during surgical removal of the tumour. The tissue is then processed into an FFPE block before being sent to the laboratory.
The report delivery time at Lupin Diagnostics is 9 days. This is because the ALK by FISH test procedure involves multiple laboratory steps, including tissue processing, probe hybridisation and microscopic analysis by a specialist.
A positive result indicates that the ALK gene is rearranged in the tumour cells. This suggests the cancer may respond well to ALK inhibitor therapies. Your oncologist will review the result alongside other clinical findings to recommend next steps.
No. A negative ALK FISH result only means that no ALK gene rearrangement was found in the tested tissue. It does not rule out cancer, and it does not exclude the possibility of sensitivity to targeted therapy through other pathways. Other genetic tests, such as EGFR or KRAS mutation testing, may be recommended alongside this result.
No. While it is most commonly ordered for NSCLC, the test is also relevant for anaplastic large cell lymphoma and inflammatory myofibroblastic tumours. Your doctor will advise whether this test is appropriate based on your specific diagnosis and tissue type.
ALK by FISH Test: Booking, Price, and Results
