ALK (D5F3) IHC reflex to FISH for NSCLC

The ALK (D5F3) immunohistochemistry (IHC) test is a laboratory procedure that uses an antibody called D5F3 to detect the presence of anaplastic lymphoma kinase (ALK) protein in tissue samples. FISH (Fluorescence in situ hybridization) test will be performed if IHC is positive.

• To diagnose non-small cell lung cancer (NSCLC): ALK rearrangements are found in about 5% of NSCLC cases. The ALK (D5F3) IHC test can help to diagnose NSCLC and determine if it is ALK-positive or ALK-negative.
• To guide treatment decisions: ALK-positive NSCLC is often more sensitive to certain types of targeted therapy than ALK-negative NSCLC. The ALK (D5F3) IHC test can help to determine if a patient is eligible for targeted therapy.
• To monitor treatment response: The ALK (D5F3) IHC test can be used to monitor the response to targeted therapy. If the test results become negative after treatment, it may mean that the treatment is working.
• To diagnose other types of cancer: The ALK (D5F3) IHC test can also be used to diagnose other types of cancer, such as lymphoma and inflammatory myofibroblastic tumor.
• To identify individuals at risk of developing cancer: In some cases, the ALK (D5F3) IHC test may be used to identify individuals who are at high risk of developing cancer, such as those with a family history of ALK-positive cancer.

The ALK (D5F3) IHC test may be recommended for people who have symptoms of NSCLC or other types of cancer that are known to be associated with ALK rearrangements. The test may also be recommended for people who are at high risk of developing one of these types of cancer.

Abnormal results may indicate the presence of ALK gene rearrangements, which can help guide treatment decisions for NSCLC patients. However, abnormal results do not confirm a diagnosis and should be discussed with your doctor for proper interpretation and further evaluation.

A small sample of tissue is removed from the patient and sent to a laboratory for testing. The tissue sample is then stained with the D5F3 antibody. If ALK protein is present in the tissue sample, it will bind to the antibody and turn a brown color. The stained tissue sample is then examined under a microscope to see if there are any ALK-positive cells present. If IHC is positive, FISH test is performed. 

• Ensure that you provide paraffin blocks of your tumour sample along with relevant clinical and radiological details.
• No additional preparations, such as fasting or dietary restrictions, are usually required.
• Please reach out to your healthcare provider for any specific instructions or requirements.

• EGFR mutation analysis: Determines mutations in the epidermal growth factor receptor gene
• PD-L1 testing: Assesses PD-L1 protein expression in NSCLC tumour cells
• Next-generation sequencing (NGS): Identifies multiple genetic alterations associated with NSCLC

• ALK IHC testing
• ALK FISH testing 

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It refers to a group of lung cancers that are not small cell carcinomas.

ALK (D5F3) Reflex FISH is a diagnostic test that combines immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to detect ALK gene rearrangements in solid tumours, particularly in non-small cell lung cancer (NSCLC). It guides targeted therapy decisions for personalised treatment plans.

Yes, home sample collection is available for the ALK (D5F3) Reflex FISH test. This service allows patients to have samples collected at home by trained phlebotomists who ensure accuracy and safety, providing timely and reliable results.

There are no "normal" levels for ALK (D5F3) Reflex FISH. The results are categorised as positive, negative, or equivocal based on the presence and extent of ALK protein expression and gene rearrangement detected by the test.

The ALK (D5F3) Reflex FISH test is used to identify ALK gene rearrangements in patients with NSCLC. The results guide the use of targeted therapies such as ALK tyrosine kinase inhibitors (TKIs) for personalised treatment.

Testing is typically done once at the initial diagnosis of NSCLC or when there is a suspicion of ALK rearrangement based on clinical or pathological findings. Repeat testing may be considered if the disease progresses or the treatment response changes.

The timing of the ALK (D5F3) Reflex FISH test is determined by the need for diagnostic information to guide treatment decisions. It is usually performed at the time of initial diagnosis or when considering a change in treatment strategy.

No, fasting is not required for the ALK (D5F3) Reflex FISH test. It involves analysing tumour tissue samples rather than blood or other bodily fluids, so dietary restrictions are not necessary.

Ensure that the tissue sample is properly fixed and processed according to the laboratory's guidelines. Include the necessary pathology reports and follow the transportation instructions provided by the laboratory to maintain sample integrity and avoid delays in testing.

The ALK (D5F3) Reflex FISH test measures ALK protein expression by IHC and ALK gene rearrangement by FISH. IHC results are categorised as positive, negative, or equivocal, while FISH results are positive if ≥50% of cells show non-fused ALK genes.

ALK (D5F3) Reflex FISH should be done at the time of initial diagnosis of NSCLC, especially for adenocarcinoma cases, regardless of stage. It may also be performed when considering targeted therapy or if there is a suspicion of ALK rearrangement.

The turnaround time for ALK (D5F3) Reflex FISH results can vary depending on the laboratory and the complexity of the case. Typically, it takes 5-10 working days from the time the sample is received by the laboratory.

The reports for ALK (D5F3) Reflex FISH are usually available within a week depending on the day/time the sample was collected and processed by the lab.