FISH‑HER2 (ERBB2) Reflex Test in UAE | 1,500 AED | DHA Licensed

Executive Summary & Core Metrics

DNA Labs UAE delivers the gold‑standard FISH‑HER2 reflex test with definitive amplification status reporting. Our ISO 9001:2015 accredited digital fluorescence scoring system ensures 99.9% diagnostic sensitivity and precise clinical accuracy. Service includes dedicated telephonic post‑test clinical guidance, direct billing verification via WhatsApp, and secure medical courier retrieval of archived tissue specimens.

Accuracy Guarantee: 99.9% diagnostic sensitivity via ISO 9001:2015 accredited digital fluorescence scoring.
Secure Logistics: Hospital extraction only with Secure Medical Courier Solid Tissue Specimen Retrieval.
Clinical Guidance: Telephonic post‑test clinical guidance from our specialist physician.
Insurance: Direct billing verification via WhatsApp +971 54 548 8731.

Test Overview & Methodology

HER2 (ERBB2) FISH is the gold‑standard molecular test to resolve ambiguous IHC results in invasive breast cancer, guiding targeted anti‑HER2 therapy selection. It precisely counts HER2 gene copies and chromosome 17 centromere signals, delivering a definitive amplification status within 7 working days.

Feature	Our FISH‑HER2 Test	Closest Alternative
Precision / Method	ISO 9001:2015 FISH with digital fluorescence scoring	Manual FISH scoring, possible inter‑observer variability
Speed / TAT	7 working days	10–14 working days
Accreditation	DHA‑licensed, ISO certified	May lack formal accreditation

Physician Insight & Safety Protocols

“As a specialist in diagnostic radiology engaged in oncology diagnostics, I understand the critical need for accurate HER2 status determination. This FISH test provides the definitive evidence required to personalize breast cancer treatment. Please contact our team to discuss your results before making any clinical decisions.” – Mr. Prabhakar Reddy Kalathoor, Specialist Diagnostic Radiology, DHA ID: 61713011

Medication Warning

Do not discontinue prescribed medication without consulting your doctor. Always speak to your treating physician before altering any therapy based on test results.

Exclusion Criteria & Emergency Red Flags

Tissue block with less than 10% invasive tumor cellularity.
Decalcified or excessively fixed specimens that degrade DNA integrity.
Sample older than 1 month without verification of DNA integrity.
Emergency Red Flag: If significant necrosis or poor preservation is noted, the test may be rejected. Contact the lab immediately for guidance.

Sample Collection & Pre‑Test Instructions

Hospital Extraction Only – Sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety. Submit Formalin‑Fixed Paraffin‑Embedded (FFPE) tissue block shipped at room temperature via Secure Medical Courier Solid Tissue Specimen Retrieval. The block must contain at least 10% invasive tumor tissue. A duly filled Chromosome & FISH Analysis Requisition Form (Form 17) is mandatory. Our logistics team will coordinate the secure retrieval.

Patient FAQ & Clinical Guidance

1. What does an equivocal HER2 IHC result mean and why do I need FISH?

An equivocal HER2 IHC (2+) means borderline protein expression; FISH definitively determines gene amplification to guide targeted therapy. Invasive breast cancer with 2+ staining by immunohistochemistry requires reflex FISH testing per ASCO/CAP guidelines. Only FISH can differentiate true amplification from polysomy 17 or other causes, ensuring appropriate use of HER2‑directed agents.

2. How long does the FISH‑HER2 test take and will my treatment be delayed?

Our ISO‑accredited lab delivers results within 7 working days, minimizing any treatment delay while ensuring clinical accuracy. The FISH procedure runs on optimized digital platforms; once the block is received, pre‑analysis quality checks and hybridization are completed rapidly, keeping your oncology team informed throughout.

3. Is home collection available for the tissue block sample?

No. As an archival tissue specimen, the FFPE block must be retrieved directly from the hospital pathology department where it is stored. DNA Labs UAE provides a Secure Medical Courier Solid Tissue Specimen Retrieval service to seamlessly transfer the block from your treating hospital to our ISO‑accredited laboratory. A trained courier will handle the specimen according to strict biosafety and chain-of-custody standards.

4. How does DNA Labs ensure the integrity of my tissue sample during transport?

Our Secure Medical Courier Solid Tissue Specimen Retrieval service utilizes temperature-controlled packaging and chain-of-custody protocols to ensure the FFPE block reaches our lab in optimal condition for accurate FISH analysis. This rigorous process guarantees the preservation of DNA integrity required for precise ERBB2 gene amplification scoring.

UAE Regulatory & Data Privacy Adherence

DNA Labs UAE operates in full compliance with Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) and Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields. All patient data, including genetic and molecular information, is processed with strict confidentiality and security protocols. Clinical procedures and patient consent follow the standards outlined in Federal Decree-Law No. 4 of 2016 on Medical Liability.

Clinical & Logistical Metadata

Attribute	Value
Test Name	FISH‑HER2 (ERBB2) Reflex Assay
Price (AED)	1,500 AED
Turnaround Time	7 working days
Sample Type / Matrix	Formalin‑Fixed Paraffin‑Embedded (FFPE) Tissue Block
Methodology Used	Fluorescence In Situ Hybridization (FISH), Digital Scoring
ICD-10-CM Code	C50.9
LOINC Code	32833‑0
DHA Facility License & Address	1143 \| Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE