HER2/neu DNA Detection & Quantification (RNA Detection) Qualitative Test 1,400 AED

Executive Summary & Core Metrics

High-precision molecular assay for HER2/neu gene amplification.

Methodology: Real-time quantitative PCR (RT‑qPCR) with 99.9% sensitivity.
Sample Type: Archival tissue (FFPE blocks/slides) or fresh biopsy; home phlebotomy not available.
Turnaround Time: 3 working days from receipt of specimen.
Price: 1,400 AED inclusive of courier and reporting.
Clinical Utility: Guides anti‑HER2 targeted therapy (e.g., trastuzumab, pertuzumab).

Test Overview & Methodology

This validated molecular assay detects and quantifies ERBB2 (HER2/neu) gene amplification at both DNA and RNA levels using real‑time PCR. It offers superior sensitivity compared to traditional FISH, enabling identification of low‑level amplifications that may otherwise be missed. The result is reported as an amplification ratio with a binary qualitative interpretation (amplified / not amplified) and is essential for determining eligibility for targeted therapy in breast, gastric, and other solid tumors.

Feature	DNA Labs UAE – HER2 qPCR	Alternative: FISH
Methodology	Real‑Time PCR (qPCR) + optional WGS	Fluorescence In Situ Hybridization
Sensitivity	99.9% (detects low‑level amplification)	~95%
Turnaround Time	3 working days	5–7 days
Price	1,400 AED	~1,600 AED

Physician Insight & Safety Protocols

“As a specialist diagnostic radiologist involved in oncologic assessment, I consider quantitative HER2 PCR an invaluable tool for treatment stratification. Its ability to detect borderline amplifications advances precision oncology, but results must always be integrated with full histopathology and clinical staging.”

— Mr. Prabhakar Reddy Kalathoor, Specialist Diagnostic Radiology, DHA Registration ID: 61713011

Advisory: Medication Continuity

Important: Never discontinue or modify prescribed therapy based solely on test results. Always consult your treating physician before making any changes to your medication regimen.

Patient Safety: Exclusion Criteria & Emergency Red Flags

Exclusion Criteria: Inadequate or unlabeled tissue specimen; inability to provide informed consent; known bleeding diathesis contraindicating tissue biopsy collection.
ER Red Flags: If you experience excessive bleeding, sudden swelling, severe pain, or signs of infection at the collection site, seek immediate emergency care.

Patient FAQ & Clinical Guidance

1. What does this test detect?

This real‑time PCR‑based assay identifies amplification of the ERBB2 (HER2/neu) gene in tumor tissue (DNA and RNA). A positive result indicates eligibility for anti‑HER2 targeted therapy such as trastuzumab; a negative result helps avoid unnecessary treatment toxicity.

2. How is the sample collected and processed?

The specimen is an archival tissue block (FFPE) or a fresh biopsy obtained during a hospital‑based procedure. Our secure medical courier retrieves the solid tissue specimen under controlled conditions. Home phlebotomy is not available for this test. Processing begins within 24 hours of receipt at the laboratory.

3. What do my results mean, and what are the next steps?

A positive amplification result generally qualifies you for targeted anti‑HER2 therapy. A negative result suggests conventional chemotherapy regimens are more appropriate. Always review your report with your oncologist, who will correlate the findings with your IHC score, tumor stage, and overall clinical picture. Our clinical team provides a telephonic guidance session to explain the report and coordinate with your treating physician.

UAE Regulatory & Data Privacy Adherence

This diagnostic service 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. Clinical safety and informed consent procedures adhere to Federal Decree‑Law No. 4 of 2016 on Medical Liability. All testing is performed in a DHA‑licensed facility (License No. 1143) holding ISO 9001:2015 certification.

Clinical & Logistical Metadata

Test Name	HER2/neu DNA Detection & Quantification (RNA Detection) Qualitative Test
Price (AED)	1,400 AED
Turnaround Time	3 working days
Sample Type / Matrix	FFPE tissue blocks or slides, fresh biopsy
Methodology Used	Real‑Time Quantitative PCR (RT‑qPCR)
ICD-10-CM Code	C50.9 (Malignant neoplasm of breast, unspecified); Z03.8 (Observation for suspected condition) as secondary
LOINC Code	48666-4 (HER2/neu gene targeted mutation analysis in Blood or Tissue)
DHA Facility License & Laboratory Address	License No. 1143 \| Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE – DNA Labs UAE