Test Price
6,000 AED✅ Home Collection Available
TP53 Mutation Analysis (NGS) in UAE – 6,000 AED
Executive Summary & Core Metrics
Key Performance Indicators
- Accuracy Guarantee: 99.9% diagnostic sensitivity via ISO 9001:2015 accredited NGS processing with orthogonal Sanger confirmation for all pathogenic and likely pathogenic variants.
- Clinical Logistics: Hospital extraction required – sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety due to the invasive specimen requirements.
- Post‑Test Support: Complimentary telephonic consultation with a consultant medical geneticist to interpret results and guide clinical decision‑making.
- Insurance Verification: Direct billing confirmation available via WhatsApp at +971 54 548 8731.
This assay detects germline and somatic variants in the TP53 tumour suppressor gene, providing critical risk stratification for Li‑Fraumeni syndrome and hereditary cancer predisposition. Turnaround time is 15–18 business days from sample receipt.
Test Overview & Methodology
TP53 Mutation Analysis by Next‑Generation Sequencing (NGS) delivers comprehensive coverage of all coding exons and flanking splice‑site regions of the TP53 gene, the most frequently mutated tumour suppressor in human cancer. This DHA‑compliant assay detects single‑nucleotide variants (SNVs), small insertions and deletions, and copy‑number alterations with 99.9% analytical sensitivity. Results are classified according to ACMG/AMP guidelines and confirmed by Sanger sequencing for all clinically actionable calls, ensuring precision oncology decision‑making for patients in the UAE.
| Feature | Our Test – NGS TP53 Analysis | Closest Alternative – Single‑Gene Sanger |
|---|---|---|
| Technology | High‑coverage NGS (Illumina) with confirmatory Sanger for all pathogenic calls | Sanger sequencing of selected exons only |
| Analytical Sensitivity | 99.9% for SNVs, small indels, and copy‑number changes | ~99% for point mutations; poor detection of large rearrangements |
| Turnaround Time | 15–18 business days | 7–10 days (incomplete region analysis) |
| Clinical Relevance | Covers all ACMG‑recommended regions; Li‑Fraumeni syndrome & somatic profiling | Limited to hotspot exons; may miss clinically actionable mutations |
Physician Insight & Safety Protocols
"Interpreting a TP53 variant requires careful correlation with the patient's personal and family oncological history. This NGS assay offers comprehensive coverage that can identify clinically actionable mutations, but results must always be contextualised within a complete genetic counselling framework. I encourage patients to discuss all findings with their referring oncologist and a board‑certified genetic counsellor before making any decisions about surveillance or preventive measures."
– Lina Osama Zaki Quteineh, Consultant Medical Genetics, DHA Registration ID: 9294403
⚠ Important Safety Advisory
Never alter or discontinue any prescribed medication without explicit direction from your treating physician. This genetic test is a diagnostic and risk‑assessment tool and does not replace ongoing clinical management.
Exclusion Criteria & Emergency Red Flags
- Pregnancy: requires prior specialist genetic counselling and written informed consent in accordance with Federal Decree‑Law No. 4 of 2016 on Medical Liability.
- Acute febrile illness or recent blood transfusion (less than 2 weeks) may compromise sample quality and result accuracy.
- Incomplete or absent consent for genetic data storage under Federal Decree‑Law No. 45 of 2021 on Personal Data Protection (PDPL) – mandatory for all minors.
- Seek immediate medical attention if you experience sudden severe bleeding, neurological changes, or intense pain unrelated to the blood draw; these are not test complications but require urgent clinical evaluation.
Patient FAQ & Clinical Guidance
1. What is TP53 mutation analysis and why is it performed?
It detects inherited or acquired mutations in the TP53 tumour suppressor gene, essential for diagnosing Li‑Fraumeni syndrome and guiding cancer surveillance. The test analyses all coding exons using NGS, providing a definitive genetic risk assessment for multiple malignancies including breast, brain, adrenal, and soft‑tissue sarcomas. Results are reported with ACMG‑based classification to support personalised risk management.
2. How is the sample collected for this test?
Sample collection is performed exclusively within an accredited hospital setting. A peripheral blood draw or bone marrow aspirate is obtained by qualified clinical staff under sterile conditions. The specimen is immediately placed into a temperature‑controlled cold‑chain transport system and delivered to the ISO‑certified laboratory within 4 hours. No fasting or special preparation is required.
3. When will I receive my results and how should they be interpreted?
Your comprehensive report is ready in 15–18 business days and includes a complimentary telephonic consultation with a consultant medical geneticist. Results are classified according to ACMG/AMP guidelines; pathogenic and likely pathogenic variants are explained in the context of your personal and family history, with clear recommendations for surveillance and preventive care. Benign variants are also reported for completeness.
UAE Regulatory & Data Privacy Adherence
Legal & Privacy Compliance Framework
This diagnostic service operates under the regulatory oversight of the Dubai Health Authority (DHA) and fully adheres to the following UAE federal legislation:
- Federal Decree‑Law No. 45 of 2021 on Personal Data Protection (PDPL) – governing the collection, processing, and storage of personal health data.
- Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields – regulating electronic health records, telemedicine, and digital genetic data transmission.
- Federal Decree‑Law No. 4 of 2016 on Medical Liability – ensuring patient consent, clinical safety, and professional accountability in diagnostic procedures.
All genetic data is stored on encrypted servers within the UAE, and identifiable information is never shared with third parties without explicit written patient consent. Patients may request data deletion in accordance with PDPL Article 9 at any time.
Clinical & Logistical Metadata
| Test Name | TP53 Mutation Analysis (Next‑Generation Sequencing) |
| Price (AED) | 6,000 |
| Turnaround Time | 15–18 business days |
| Sample Type / Matrix | Hospital Extraction Only – Sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety. Acceptable matrices: peripheral blood (EDTA whole blood) or bone marrow aspirate. |
| Methodology Used | Next‑Generation Sequencing (Illumina platform) with orthogonal Sanger confirmation for all pathogenic and likely pathogenic variants; bioinformatic analysis for SNVs, indels, and copy‑number alterations |
| ICD‑10‑CM Code | Z15.09 (Genetic susceptibility to other malignant neoplasm) |
| LOINC Code | 21647-9 (TP53 gene mutation analysis in Blood or Tissue by Molecular genetics method) |
| DHA Facility License & Address | DHA Facility License Number: 1143 – Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE. Corporate Lab Branding: DNA Labs UAE. |
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All reports reviewed by DHA-Certified physicians