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Test Price

1,200 AED

✅ Home Collection Available

PIK3CA Mutation Analysis (Exon 7, 9 & 20) – Precision Oncology Guidance

Executive Summary & Core Metrics

  • 99.9% diagnostic accuracy – ISO-certified Sanger sequencing with single-nucleotide resolution.
  • Turnaround time: 7–8 working days from sample receipt.
  • Price: 1,200 AED (all-inclusive, no hidden charges).
  • Sample type: Archival tissue specimen (FFPE block or biopsy slides) – Secure Medical Courier Solid Tissue Specimen Retrieval.
  • Post-result teleconsultation with a board-certified genetic counsellor.
  • Insurance pre-approval support via WhatsApp: +971 54 548 8731.

Test Overview & Methodology

The PIK3CA Mutation Analysis identifies somatic alterations in exons 7, 9, and 20 of the PIK3CA gene. This test is essential for guiding precision oncology in breast, endometrial, and other PIK3CA-related cancers. Our laboratory employs Sanger sequencing (ISO 9001:2015 certified) to deliver robust, single‑nucleotide resolution results.

Feature Our Test (ISO 9001:2015) Alternative Approach
Precision Single‑nucleotide resolution, >99.5% analytical specificity Broad NGS panels; may miss low-level variants
Method Sanger Sequencing (CAP/CLIA‑aligned, validated for hot‑spot exons) Next‑Generation Sequencing (requires orthogonal confirmation)
Speed 7–8 working days from sample receipt 10–14 days typical

Physician Insight & Safety Protocols

“From Dr. Lina Osama Zaki Quteineh (Consultant Medical Genetics, DHA License: 9294403): As a consultant medical geneticist, I emphasise that PIK3CA mutation testing should always be interpreted alongside comprehensive clinical and imaging workup. Never modify your treatment based solely on this result; always consult your treating oncologist for individualised guidance. We are here to support you at every step.”

Medication Advisory

Do not discontinue any prescribed medication without consulting your doctor. This test does not replace clinical judgement or ongoing therapy.

Patient Safety Exclusion & Emergency Flags

  • Exclusion criteria: Patients unable to provide informed consent; known contraindications to tissue biopsy (e.g., severe coagulopathy).
  • Post-biopsy red flags: Excessive bleeding, fever >38°C, or severe pain/swelling at the biopsy site – seek immediate medical care.
  • Collection protocol: Hospital Extraction Only – Sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety.

Patient FAQ & Clinical Guidance

1. What is PIK3CA mutation analysis used for?

PIK3CA mutation analysis identifies specific somatic genetic changes in tumor tissue to guide targeted therapy and prognosis. This test is particularly relevant for breast cancer, endometrial cancer, and PIK3CA‑related overgrowth syndromes. The result helps oncologists select therapies such as PI3K inhibitors when appropriate.

2. How is the test performed and what is the turnaround time?

You provide a tumor tissue sample (via biopsy or archival FFPE block) that is analysed using Sanger sequencing, with results in 7–8 working days. Our ISO‑certified lab processes the sample under strict cold‑chain conditions. A doctor’s prescription is required for tissue collection, except for surgery/pregnancy/travel‑abroad cases as per UAE regulations.

3. Is this covered by insurance in the UAE?

Most UAE insurers cover PIK3CA mutation analysis when pre‑authorised and accompanied by a valid medical referral. We provide direct billing verification via WhatsApp at +971 54 548 8731. Coverage depends on your policy and clinical necessity; we assist with pre‑approval documentation aligned with DHA circulars and UAE data privacy regulations.

4. What are the risks and limitations of the test?

The test requires a tissue biopsy, which carries inherent risks such as bleeding or infection. Results should always be interpreted in the context of full clinical and radiological findings. A negative result does not rule out the presence of other actionable mutations.

UAE Regulatory & Data Privacy Adherence

Our laboratory complies fully with:

  • Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) – ensuring your genetic data is processed securely and lawfully.
  • Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields – covering electronic health data handling.
  • Federal Decree-Law No. 4 of 2016 on Medical Liability – governing clinical test safety and patient consent.
  • ISO 9001:2015 certification (Cert: INT/EGQ/2509DA/3139) and DHA Facility License 1143.

Your sample and results are protected under the highest standards of medical confidentiality and data security.

Clinical & Logistical Metadata

Test Name PIK3CA Mutation Analysis (Exon 7, 9 & 20)
Price (AED) 1,200 AED
Turnaround Time 7–8 working days
Sample Type / Matrix Archival tissue specimen (FFPE block, biopsy slides, or surgical pathology cuts) – Secure Medical Courier Solid Tissue Specimen Retrieval
Methodology Used Sanger Sequencing (ISO 9001:2015, CAP/CLIA‑aligned)
ICD-10-CM Code C50.9 (Malignant neoplasm of breast, unspecified), C54.1 (Malignant neoplasm of endometrium)
LOINC Code 81253-0 (PIK3CA gene mutations found [Identifier] in Tumor)
DHA Facility License & Lab Address DHA License 1143 | Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE | Corporate Lab: DNA Labs UAE

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