Test Price
2,800 AEDโ Home Collection Available
CLN8 Gene Neuronal Ceroid Lipofuscinosis Type 8 (NCL8) Genetic Test in UAE
Executive Summary & Core Metrics
- Accuracy Guarantee: 99.9% Diagnostic Sensitivity via ISO 9001:2015 Certified NGS processing (Cert: INT/EGQ/2509DA/3139).
- Premium Logistics: VIP Mobile Phlebotomy & Temperature-Controlled Cold-Chain Home Collection (Daily 8 AM โ 11 PM).
- Clinical Guidance: Complimentary Post-Test Genetic Counselling by a DHA-licensed Consultant Medical Genetics professional.
- Insurance: Direct Billing Verification via WhatsApp: +971 54 548 8731. Pre-approval coordinated with all major UAE insurers.
Test Overview & Methodology
This advanced Next-Generation Sequencing (NGS) assay analyzes the entire CLN8 gene coding region, intron-exon boundaries, and deep intronic segments to detect pathogenic variants associated with Neuronal Ceroid Lipofuscinosis type 8 (NCL8), a rare autosomal recessive lysosomal storage disorder causing progressive neurodegeneration. The test provides full gene coverage for single nucleotide variants, small insertions/deletions, and copy number variations. Accepted specimen types include whole blood, extracted DNA, or a single dried blood spot on an FTA card. A mandatory pre-test genetic counselling session is required to construct a detailed pedigree chart and review all relevant neurology reports, MRI findings, and prior genetic test results. This session is included in the service and must be completed before sample collection.
| Feature | Our CLN8 NGS Test | Closest Alternative (Sanger Sequencing) |
|---|---|---|
| Target Coverage | Full gene sequencing (all exons, intron-exon boundaries, deep intronic regions) | Selected exons only |
| Variant Detection | Single nucleotide variants, small indels, copy number variations (CNVs) | Limited to SNVs and small indels; may miss CNVs |
| Turnaround Time | 3โ4 weeks | 4โ6 weeks (if targeted) |
| Clinical Utility | Diagnostic confirmation, carrier screening, family planning | Primarily diagnostic confirmation |
Physician Insight & Safety Protocols
Consultant Medical Genetics Lina Osama Zaki Quteineh (DHA Registration ID: 9294403) shares: โGenetic testing for CLN8-related NCL8 provides families with a definitive molecular diagnosis, enabling targeted therapeutic planning and informed reproductive decision-making. Results should always be interpreted in conjunction with comprehensive clinical evaluation, detailed family history, and neurological assessment.โ
Medication Advisory
Continue all prescribed therapies, including anticonvulsant and neuroprotective regimens, unless explicitly directed otherwise by your managing neurologist. Genetic testing serves as a diagnostic adjunct and does not replace or modify existing clinical care protocols. Do not discontinue any medication without direct consultation with your treating physician.
Patient Safety Exclusion Criteria & Emergency Indicators
- Exclusion: Testing is not indicated for asymptomatic minors without parental consent per UAE Federal Law No. 2 of 2019; a mandatory genetic counselling session must precede sample collection.
- Exclusion: Patients with recent blood transfusion (within 2 weeks) or active bone marrow transplantation should defer testing due to potential alteration of circulating DNA profiles.
- URGENT: Acute vision loss, uncontrolled seizures, or rapid cognitive decline requires immediate emergency evaluation; genetic testing must not delay acute medical intervention.
- Home phlebotomy is suspended for individuals with active febrile illness or confirmed COVID-19; reschedule upon complete recovery.
Patient FAQ & Clinical Guidance
1. What is the clinical significance of a positive CLN8 NGS result for my child's diagnosis?
A positive result confirms the presence of a disease-causing variant in the CLN8 gene, establishing a molecular diagnosis of neuronal ceroid lipofuscinosis type 8. This enables accurate prognosis, targeted therapeutic monitoring, and informed family planning including recurrence risk assessment for future pregnancies.
2. Is the CLN8 genetic test covered by health insurance in the UAE?
Yes, most UAE insurers cover the CLN8 genetic test when deemed medically necessary with a physician referral. Our team manages direct billing and pre-approval verification via WhatsApp at +971 54 548 8731. A clinic referral letter and physician order are required to initiate the approval process.
3. How does the home collection process ensure sample integrity for DNA testing?
Our ISO-certified temperature-controlled cold-chain phlebotomy service maintains specimen integrity at 2โ8ยฐC from collection to laboratory delivery. The FTA card method provides DNA stability for up to 14 days at ambient temperature, achieving greater than 99.9% sample viability for downstream NGS analysis.
UAE Regulatory & Data Privacy Adherence
Regulatory Compliance Framework: This service operates in full compliance with Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL), Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields, and Federal Decree-Law No. 4 of 2016 on Medical Liability. Laboratory processes are certified under ISO 9001:2015 (Cert: INT/EGQ/2509DA/3139). All genetic counselling is delivered by DHA-licensed healthcare professionals registered with the Dubai Health Authority.
Clinical & Logistical Metadata
| Test Name | CLN8 Gene Neuronal Ceroid Lipofuscinosis Type 8 (NCL8) Genetic Test โ Next-Generation Sequencing |
| Price (AED) | 2,800 |
| Turnaround Time | 21โ28 Business Days |
| Sample Type / Matrix | Whole Blood (EDTA), Extracted DNA, or FTA Card Dried Blood Spot |
| Methodology Used | Next-Generation Sequencing (NGS) โ Full Gene Sequencing with CNV Detection |
| ICD-10-CM Code | E75.4 |
| LOINC Code | 94233-3 |
| DHA Facility License & Laboratory Address | DHA License No: 1143 | Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE | DNA Labs UAE |
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All reports reviewed by DHA-Certified physicians