Oncology
Colorectal & Pancreatic ctDNA
Liquid biopsy assay for circulating tumour DNA in colorectal and pancreatic oncology.
Format
Multiplex real-time PCR
Manufactured in
Jeddah · KSA
Quality system
ISO 13485 aligned
GMP
WHO GMP aligned
Overview
The Gene Matrix Colorectal & Pancreatic ctDNA assay is a real-time PCR-based liquid biopsy designed to detect circulating tumour DNA from plasma — supporting non-invasive monitoring in colorectal and pancreatic oncology pathways. The assay focuses on clinically actionable molecular markers established in international oncology guidelines.
Clinical Context
- Colorectal cancer is among the most diagnosed cancers in the Kingdom; pancreatic cancer carries one of the highest mortality rates and benefits from sensitive non-invasive monitoring.
- ctDNA-based liquid biopsy enables disease monitoring without repeat tissue sampling — particularly valuable in difficult-to-biopsy tumours such as pancreatic cancer.
- A locally manufactured ctDNA assay supports oncology centres of excellence in Saudi Arabia and reduces dependency on overseas reference laboratories.
Assay Profile
| Parameter | Detail |
|---|---|
| Indications | Colorectal carcinoma · Pancreatic carcinoma |
| Sample type | Plasma (cell-free DNA) |
| Targets | Clinically actionable molecular markers (panel under finalisation) |
| Format | Real-time PCR-based liquid biopsy |
| Status | Manufacturing under GMP — speak to our team for validation data |
Workflow
From sample to result, in four steps
- 01
Sample collection
Validated transport medium and sample types per assay specification.
- 02
Nucleic acid extraction
Compatible with major automated and manual extraction workflows.
- 03
Real-time PCR
Multiplex amplification on standard 96-well thermocyclers.
- 04
Reporting
Genotype/serotype-specific channels for clear clinical reporting.
Performance
Validated to international references
Each assay is characterised for analytical sensitivity, specificity and limit of detection against established clinical references. Full validation packs and lot-specific data are shared with prospective customers under appropriate confidentiality.
Analytical sensitivity
Validated against international reference panels
Analytical specificity
No cross-reactivity with related pathogens
Limit of detection
Lot-specific data on request
Frequently asked
Is the assay intended for screening or for monitoring?
The current intent is non-invasive monitoring of colorectal and pancreatic oncology pathways, with focus on clinically actionable markers.
What plasma volume is required?
Standard cfDNA plasma volumes apply. Specific volume requirements are confirmed in the kit's instructions for use.
Can performance data be shared?
Yes — validated performance data is shared with prospective oncology partners under appropriate confidentiality.