Prime DX Solid/ Liquid/ combo
Prime DX® – Molecular tumor profiling by liquid biopsy
Precision Individualized Medicine
The new prime DX® technology for molecular tumor profiling is compatible with both FFET and PLASMA and in combination (COMBO)for more holistic analysis
The technology of prime DX® test supports the profile analysis of the tumor both on FFPE tissue and Cell‐free DNA in blood.
Prime DX® is designed to give to the physician an overall outlook on cancer treatment response for:
- Targeted therapies
- Immunotherapy
- Chemotherapy
This test offers exceptional sensitivity, and specificity in analyzing the tumor’s biology, helping physicians design effective cancer treatment plans. It supports decisions on targeted therapies, immunotherapy, chemotherapy, PARP inhibitors, and the patient’s suitability for participation in clinical trials. Also, it provides insights into potential toxic reactions to chemotherapy drugs like 5-FU, irinotecan, and more.
The test can be used in the following cases:
- Aggressive tumors with no standard treatment (e.g. pancreatic cancer)
- Tumors of unknown primary tumor
- Second-line treatment
- Tumors without an established treatment
- Tumors with various available treatment options where the physician must conclude on the most efficient on a particular patient (eg. lung cancer).
- To estimate the patient’s general response to immunotherapy or in order to create the most efficient immunotherapy plan.
The test also includes:
Immunotherapy Biomarkers PARP Inhibitors Biomarkers IHC Biomarkers
Agnostic Markers
Gene Panel & Immunotherapy Biomarkers
PDL-1 • TMB • MSI • HLA • LOH
No. of genes: 1021 genes
Target size: 1 Mb
Target regions:
- Whole exomes
4847 exomes of 312 genes - The region of introns, promoters and fusion breakpoints
38 genes: 54 introns region of 26 genes + breakpoints region of 12 genes - Promoters’ region or other non-coding region
TERT, PMS2, BCL2L11 - Coding regions
1778 coding regions of 709 genes
RNA level analysis
RNA WES analysis: Known and unknown fusion partner detection
Why is prime DX® the right choice?
Selecting the most effective treatment plan: The Prime DX® multi-gene analysis offers more actionable insights than any other test currently available. By examining 1.021 cancer-related genes along with key immunotherapy biomarkers—MSI, PD-L1, LOH (specific to ovarian cancer), HLA, and TMB—Prime DX® provides the most comprehensive data to date. This enables physicians to clearly determine which treatments, including immunotherapy, chemotherapy, and PARP inhibitors, are likely to be effective for each patient.
Continuous support to the physician and the patient from our experienced team.
The Prime DX® test goes beyond simply delivering results. Our dedicated customer service team and scientific consultants provide ongoing support to both the physician and patient. From start to finish, we guide patients through the testing journey and offer personalized insights and recommendations for treatment, ensuring a reliable and supportive experience for all involved.
Precision, sensitivity, and reliability:
The Prime DX® test utilizes cutting-edge enrichment technology with hybridization-based detectors targeting specific genomic regions. It also incorporates molecular tracing (UMIs) to enhance the sensitivity of detecting somatic mutations. Thanks to its outstanding reproducibility, accuracy, and specificity, this technology has been embraced by top oncology centers.
The Prime DX® analysis report provides a comprehensive information overview, including:
- The molecular profile of the tumor, highlighting specific gene mutations and offering interactive access to detailed information about each gene.
- A list of approved therapies likely to be effective for the individual patient, along with interactive links to relevant clinical research.
- Recommended, approved cancer treatments tailored to the patient, supported by access to associated clinical trials.
- Investigational therapies that may be beneficial, with links to ongoing or past clinical studies.
- Identification of treatments likely to be ineffective due to resistance, helping avoid non-beneficial treatments.
- Suggested medications that have established indications based on the patient’s genetic profile
Download Sample Results Report
Technical characteristics of prime DX® Test
The new prime DX® test is based on advanced technology using hybridization probes of target genomic regions. Additionally, it uses molecular tracers (UMIs) for increased sensitivity in detecting somatic variants. This technology has shown high reproducibility, sensitivity and specificity and has therefore been adopted by leading oncology institutions worldwide.
The test uses the Oncology Multi-Gene Variant Assay (GenePlus), which is a qualitative in vitro diagnostic test (CE-IVD) that detects variants in 1021 tumor-associated genes and gene rearrangements/fusions in 38 genes.
It also analyzes biomarkers for immunotherapy response, including MSI (Microsatellite Instability), TMB (Tumor Mutational Burden), and HLA zygosity detection and biomarkers for chemotherapy response.
The MGI-DNBSEQ-G400 is a CE-IVD platform that enables the simultaneous processing of multiple samples with high sensitivity and specificity, delivering faster, reliable results at a lower cost.
In the new prime DX® test, the following predictive immunohistochemical markers can be added, performed at our pathology laboratory:
See the result report for prime DX®
See the result report for prime DX® with Immunohistochemistry
According to Dubai regulations and ELOT EN ISO9001:2008 and ELOT EN ISO15189:2012 the written consent of each patient is needed in order to use their genetic material.
The tissue sample for prime DX® should be stored at room temperature (25°C). During the summer period we recommend to have an ice pack in the Kit, which should not directly touch the sample.
The temperature where the tissue sample is stored should not exceed room temperature (25°C). During the summer period we advise to have an ice pack in the Kit, which should not directly touch the sample.
For specific guidelines for the prime DX Liquid ® blood sample drawing click here.
Payment methods available are via bank transfer or debit/credit card.
To schedule collection and return of your sample, please contact us
Your results are shared with your GP via email.
Please contact Scipharm’s customer service for test ordering and assistance.
