For an effective personalized
cancer treatment plan
Prime DX® is a comprehensive genomic test designed to support personalized cancer treatment through advanced CGP and HRD analysis.
Prime DX® is designed to give to the physician an overall outlook on cancer treatment response for:
It is one of the most detailed, sensitive and specific tests for tumor biology configuration, enabling physicians to plan an efficient cancer treatment for the patient, including targeted therapies, immunotherapy, chemotherapy, PARP inhibitors and clinical trial participation compatibility.
Finally, it gives answers about the toxicity of chemotherapy drugs, such as 5-FU, irinotecan and others. .
prime DX is enhanced with HRD testing (RediScore) for the following four cancer types:
The integration of Genomic Instability analysis (via RediScore) into the HRR gene mutation analysis (Homologous Recombination Repair) enables the identification of additional patients who may benefit from PARP inhibitor therapy or platinum-based chemotherapy.
The enhanced prime DX test provides a comprehensive assessment of both the Comprehensive Genomic Profile (CGP) and the HRD status in a single test.
The incorporation of HRD status into clinical decision-making helps physicians:
The test also includes:
| Immunotherapy Biomarkers | IHC Biomarkers | PARP Inhibitors Biomarkers |
|---|---|---|
| TMB | PD-L1 | HRD |
| MSI | HER2 | |
| HLA | FRα | |
| CLDN18.2 | ||
| c-MET |
| Targeted Therapies | Immunotherapies |
|---|---|
| NTRK1,2,3 | TMB |
| BRAFV600E Mutation | MSI |
| HER2 overexpression | |
| RET Rearrangements | |
| HER2 Overexpression |
Choosing the most appropriate cancer treatment: Multi-gene analysis prime DX® has been shown to more actionable information than any other test. With the analysis 1021 of unique cancer genes and the immunotherapy biomarkers MSI, PD-L1, LOH (for ovarian cancer), HLA και ΤΜΒ, the prime DX® test gives access to the largest amount of actionable information to date, providing the clearest indication to the physician of which targeted therapies will and will not benefit the patient, including immunotherapy, chemotherapy and PARP inhibitors.
Continuous support to the physician and the patient from our experienced team.
The procedure of the prime DX® test or any other test at Genekor Medical S.A. does not end with the notification of the results. Our experienced customer service and scientific consulting teams work with the physician and patient throughout the process. In essence, our teams guide the patient throughout the examination process and provide information and data on recommended treatments on a case-by-case basis, creating a strong support system for both.
Highly accurate, sensitive and reliable technology: The new prime DX® test is based on advanced enrichment technology through hybridisation detectors of target genomic regions. Moreover, 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.
Sequencing is performed using the MGI DNBSEQ-T7 and MGI DNBSEQ-G400 NGS platforms, CE-IVD–certified systems that enable the simultaneous processing of multiple samples with high sensitivity and specificity, delivering faster and more reliable results.
The Prime DX® is accredited by CAP and is accredited according to the ELOT EN ISO 15189:2022 standard, ensuring the highest levels of quality and reliability in biomarker testing, including but not limited to BRCA1/2, EGFR, KRAS, KIT, PDGFRA, FGFR2.
Molecular profiling of the tumor tissue with details on specific gene mutations and interactive access to information related to the specific gene
Recommended approved therapies that can be of great benefit to the specific patient with interactive access to clinical studies
Suggested approved cancer therapies that can be of great benefit to the specific patient with interactive access to clinical studies
Suggested investigational cancer therapies with interactive access to clinical studies
Treatments with associated resistance that will not be of benefit to the specific patient
Medication suggestions with documented indications
The prime DX® test is based on advanced enrichment 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 and MGI-DNBSEQ-T7 CE-IVD platforms allow the simultaneous processing of multiple samples with high sensitivity and specificity, generating faster and more 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:
Which patients are eligible for the test?
All patients with a solid tumor are eligible.
How long does it take to get my results?
15 business days
What kind of sample and how much is required for the test?
For Prime DX® analysis, an FFPE tumor block from the most recent surgical procedure is required, with a tumor content above 20%, excluding bone samples or biopsies with 3–5 cores.
Either the entire block or four 3 μm sections on positively charged slides (air-dried at room temperature, not baked, flat, without folds), as well as six additional unstained 10 μm sections, may be submitted.
Why is it necessary to analyse so many genes?
As an increasing number of targeted therapies are directed toward specific gene alterations detected in a small percentage of patients, the use of an expanded multi-gene panel generates a large volume of high-value clinical information. This significantly increases the likelihood of identifying a personalized therapeutic plan for each patient.
In addition, it has been demonstrated that the higher the number of genes analyzed, the more reliable the calculation of TMB (Tumor Mutational Burden).
In cases where there is not enough tissue or the tissue that is present does not have good quality DNA and/or RNA:
In cases where there is not enough tissue or the tissue that is present does not have good quality DNA and/or RNA, the prime DX® Liquid test is recommended:
The prime DX Liquid® test also consists of a 1021 gene panel and includes the evaluation of immunotherapy biomarkers such as MSI, TMB, and HLA, enabling the treating physician to design an effective treatment plan for the patient, including immunotherapy, chemotherapy, PARP inhibitors, and assessment of eligibility for clinical trials.
Is a rebiopsy recommended or a material from a previous biopsy can be suitable?
Whenever possible, the use of recent tissue or a new biopsy (re-biopsy) is recommended.
Tissue from an older biopsy is considered unsuitable in the following situations:
After targeted therapy
After chemotherapy or immunotherapy
When long periods of time have passed since tissue collection
When the tumor has relapsed or progressed metastatically
When new tissue cannot be obtained, or the available tissue is insufficient in quantity or quality, Prime DX® Liquid is recommended.
Why should I sign the consent form?
GeneKor Medical S.A. follows certified quality and information security systems, which require the written consent of each patient for the use of their genetic material for diagnostic testing.
In addition, written consent is mandatory according to current data protection regulations.
Are there any special transportation conditions?
The sample must be kept at room temperature (25°C).
During the summer period, we recommend including an ice pack in the kit.
The ice pack must not come into direct contact with the samples or accompanying documents.
For specific guidelines for the collection of the prime DX Liquid® blood sample click here for more information.
How do I make the payment for the test?
Our customer service department will provide you with a unique e-banking payment code, or alternatively, payment can be made via credit/debit card or bank transfer.
Is the test covered by any public/private insurance?
For information regarding cost coverage, please contact your insurance provider or our customer service team.
How can I send my sample?
To schedule collection and return of your sample, please contact us.
How will I receive my results?
Your results will be shared with your physician through a secure network, and sent to you via email using a unique, secure access code provided by customer service.
Our Customer Service Team is committed to answer your questions with regards to the services offered by Genekor. If you would like to order any of the tests that Genekor performs please contact us directly.
*To complete the test, you are required to complete and send the Consent form that you will find on the link below.
*For more information on scientific content please contact: scientific.support@genekor.com
Download the promotional brochure here.
*Order in the United Arab Emirates here.