For an effective personalized
cancer treatment plan
Prime DX® is an advanced assay for comprehensive molecular tumor profiling, compatible with both tumor tissue (F FPE ) and blood based liquid biopsy (plasma) .
In today’s era of precision medicine, understanding the genetic alterations that drive cancer is essential for selecting the most appropriate treatment strategy.
prime DX® testing provides clinically actionable insights that help physicians identify potential therapeutic options tailored to each patient’s tumor biology, including:
By delivering a broad molecular profile from a single test, prime DX® supports informed, individualized treatment decisions across multiple therapeutic pathways.
prime DX® provides broad molecular profiling via a 1021 gene NGS (Next Generation Sequencing) panel 1021 panel combined with exome RNA sequencing, enabling comprehensive tumor characterization .
prime DX® enables simultaneous assessment of multiple clinically relevant biomarkers:
prime DX® now combines comprehensive DNA analysis (1021 genes) with
exome RNA sequencing targeted capture, enabling a more complete and clinically meaningful
characterization of tumor profiles.
DNA sequencing identifies single nucleotide variants (SNVs),
insertions/deletions (indels), copy number variations (CNVs), and selected
structural rearrangements, while RNA sequencing enables the direct detection of
expressed gene fusions and splicing events.
This integrated approach significantly enhances the sensitivity and specificity
of fusion detection, particularly in cases where genomic breakpoints are complex, intronic, or not adequately
covered by DNA-based methods.
Also,
With the integration of Homologous Recombination Deficiency (HRD) analysis into clinical decision-making, physicians can:
The new prime DX® test offers HRD analysis through both the detection of BRCA1/2 or other HRR gene mutations, as well as the assessment of genomic instability (Rediscore®).
This comprehensive NGS approach provides an integrated evaluation of both Comprehensive Genomic Profiling (CGP) and HRD status in a single assay.
It represents a significant advancement compared to most available tests that focus solely on HRD assessment, and contributes to a more complete molecular characterization of the tumor.
| ATM | ATR | ATRX | BAP1 | BARD1 | BLM | BRCA1 | BRCA2 | BRIP1 | CDK12 |
| CHEK1 | CHEK2 | C11orf30 | ERCC1 | FAM175A | FANCA | FANCC | FANCD2 | FANCE | FANCF |
| FANCG | FANCL | FANCM | MRE11 | NBN | PALB2 | RAD50 | RAD51 | RAD51B | RAD51C |
| RAD51D | RAD52 | RAD54L | RECQL | RECQL4 | WRN |
Broader Applications
Although the use of HRD (Homologous Recombination Deficiency) as a biomarker is most well established in
ovarian cancer, it is increasingly being applied across a broader range of tumor types, including:
• Breast cancer
• Pancreatic cancer
• Prostate cancer
HRD assessment supports the selection of targeted therapeutic strategies,
enhancing the implementation of precision oncology across multiple indications.
Note:
Additional tumor types may be evaluated upon initial request.
By focusing on the expressed transcriptome, RNA sequencing confirms the functional relevance of detected alterations, reducing false-positive and false-negative results and enhancing confidence in clinical interpretation.
The assay targets coding regions across more than 20,000 genes and over 69,000 transcripts, including partial coverage of UTR regions, ensuring broad and accurate detection of clinically relevant gene fusions.
The RNA component is specifically optimized for challenging clinical samples, such as FFPE-derived material, ensuring robust performance in routine diagnostic settings where sample quality may be limited.
It maintains high performance even with low-input or degraded RNA, delivering reliable and reproducible results.
RNA analysis through prime DX® enables high-sensitivity detection of
gene fusions and transcriptomic alterations, supporting both
therapeutic decision-making and accurate diagnosis.
The addition of RNA sequencing provides important advantages in patient management:
State-of-the-Art Testing Platforms: Utilizing advanced Next-Generation Sequencing (NGS) technologies, in combination with
commercially available and proprietary bioinformatics tools, our integrated testing approach ensures accurate, reliable, and comprehensive data.
Experienced Scientific Team: Our team consists of specialized molecular scientists who translate genomic data into clinically actionable insights, supporting and optimizing personalized therapeutic approaches.
Two Perspectives, One Powerful Profile: Combining tissue and liquid biopsy for precision care.
The prime DX® assay is performed in a CAP-accredited laboratory, while the analysis of selected genes and biomarkers falls within the scope of accreditation according to ISO 15189:2022.
Next-Generation Sequencing (NGS) is performed using the MGI DNBSEQ-T7 and MGI DNBSEQ-G400 platforms, which, along with the reagents used, are CE-IVD, ensuring high sensitivity and specificity in multi-sample processing.
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
Genekor ensures a high level of quality, reliability, and security through internationally recognized accreditations and certifications.
*Within the official scope of accreditation.
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.
Frequently Asked Questions
Patients
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.