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prime DX®
Precision Individualized Medicine

The new prime DX® technology for molecular tumor profiling is compatible with both FFPE and PLASMA!

Prime DX is designed to give to the physician an overall outlook on treatment response for:: .

  • • Targeted therapy
  • • Immunotherapy
  • • Chemotherapy

It is one of the most detailed, sensitive and accurate tests for imaging tumour biology, allowing the physician to design an effective personalised treatment plan for the patient, including immunotherapy, PARP inhibitors, chemotherapy and the compatibility of participation in clinical studies. 

 

Finally, it provides answers about the toxicity of chemotherapy drugs such as 5-FU, irinotecan, and other chemotherapy drugs and other. .

  • Targeted therapy
  • Immunotherapy
  • Chemotherapy
It is one of the most detailed, sensitive and specific tests for tumor biology configuration, enabling physicians to plan an efficient treatment for the patient, including 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.

The test can be used in the following cases:
  • Aggressive tumors with no standard treatment (e.g. pancreatic cancer)
  • When the initial treatment plan has been completed but more treatment options must be taken under consideration
  • Rare tumors
  • Second-line treatment
  • Tumors of unknown primary tumor
  • Tumors without an established “gold standard”
  • Tumors with several available treatment options where the physician must decide which one will be the most effective on a particular patient (such as lung cancer).
In addition,
  • For a clear indication of the patient's immune response to let the physician know if an immunotherapy plan would be beneficial and/or in order to create the most effective immunotherapy plan.

Why should I choose prime DX®?

Choosing the most appropriate treatment: Polygenic 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, 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 doctor 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. Both 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. It also 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.

RESULTS REPORT

The results of the prime DX® analysis include a detailed explanation of all findings, including the following information.
  • Molecular profiling of the tumor tissue with details on specific gene mutations and interactive access to information related to the specific gene

  • Suggested approved therapies that can be of great benefit to the specific patient with interactive access to clinical studies.

  • Suggested approved therapies that can be of great benefit to the specific patient with interactive access to clinical studies.

  • Suggested investigational 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.

Technical characteristics of prime DX® Test

The new prime DX® test is based on advanced enrichment technology through hybridization probes of target genomic regions. It also 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 tumour-associated genes and gene rearrangements/fusions in 38 genes.
Analyses biomarkers for immunotherapy response, including HLA detection and biomarkers for chemotherapy response.

The MGI-DNBSEQ-G400 is a CE-IVD platform that enables simultaneous processing of multiple samples with high sensitivity and specificity, producing faster, reliable results at a lower cost

 

Frequently Asked Questions
Doctors

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 we need a paraffin block containing the tumour tissue. We need one paraffin block or four 3 µm paraffin sections: in positive charged slides (air dried at room temperature, not baked), placed on top of the slide, without folds and six unstained slides of 10μm.

For the prime DX Liquid® analysis we need blood in special vials that you will receive from Genekor. (Cell-Free DNA BCT®(10ml) και Cell-Free RNA BCT®(10ml)).

Why is it necessary to analyse so many genes?

  • Quantity and quality of information
  • Reduced time
  • Reduced costs

As more and more targeted therapies target gene changes detected in a small number of patients, a multi-gene panel results in the generation of a large amount of multi-level information of useful value greatly increasing the likelihood of finding a personalized treatment plan for the patient.

It has also been shown that the more genes analysed, the more reliable the results for TMB.

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 new prime DX Liquid® test also consists of a 1021 gene panel, which analyses the two immunotherapy biomarkers MSI and TMB. It also includes Loss of Heterozygosity (LOH) analysis, which can be used as a biomarker for treatment with PARP inhibitors, . This enables the physician to plan an effective treatment for the patient, including immunotherapy, chemotherapy, PARP inhibitors and patient participation in clinical trials when required.

Is a rebiopsy recommended or a material from a previous biopsy can be suitable?

It is preferable to analyse tissue by rebiopsy if available or prime Liquid DX®. A previous biopsy tissue is inappropriate in cases where the patient has received targeted therapy since the previous biopsy.

Why should I sign the consent form?

For the use of the patient’s genetic material for testing, ELOT EN ISO9001:2008 and ELOT EN ISO15189:2012 require the written consent of each patient.

Are there any special transportation conditions?

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.

For specific guidelines for the collection of the prime DX Liquid® blood sample click here for more information.

Is the test covered by any public/private insurance?

For information about the cost coverage of the test you should contact your insurance company.

How do I make the payment for the test?

Payment can be made by bank transfer or debit/credit card.

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 are shared with your GP via email.

Frequently Asked Questions
Patients

How to order the test?

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.

If you want to send us your sample, please contact us in order to arrange all procedures.
CONTACT

*For more information on scientific content please contact: scientific.support@genekor.com

Download the promotional brochure here.