prime DX® Liquid

prime DX® Liquid - Molecular tumor profile in liquid biopsy

The new prime DX® Liquid test consists of a panel of 1021 genes, which analyses the immunotherapy biomarkers TMB, MSI, HLA, allowing the treating physician to plan an effective treatment for the patient, including immunotherapy, chemotherapy, PARP inhibitors and compatibility of participation in clinical trials.

In addition,

prime DX® Liquid, analyses genes involved in genetic predisposition to cancer, thus providing information to the physician about the likelihood of an inherited cancer syndrome.

Recommended for the following cases:

When there is not enough tissue or recent biopsy
If the tissue quality is poor (e.g. too much bone in the sample)
When there is a metastatic and multifocal disease
After treatment to check patient’s response
If the patient relapses and there is a need for molecular profiling without biopsy

Liquid Biopsy - Advantages

Tissue biopsy is the test of choice for testing the molecular profile of the tumor. On the hand, Liquid biopsy is an alternative method in which free circulating genetic material (ctDNA) from the tumour in a blood sample is isolated and tested. All in all, liquid biopsy tests have several advantages, which are:

Non-invasive method (blood sampling)
Possibility of successive analyses – monitoring the progress of the disease
Low failure rate (~3%) due to unsuitability of the material
Better assessment of the genetic heterogeneity of the tumour

RESULTS REPORT

The results of the prime DX® Liquid 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.
Recommended treatments under investigation with interactive access to clinical trials.
Treatments with associated resistance that will not be of benefit to the specific patient.
Medication suggestions with documented indications.

Germline Gene Analysis

prime DX Liquid, also, analyzes genes involved in the genetic predisposition to cancer, giving information to the physician about the probability of a hereditary cancer syndrome.

49 genes analyzed for germline mutations
APC	ATM	ATR	AXIN2	BAP1	BARD1	BLM	BMPR1A	BRCA11	BRCA2
BRIP1	CDH1	CDK4	CDKN2A	CHEK2	EPCAM	FAM175A	FANCA	FANCL	FANCM
GALNT12	HOXB13	MEN1	MITF	MLH1	MRE11	MSH2	MSH3	MSH6	MUTYH
NBN	NF1	NTHL1	PALB2	PMS2	POLD1	POLE	PTEN	RAD50	RAD51B
RAD51C	RAD51D	RET	RNF43	SMAD4	SMARCA4	STK11	TP53	VHL

Technical characteristics of the prime DX® Liquid test

The new Prime DX® Liquid test is based on advanced hybrid-capture enrichment technology with UMIs.
It uses the Circulating Tumor DNA 1021 Gene Variant Assay (GenePlus), a CE-IVD qualitative in vitro diagnostic test that detects variants across 1021 tumor-related genes and gene rearrangements/fusions in 38 genes from liquid biopsy.

It also analyzes immunotherapy biomarkers such as HLA, biomarkers of chemotherapy response, and genes related to hereditary cancer predisposition.

The MGI-DNBSEQ-G400 and MGI-DNBSEQ-T7 CE-IVD platforms enable high-sensitivity, high-specificity processing of multiple samples, delivering faster and more reliable results at a lower cost.

Frequently Asked Questions Physicians

Which patients are eligible for the test?

All patients with a solid tumour when there is insufficient tissue or recent biopsy are suitable.

How long does it take to get my results?

15 business days

What kind of sample and how much is required for the test?

The prime DX Liquid analysis is performed on a liquid biopsy and we need blood in special vials that you will receive from Genekor. (Cell-Free DNA BCT®(10ml).

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).

Are there any special transportation conditions?

The blood sample (liquid biopsy) should be transported in conditions up to 20°C.

Frequently Asked Questions Patients

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.
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 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.
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.

How to order the test?

Our Customer Service Team is committed to answering your questions about the services offered by Genekor. If you are interested in any of the tests offered by Genekor, 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.

CONSENT FORM