prime DX® Liquid

prime DX® Liquid - Molecular tumor profile in liquid biopsy

Having the option to perform prime DX® Liquid on liquid biopsy samples provides a rapid and clinically actionable tool for the treating physician to assess the tumor’s molecular profile and identify the most effective treatment.

In addition,

Genekor’s prime DX® Liquid utilizes a 1021-gene Next-Generation Sequencing (NGS) analysis and leverages an advanced platform that analyzes both cell-free DNA (cfDNA) and DNA extracted from whole peripheral blood.

This approach enables germline testing across 64 genes, while effectively identifying and filtering out CHIP (Clonal Hematopoiesis of Indeterminate Potential)-related mutations, ensuring more accurate and reliable results.

Recommended in the following situations:

Insufficient tissue availability or lack of a recent biopsy
Poor tissue quality (e.g. high bone content in the specimen)
Presence of metastatic and multifocal disease
Post treatment assessment to evaluate patient response
Disease relapse when molecular profiling is required without performing a biopsy

Liquid Biopsy - Advantages

Tissue biopsy is the test of choice for molecular profiling of a tumor. On the other hand, liquid biopsy is an alternative approach in which circulating tumor DNA (ctDNA)—genetic material released from the tumor—is isolated from a blood sample and analyzed. Overall, liquid biopsy offers several advantages, including:

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
Recommended approved therapies based on international clinical guidelines that may particularly benefit the specific patient, with interactive access to relevant clinical trials.
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

in genetic predisposition to cancer, giving information to the physician about the probability of hereditary cancer syndrome. 64 genes analyzed for germline mutations

64 genes analyzed for germline mutations
APC	ATM	ATR	ATRX	AXIN2	BAP1	BARD1	BLM	BMPR1A	BRCA1
BRCA2	BRIP1	CDH1	CDK4	CDKN2A	CHEK2	EPCAM	FAM175A	FANCA	FANCL
FANCM	FH	GALNT12	HOXB13	MEN1	MITF	MLH1	MRE11	MSH2	MSH3
MSH6	MUTYH	NBN	NF1	NF2	NTHL1	PALB2	PMS2	POLD1	POLE
PTEN	RAD50	RAD51B	RAD51C	RAD51D	RB1	RECQL	RECQL4	RET	RNF43
SDHA	SDHB	SDHC	SDHD	SMAD4	SMARCA4	STK11	TP53	TSC1	TSC2
VHL	WRN	WT1	XRCC2

Tumor Fraction (TF) Assessment

prime DX® Liquid now incorporates Tumor Fraction (TF) estimation through an advanced
deep learning approach based on cfDNA fragment size analysis (fragmentomics).

By evaluating the distribution of DNA fragment lengths in plasma, this method provides a
quantitative assessment of circulating tumor DNA (ctDNA), without requiring prior knowledge
of tumor-specific mutations.

This additional layer of information enhances the interpretation of liquid biopsy results,
increases confidence in negative findings, and supports non-invasive monitoring of disease progression over time.

What is Tumor Fraction (TF)?

Tumor Fraction (TF) represents the proportion of tumor-derived DNA relative to the total
cell-free DNA (cfDNA) in plasma.

Higher TF increases the likelihood of detecting tumor-specific variants, while low TF may indicate
limited tumor shedding, early-stage disease, or treatment response.

TF is influenced by tumor biology, disease burden, and
therapy, and should always be interpreted within the appropriate clinical context, in combination with
molecular and other relevant clinical data.

Clinical Utility

Improved result interpretation: Correlates variant findings with ctDNA levels, enhancing confidence in molecular results.
Detection sensitivity awareness: Identifies samples with low tumor content, helping distinguish true negative results from low tumor shedding and reducing the risk of false negatives.
Patient monitoring: Enables longitudinal tracking of Tumor Fraction, providing insights into treatment response and disease progression.
Deeper molecular insight: Provides complementary information beyond mutation detection, particularly valuable when no actionable variants are identified.

Our Technology & Expertise

Advanced Platforms: Leveraging advanced Next-Generation Sequencing (NGS) technologies, in combination with commercially available and proprietary bioinformatics tools, the integrated testing approach ensures accurate, reliable, and comprehensive data.

Expert Scientific Team: Our team consists of specialized molecular biologists and geneticists who translate genomic data into clinically actionable insights, supporting and optimizing personalized therapeutic approaches.

The prime DX® test is performed at the Genekor laboratory, which is CAP-accredited, 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.

High volume and quality of information
Reduced turnaround time
Optimized 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.

Accreditations & Certifications

Genekor ensures a high level of quality, reliability, and security through internationally recognized accreditations and certifications.

Clinical Reliability: CAP-accredited laboratory and accredited according to ISO 15189:2022 (Cert. No. 822)*, ensuring high standards of clinical accuracy.
Data Security: Certified according to ISO/IEC 27001:2022 for Information Security Management, ensuring the protection of sensitive data.
Quality Management: Certified quality management system according to ISO 9001:2015, ensuring continuous improvement of processes and services.
Method Reliability: The prime DX® test is performed using CE-IVD reagents and data analysis and classification software, in compliance with the IVDR Regulation.

*Within the official scope of accreditation.

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