Com.Pl.i.t DX® GIST

Com.Pl.i.t DX® GIST (FFPE/Liquid)

Com.Pl.i.t DX® multi-gene tests provide valuable insights that support the selection of optimal targeted therapies for patients.

Through the simultaneous analysis of multiple genes, they deliver a detailed molecular profile of tumor biology, enabling treating physicians to personalize treatment strategies for each patient.

Com.Pl.i.t DX® tests are essential in precision oncology by:

Com.Pl.i.t DX® GIST is designed to support the treating physician in selecting the optimal treatment for patients with Gastrointestinal Stromal Tumor (GIST), based on tumor biology.

Technology & Testing Approach

Tissue biopsy (FFPE): Provides comprehensive genomic profiling from tumor tissue.
Liquid biopsy (ctDNA): Uses a blood sample to analyze circulating tumor DNA, enabling highly sensitive detection of genomic alterations, including those present at low allele frequencies.
Combined approach (Tissue + Liquid): The parallel use of both methods increases diagnostic sensitivity, improves detection of actionable alterations, and supports faster treatment decisions.

Sample Types & Turnaround Time

Tissue biopsy (FFPE): Sample: Formalin Paraffin-Embedded Tissue (FFPET)

Liquid biopsy (ctDNA): Sample: 10ml of whole peripheral blood in one Cell-Free DNA
BCT STRECK vial

Result time: 10 working days

Com.Pl.i.t DX® GIST – Molecular Testing with NGS

17 DNA genes

ARID1A*	ATRX*	BRAF*	ERBB2*	KIT	KRAS*	NF1*	PDGFRA*	PIK3CA*	PTEN*
RB1*	SDHA*	SDHAF2*	SDHB*	SDHC*	SDHD*	TP53*

*CNV (amplification/deletion) analysis is included for these genes

9 Fusions

ALK	FGFR1	FGFR2	FGFR3	NTRK1	NTRK2	NTRK3	RET	ROS1

				MSI

Biomarkers with Approved Treatment

KIT
PDGFRA

Includes tissue-agnostic biomarkers:

BRAF
ERBB2 (HER2) amplification
RET fusions
NTRK1/2/3 fusions
MSI

Additional clinically relevant biomarkers:

SDH deficiency (SDHA, SDHB, SDHC, SDCD)

Combined Tissue & Liquid Testing

Simultaneous molecular testing of tissue and liquid biopsies in patients with Gastrointestinal stromal tumor (GIST) is the optimal diagnostic approach.

Each method has a certain rate of false negatives; therefore, combining them increases diagnostic sensitivity and leads to the detection of more actionable molecular alterations.

In addition, the parallel use of the two methods can:

• Increase the possibility of identifying actionable alterations
• Allow for faster initiation of appropriate treatment

Accreditations & Certifications

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

Clinical Reliability: Accredited Laboratory according to ISO 15189:2022 (Accreditation No. 822)* and accredited by the CAP (College of American Pathologists)
Data Security: Certified according to ISO/IEC 27001:2022 for Information Security Management
Quality Management: Certified Quality Management System according to ISO 9001:2015
Method Reliability: The Com.Pl.i.t 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.

Frequently Asked Questions

What is the sample type required for the Com.Pl.i.t DX® analysis?

For the Com.Pli.t.DX® analysis, either a formalin-fixed paraffin-embedded (FFPE) tumor tissue block or, alternatively, unstained FFPE tissue sections mounted on glass slides (air-dried, not oven-dried) is required. Specifically, 4 sections of 3 μm thickness and 6 sections of 10 μm thickness are needed.

For liquid biopsy analysis (ctDNA), the sample must consist of 10 mL of peripheral whole blood collected in a Cell-Free DNA BCT STRECK tube.

How do I get the special vial?

Genekor is responsible for supplying and shipping the special vial for the Com.Pl.i.t DX® Liquid test. Please contact us.

Are there any special instructions for collecting a blood sample?

Yes, click here for more information on the specific instructions for collecting a blood sample.

How do I send my sample and receive my results?

Genekor is responsible for all necessary procedures for the receipt and return of your sample.

Your results will be shared with your doctor via a secure network and to you via e-mail with a secure unique code provided by customer service.

In how many days will I receive my results?

Results will be available within 10 business days of the day after receiving your sample.

Is the test covered by any public / private insurance?

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

How can I make the payment for the test?

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

Why do I have to sign the consent form?

Genekor Medical SA is certified according to ISO 9001:2015 (Cert. No. 041150049) and according to ELOT ISO/IEC 27001:2013 (Cert. No. 048190009) by TUV NORD HELLAS, which require the written consent of each patient for the use of their genetic material for testing.

It is also necessary in accordance with data protection regulations.

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.

CONSENT FORM