Com.Pl.i.t DX® Colon

Com.Pl.i.t DX® multi-gene tests provide valuable information that can be used to select the optimal targeted therapy for patients. By simultaneously analyzing multiple genes, they provide a detailed fingerprint of tumor biology, enabling treating physicians to personalize the patient's treatment plan.

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

Determining the tumor’s molecular profile, including gene alterations, rearrangements, and copy number alterations in both late-stage and early-stage tumors, providing a more comprehensive assessment.

Identifying approved targeted therapies relevant to the detected molecular alterations or dysregulated pathways.

Detecting molecular alterations associated with resistance to targeted treatments.

Supporting therapeutic decision‑making by highlighting potential off‑label treatment options and identifying relevant ongoing clinical trials.

How the Com.Pl.i.t DX® colon test helps in finding the right treatment

It determines the molecular profile (gene mutations) of the tumor and the interactions between genes in cases of multiple mutations
Identifies on-label drugs, which target either the mutated genes or the pathways in which they are involved
It identifies mutations associated with resistance to targeted therapies
Recommends off-label therapies or treatments in clinical trials based on the molecular profile of the tumor. This may be particularly important for patients where standard treatment has failed

Com.Pl.i.t DX® Colon (FFPE)

Table of analysed genes

77 DNA genes
ABL1	AKT1	ALK	APC	ARAF	ATM	BRAF	BRCA2	CCNE1*	CDH1
CDKN2A*	CSF1R	CTNNB1	DDR2	DICER1	EGFR*	EIF1AX	ERBB2*	ERBB3	ERBB4
EZH2	FBXW7	FGFR1*	FGFR2*	FGFR3	FLT3	FOXL2	GNA11	GNAQ	GNAS
HGF	HNF1A	HRAS	IDH1	IDH2	JAK2	JAK3	KDR	KEAP1	KIT
KRAS	LAG3	MAP2K1	MDM2	MET*	MLH1*	MPL	MTAP*	MYC	NOTCH1
NPM1	NRAS	NTRK1	NTRK2	NTRK3	PDGFRA	PIK3CA	PIK3R1	POLD1	POLE
PTEN*	PTPN11	RAC1	RAF1	RB1	RET	ROS1	SMAD4	SMARCA4*	SMARCB1
SMO	SPOP	STK11	SRC	TERT	TP53	VHL

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

19 Gene fusions

ALK	BRAF	EGFR	ERG	FGFR1	FGFR2	FGFR3	MET	NRG1	NTRK1
NTRK2	NTRK3	PBX1	PPARG	PRKACA	RAF1	RET	ROS1	TFE3

MSI

IHC biomarkers can be requested as add-on

Immunohistochemistry

HER2

Approved targeted therapies include:

KRAS/NRAS wild type: identifies patients eligible for anti-EGFR treatment

KRAS G12C, BRAF V600E, HER2 amplification: guide targeted therapy selection

NTRK1/2/3 & RET fusions: guide targeted therapy selection

MSI, POLE, POLD1: predict response to immune checkpoint inhibitors

Com.Pl.i.t DX® (Liquid & Combo)

Com.Pl.i.t DX® Liquid analysis provides a comprehensive molecular profile through minimally invasive sampling.

Com.Pl.i.t DX® Colon (Liquid)

Gene Table

64 Genes with SNV/Indels Analyzed
AKT1	ALK	APC	ARAF	ATM*	BRAF	BRCA2*	CDH1	CDKN2A*	CSF1R
CTNNB1	DDR2	EGFR*	ERBB2*	ERBB3	ERBB4	EZH2	FBXW7	FGFR1	FGFR2*
FGFR3*	FLT3	FOXL2	GNA11	GNAQ	GNAS	HNF1A	HRAS	IDH1	IDH2
JAK2	KDR	KEAP1	KIT	KRAS*	MAP2K1	MDM2	MET*	MLH1*	MYC
NOTCH1	NPM1	NRAS	NTRK1	NTRK2	NTRK3	PDGFRA	PIK3CA*	POLE	PTEN*
PTPN11	RAF1	RB1*	RET	ROS1	SMAD4	SMARCA4	SMARCB1	SMO	SPOP
STK11	TERT	TP53*	VHL*

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

9 Fusions

ALK	FGFR1	FGFR2	FGFR3	NTRK1	NTRK2	NTRK3	RET	ROS1

MSI

Molecular Profiling in Early Stage Colon Cancer

According to the updated NCCN 2026 guidelines, molecular profiling should be performed in all stage II and III colorectal cancers.

Recommended testing includes MMR/MSI, POLE/POLD1 and PI3K pathway alterations (PIK3CA, PIK3R1, PTEN) which can inform personalized adjuvant treatment decisions.

Combined Tissue & Liquid Biopsy Testing

Simultaneous molecular testing of tissue biopsy and liquid biopsy in patients with colorectal cancer represents the optimal diagnostic approach.

Each method presents a certain rate of false-negative results; therefore, their combination increases diagnostic sensitivity and leads to the detection of a greater number of clinically actionable molecular alterations.

In addition, the parallel use of both methods may:

• Increase the likelihood of identifying clinically actionable alterations
• Enable the faster initiation of the 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 types of cancer does it cover?: It is designed for patients with colorectal cancer.
In how many days will the results be available?: Com.Pl.i.t DX® Colon results will be available in 10 business days from the day after sample receipt.
What kind of sample is required for Com.Pl.i.t DX® Colon?: For the analysis of Com.Pl.i.t.DX® colon we need the paraffin cube from the tumor or alternatively uncolored paraffin sections coated on slides (air-dried, not oven-dried). More specifically, we need 4 sections of 3μm and 6 sections of 10μm.
Are there any special transportation conditions?: The sample should be kept at room temperature (25 °C). During the summer season we recommend having an ice pack in the kit (The ice pack should not directly touch the samples and the documents)
Is the test covered by public/private insurance?: For information about the cost of the test you should contact your personal insurance or our company.
How can I make the payment for the test?: The Customer Service Department will provide you with a unique e-banking payment code, or payment can be made by card or bank transfer.
How can I send my sample?: Genekor is responsible for all necessary procedures for the receipt and return of your sample. To arrange sample collection and return, please contact us.
How will I get my results?: 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.
Why do I have to 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 data protection regulations.
You can view our certifications here.

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