Com.pl.i.t DX® Lung

Com.Pl.it DX® Lung

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.

Choosing an Appropriate Treatment Plan for Patients with Non-Small Cell Lung Cancer (NSCLC)

The ComPlit DX ® Lung multigene test is designed specifically for patients with Non-Small Cell Lung Cancer (NSCLC), and it can be used in other types of solid tumors, including those of unknown primary tumor.

The Com.Pl.it DX® Lung Cancer Test:

determines the molecular profile (gene mutations) of the tumor and the interactions between genes in cases of multiple mutations.
identifies on-label drugs that target either the mutated gene(s) or the pathways in which they are involved.
identifies mutations associated with resistance to targeted therapies.
Recommends treatments that are approved for the specific mutation, but for a different type of tumor (off-label) and/or indicates treatments that are currently in clinical trials.

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® Lung (FFPE)

Com.Pl.i.t DX® Lung is designed to help the treating physician select the optimal treatment for patients with Non-Small Cell Lung Cancer (NSCLC) based on tumor biology.

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	LAG-3	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 RNA Genes

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
PD-L1	HER2	c-MET

Com.Pl.i.t DX® Lung provides a complete molecular profile for NSCLC patients with
prognostic and predictive value, following NCCN guidelines for targeted therapies

Biomarkers with approved therapy

EGFR, BRAF V600E, KRAS G12C, ERBB2 (DNA Sequencing)
ALK, NRG1, NTRK1/2/3, ROS1, RET (RNA Sequencing)
MET exon 14 skipping alteration (DNA & RNA Sequencing)
PD-L1, HER2, c-MET overexpression (IHC)

Emerging biomarkers

MET amplification (DNA Sequencing)
FGFR1/3 alterations (DNA & RNA Sequencing)
MTAP loss

Biomarkers of immunotherapy resistance

STK11 inactivating mutation
KEAP1 inactivating mutation

Com.Pl.i.t DX® (Liquid & Combo)

Com.Pl.i.t DX® Liquid analysis provides a minimally invasive approach for selecting optimal targeted therapies for patients. By simultaneously analyzing multiple genes, it generates a comprehensive molecular profile of the tumor’s biology. In addition, liquid biopsy analysis is ideal for detecting resistance alterations associated with targeted therapies. This test is particularly valuable when tissue samples are unavailable or insufficient, and it can also be used alongside tissue analysis to enhance clinically relevant information.

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	FOXL2	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	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

Combined Tissue & Liquid Testing

Simultaneous molecular testing of tissue and liquid biopsies in patients with NSCLC
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

Frequently Asked Questions

What types of cancer does it cover?: It is designed for patients with Non-Small Cell Lung Cancer (NSCLC). It can also be used in other types of solid tumors, including those of unknown primary tumor.
In how many days will the results be available?: Com.Pl.i.t DX® Lung results will be available in 10 business days.
What type of sample is required for Com.Pl.i.t DX® Lung?: For Com.Pl.i.t.DX® Lung analysis we need the paraffin cube from the tumor or alternatively uncolored paraffin sections coated on slides (air-dried, not oven-dried). 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 touch the samples directly).
Is the test covered by public/private insurance?: For information regarding insurance cost coverage, please contact your insurance provider or our customer service department.
How can I make the payment?: Payment can be made via bank transfer or credit/debit card.
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 through a secure network and sent to you via email using a unique secure access code provided by our customer service department.
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.