Com.Pl.it DX® - Lung Cancer | The Blueprint of the biology of the tumor

Com.Pl.it DX® Lung Cancer

provides a detailed blueprint of the biology of the tumor by analyzing many genes at the same time, which is used by the treating physician to design the most accurate treatment plan for each patient.

Com.Pl.it DX® Lung is focused on patients with Non-Small-Cell Lung Carcinoma (NSCLC) and it is designed to achieve maximum sensitivity and specificity.

All findings are classified using the most reliable and updated databases and in silico analysis algorithms. The analysis of gene fusions is also included in Com.Pl.it DX®, providing comprehensive and reliable information to patients and physicians.

Next Generation Sequencing (NGS) technology is used for the simultaneous analysis of many genes alterations using the same sample, thus saving valuable material.

The Com.Pl.it DX® Lung Cancer test:

Determines the molecular profile (gene mutations) of the tumor and of interactions between genes in case of multiple mutations.
Designates the on-label drug (if it exists) that targets the mutated gene(s) or the pathway that the gene(s) are involved in.
Identifies mutations associated with resistance to targeted treatment.
Assigns off-label treatments or ongoing clinical trials based on tumor’s molecular profile.
This could be particularly important for patients who have failed conventional therapy.

Table of Genes Analyzed

27 gene alterations

AKT1	ALK	BRAF	CDKN2A	CTNNB1	DDR2
EGFR	ERBB2	FBXW7	FGFR1	FGFR2	FGFR3
HRAS	KEAP	KRAS	MAP2K1	MET	NOTCH1
NRAS	PIK3CA	POLE	PTEN	RET	SMAD4
SMARCA4	STK11	TP53

7 fusion transcripts

ALK

ROS1

RET

NTRK1

NTRK2

NTRK3

MET

Immunotherapy Biomarkers

PD-L1

FAQs

What types of cancer does it cover?

It is designed for patients with lung cancer. It can also be used in other types of solid tumors including those of unknown origin.

In how many days will the results be available?

10 working days.

What specimen type is required for the Com.Pl.i.t DX Lung Assay?

For the Com.Pl.i.t DX Lung Assay we need a paraffin block that contains the tumor tissue. We need one paraffin block or four unstained paraffin sections of 3μm: in positive charged slides (air dried, not baked), placed on top of the slide, without folds and six unstained slides of 10μm.

Are there any special transportation conditions?

The sample should be kept at room temperature (25°C). During the summer period we recommend to have an ice pack in the Kit (The ice pack should not directly touch the sample).

Does the test have any cost coverage from any public/private insurance?

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

How do I make the payment for the test?

The payment can be made by bank transfer or credit/debit card.

How can I send my sample?

Genekor is responsible for all the necessary procedures of the pick-up and return of the patient’s specimen. To arrange your sample pick-up and return, contact us or complete the appropriate Test Order Form.

How will I receive my results?

Your report will electronically be released to your physician via email and/or uploaded to our secure portal and to you via email or mail.

Why should I sign the consent form?

Genekor Medical S.A. is certified with ELOT EN ISO9001:2008 and ELOT EN ISO15189:2012, which require the written consent of each patient for the use of his/her genetic material for testing.

Genekor’s Validation Studies for Com.Pl.it DX® Lung

“The use of sensitive mutation detection techniques in a large study population of Greek NSCLC patients in routine diagnostic practice revealed an overall EGFR mutation frequency of 15.83%. Of note, there was a 99.8% concordance between the HRM method and Sanger sequencing. NGS was found to be the most sensitive method.”

_{Papadopoulou E, Tsoulos N, Tsirigoti A, Apessos A, Agiannitopoulos K, Metaxa-Mariatou V, Zarogoulidis K, Zarogoulidis P, Kasarakis D, Kakolyris S, Dahabreh J, Vlastos F, Zoublios C, Rapti A, Papageorgiou NG, Veldekis D, Gaga M, Aravantinos G, Karavasilis V, Karagiannidis N, Nasioulas G. Determination of EGFR and KRAS mutational status in Greek non-small-cell lung cancer patients. Oncol Lett. 2015 Oct;10(4):2176-2184.}

“In total, alterations in a cancer-driver gene were identified in 77.6% of the tumors tested. Among the NSCLC patients, 23% presented a mutation in a gene associated with approved or emerging targeted therapy. Thus, the targeted NGS panel used in this study is a reliable approach for tumor molecular profiling and can be applied in personalized treatment decision making for NSCLC patients.”

_{Tsoulos N, Papadopoulou E, Metaxa-Mariatou V, Tsaousis G, Efstathiadou C, Tounta G, Scapeti A, Bourkoula E, Zarogoulidis P, Pentheroudakis G, Kakolyris S, Boukovinas I, Papakotoulas P, Athanasiadis E, Floros T, Koumarianou A, Barbounis V, Dinischiotu A, Nasioulas G. Tumor molecular profiling of NSCLC patients using next generation sequencing. Oncol Rep. 2017 Dec;38(6):3419-3429.}

Panel Analytics

_{The gene panel used in this study contains all important genes with actionable mutations related to NSCLC. Therefore, it is deemed optimal for clinical use in this tumor type. Additionally, it exhibits high rates (100%) of sensitivity and specificity at a low mutation frequency of 3%.}