Com.Pl.i.t DX® Breast

The Com.Pl.i.t DX® Breast tests are powerful tools for assessing breast cancer status and can be used to determine whether a patient should undergo specific targeted treatments.

The Com.Pl.i.t DX® Breast tests:

Determine the molecular profile of the tumor, including gene mutations and copy number variations.
Identify the on-label drug that targets the mutated gene(s) or the pathway in which these gene(s) are involved.
Detect mutations associated with resistance to targeted therapies.
Recommend off-label therapeutic options and/or indicate therapies currently under evaluation in clinical trials.

23 Gene Alterations

AKT1	BRCA1*	BRCA2*	CDH1	CDK4*	CDK6*	CCND1*	EGFR*	ERBB2*(HER2)	ERBB3
ESR1	FBXW7	FGFR1	FGFR2*	FGFR3*	GATA3	KRAS*	NF1	PALB2*	PIK3CA*
PTEN*	RB1*	TP53*

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

7 Fusions

FGFR1	FGFR2	FGFR3	NTRK1	NTRK2	NTRK3	RET

MSI

It provides a complete molecular profile including biomarkers with approved treatments as well as emerging biomarkers according to international guidelines.

Biomarkers with Approved Treatment

HR+, HER2– Breast Cancer:

• AKT1 • ESR1
• PIK3CA • PTEN

All breast cancer subtypes:

• BRCA1/2 • PALB2 • NTRK1/2/3 fusions
• RET fusions • MSI

Liquid Biopsy Utility

• Patients with limited or insufficient tissue
• Disease monitoring during or after treatment
• Detection of treatment resistance

Combined Testing

The combination of tissue and liquid biopsy increases diagnostic sensitivity and supports optimally targeted therapy selection.

Combined Tissue & Liquid Testing

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

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

• Increase the likelihood of identifying clinically actionable alterations
• Allow for the 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 types of cancer do the tests cover?

They cover recurrent or metastatic ER+/HER2- breast cancer.

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

For the Com.Pli.t.DX® Breast 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 providing and shipping the special vial for the Com.Pl.i.t DX® Breast 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 in 10 working days from the day after your sample is received.

Are the tests covered by any public or private insurance?

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

How can I make the payment for the tests?

The Customer Service Department will provide you with a unique e-banking payment code, or payment can be made by card or bank transfer.

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 tests?

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