Com.Pl.i.t DX® Breast & Com.Pl.i.t Liquid Breast

Treatment decision-making in recurrent or metastatic ER-positive, HER2-negative breast cancer

Com.Pl.i.t DX® Breast & Com.Pl.i.t Liquid Breast

The Com.Pl.i.t DX® Breast & Com.Pl.i.t Liquid Breast tests are specifically designed for women with ER+ and HER2- breast cancer. These tests are powerful tools for assessing breast cancer status and can be used to determine whether or not a patient should undergo specific targeted treatments.

The Com.Pl.i.t DX® Breast & Com.Pl.i.t DX® Liquid Breast tests are suitable for:

Patients with non-operable tumors and patients with limited or inadequate tissue biopsy material
Patients with multiple metastases.
Patients under treatment or after completion of treatment. In this case, it gives an insight into the possible emergence of new targetable mutations or mutations resistant to the therapy used.

In more detail, the tests are highly recommended for targeted treatment decisions for:

Women with advanced or metastatic ER+/HER2- breast cancer after relapse on prior therapy, in order to decide on treatment with Elacestrant, based on ESR1 gene mutations.
Women with advanced or metastatic ER+/HER2- breast cancer after relapse on prior therapy, in order to decide on treatment with Alpelisib, based on PIK3CA gene mutations.
Women with advanced or metastatic breast cancer relapse on prior therapy, in order to decide on off-label or clinical trial treatments.

The Com.Pl.i.t DX® Breast & Com.Pl.i.t DX® Liquid 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

Immunotherapy biomarkers

MSI
15 loci

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.

Com.Pl.i.t DX® in Additional Tumor Indications

Beyond lung, colon, and breast cancer, Com.Pl.i.t DX® is also available for additional tumor types, including GIST, prostate cancer, cholangiocarcinoma, and melanoma.

The assay enables comprehensive genomic profiling in accordance with international guidelines (e.g. NCCN, ESMO) and can be performed on both tissue and liquid biopsy samples.

Com.Pl.i.t DX® Breast Combo

The parallel use of the two methods enhances the overall accuracy of the molecular profile, contributing to the optimal selection of targeted therapies and the personalization of the treatment approach.
This is particularly important in breast cancer, as for certain biomarkers—such as ESR1—international guidelines recommend testing through liquid biopsy.

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 & Com.Pl.i.t DX® Liquid Breast tests?

Blood in a special STRECK vial supplied by Genekor. Blood in special collection vial that you are going to take from Genekor. (Cell-Free DNA BCT^®(10ml) και Cell-Free RNA BCT^®(10ml)).

How do I get the special vial?

Genekor is responsible for providing and shipping the special vial for the Com.Pl.i.t DX® Liquid 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