Com.Pl.it DX® Liquid Breast

Multigene Liquid Biopsy Test for postmenopausal women with recurrent or metastatic breast cancer ER+, HER2-

Com.Pl.i.t DX® Liquid Breast

The Com.pl.i.t DX® Liquid Breast test is specifically designed for postmenopausal women with ER+ and HER2- breast cancer. This test is a powerful tool for assessing breast cancer status and can be used to decide whether or not a patient should undergo specific targeted treatments.

The Com.pl.i.t DX® Liquid Breast Test is 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 test is highly recommended for targeted treatment decisions for:

Postmenopausal 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.
Postmenopausal 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.
Postmenopausal women with advanced or metastatic breast cancer relapse on prior therapy, in order to decide on off-label or clinical trial treatments.

The test Com.pl.i.t DX Liquid Breast:

Determines the molecular profile of the tumor such as gene mutations and Copy Number Variations for inoperable tumors.
Designates the on-label drug that targets the mutated gene(s) or the pathway that the gene(s) are involved.
Identifies the mutations associated with resistance to targeted treatment.
Recommends off-label therapies and/or indicates therapies that are currently in clinical trials.

10 Gene Alterations

Hotspot genes (appr. 152 hotspots:)	AKT1	EGFR	ERBB2	ERBB3	ESR1	FBXW7	KRAS	PIK3CA	SF3B1	TPS3

Copy Number Variation- CNV

Copy number genes (CNVs):	CCND1	ERBB2	FGFR1
Full length genes	TP53

In the gene panel above, we detect mutations in the ESR1 gene (incidence 48% as a mechanism of resistance to hormone therapy, based on the Emerald study).

We also detect PIK3CA mutations with the approved treatment Alpelisib, as well as other genes for which there are experimental or off-label treatments.

BIOMARKERS ASSOCIATED WITH FDA-APPROVED THERAPIES

Frequently Asked Questions

What types of cancer does it cover?

Covers recurrent or metastatic breast cancer ER+/HER2-

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

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.

Is the test covered by any public / private insurance?

For information about the cost coverage 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.

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 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