Breast and ovarian cancer interception
HELIXGYN
HELIXGYN is a dedicated monitoring tool for evaluating genomic alterations associated with increased breast and ovarian cancer risk in women with specific hereditary or hormonal risk factors.
HELIXGYN is specifically designed for women who carry pathogenic variants in the BRCA1 or BRCA2 genes, placing them at a significantly elevated lifetime risk of developing breast or ovarian cancer. This test provides a targeted surveillance strategy by monitoring somatic alterations whose early detection may support more informed preventive or clinical decisions.
HELIXGYN is also indicated for women exposed to additional hormonal risk factors—such as hormone replacement therapy (HRT), long-term use of hormonal contraceptives, or ovarian stimulation—conditions known to influence genomic stability. By integrating molecular analysis with individual risk history, HELIXGYN offers a precise, evidence-based approach to early interception and personalized prevention.
Indications
The HELIXGYN prevention program is recommended for all women:
- who are familiar with the mutation in the BRCA 1 and BRCA 2 genes, and therefore are at greater risk of developing breast or ovarian cancer;
- who are taking (or have taken) hormone replacement therapy (HRT) or hormonal contraceptives;
- who have undergone ovarian stimulation.
What the test evaluates
HELIXGYN evaluates the genetic stability and therefore the safety conditions in which hormonal therapies are carried out by monitoring the frequencies of somatic mutations in the genome, with special attention for the alterations more sensitive to that type of stimulation. Before starting any hormonal therapy, it would therefore be advisable to start a monitoring program, with annual repetition, of the mutational profile.
| 11 Genes | 157 HOTSPOTS |
|---|---|
|
AKT1 FBXW7
EGFR KRAS
ERBB2 PIK3CA
ERBB3 SF3B1
ESR1 TP53
|
PIK3CA: E545K and H1047R AKT1: E17K ESR1: Mutations associated with anti estrogen resistance ERBB3: Mutations associated with loss of function ERBB2: Mutations associated with sensitivity to anti-ERBB2 therapies |
An innovative model
HELIXGYN represents a modern, evidence-based approach to breast and ovarian cancer prevention, focusing on the objective evaluation of somatic mutations rather than relying solely on hereditary or family-based risk assessments. By applying liquid biopsy and advanced Next Generation Sequencing (NGS) technologies, the test detects and quantifies acquired mutations that may signal early genomic alterations associated with hormone-sensitive gynecologic tumors.
Its real strength lies in the possibility of repeating the analysis annually, allowing continuous monitoring of mutation dynamics over time. By comparing data year after year, HELIXGYN offers a dynamic assessment of genomic stability in women at increased gynecological risk, facilitating the early interception of emerging alterations and supporting more accurate and personalized preventive strategies.
How the test is performed
Bioscience Institute offers pre-test advice and provides all useful information about the prevention program and the execution of the HELIXGYN test.
The test involves a simple blood sample that can be performed at one of our reference centers or through your doctor.
The Bioscience Institute laboratories extract the DNA present in the sample and sequence it using the advanced Next Generation Sequencing (NGS) techniques. The subsequent bioinformatics analysis allows the determination of the presence of any mutations in the genes under examination.
Test results are available in approximately 30 days.