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About the test

The HeliDx Expanded Breast Cancer Assay is a versatile solution that analyses all clinically relevant mutations associated with breast, ovarian, and prostate cancers based on scientific and clinical literature.

The assay is performed using formalin-fixed and paraffin-embedded (FFPE) samples.

Results can assist in identifying potential therapeutic options based on cancer specific features.

Indications

The HeliDx Expanded Breast Cancer Assay is designed for those who are likely to have an inherited mutation based on personal or family history of breast cancer or ovarian cancer.

The test is also recommended for those that have Ashkenazi (Eastern European) Jewish ancestry on either side of the family.

What the test evaluates

The HeliDx Expanded Breast Cancer Assay is designed to analyze 15 genes that are associated with breast, ovarian and prostate cancers, including BRCA 1 and 2. This assay enables 100% exonic coverage for BRCA1 and 2 genes, superior uniformity, and high read depth. It detects 5% and below minor-allele frequencies with at least 99% accuracy.

The test also analyses genes associated with the HR pathway (Homologous Recombination). HR is important both for repairing DNA lesions in mitosis and for chromosomal pairing and exchange during meiosis. The fact that failure to repair damaged DNA increases the possibility of developing tumors and other diseases highlight the importance of DNA repair and hence included in this assay.

Advantages of the technology

The HeliDx Expanded Breast Cancer Assay leverages Next Generation sequencing (NGS) technology to examine regions of the tumor genome that tend to get missed by single or hotspot biomarker tests.

The advantages of the HeliDx test are:

  • Complete information of the common oncogenic drivers for breast, ovarian and prostate cancer is obtained and will support clinical decision making more confidently.
  • Analysis of your sample for multiple variants of interest using a single FFPE sample in a single experiment.
  • Detection of single nucleotide changes, inversions, insertions, deletions, and multiple gene fusions in a single run
  • Optimized and accurate results since it includes a positive control design to confirm a true negative vs false negative result.
  • Quick turnaround time of about 10 days.

How the test is performed

With the HeliDx Expanded Breast Cancer Assay, when you visit the doctor for your initial biopsy, the same FFPE tissue sample used by the pathologist to detect cancer can be used for genetic testing.

  • 10 ng of DNA and RNA is then isolated, which can typically be obtained from 2–3 FFPE slides, enabling analysis of samples that may contain partially degraded or limited tumor material.
  • The DNA/RNA library is then prepared and sequenced on a NGS sequencer.
  • Seamless integration of our informatics solutions with our sequencing platforms enables quick and intuitive analysis and reporting once the sequencing is completed.

Request the test

To request the HeliDx Expanded Breast Cancer Assay, or for more information about the test, please feel free to call us at +971 (0)4 375 722 or fill in this form.

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