Study Shows HELIXAFE cfDNA Test Detects Solid Tumors in Healthy Patients

[Source: © Alex Tihonov/Fotolia]

The blood-based cell-free DNA (cfDNA) HELIXAFE test can detect solid tumors even before they develop, according to a study published in the journal Cell Death & Disease by an international group of experts coordinated by Bioscience Genomics, a research entity formed by the collaboration between the University of Rome Tor Vergata and Bioscience Institute. Bioscience Genomics is already selling the test under the name HELIXAFE.

Researchers tested the use of the early prevention program HELIXAFE to screen for genetic alterations in asymptomatic individuals. The goal of this early prevention program is to identify subpopulations of healthy people in which cancer has notyet developedthat canstartto fight the diseaseeven before diagnosis.

This development should lead to wider distribution of the test. “Now we can entertain new partnerships to market HELIXAFE worldwide, “GiuseppeMucci, Bioscience Institute CEO.

Researchers tested HELIXAFE to screen for genetic alterations in healthy, asymptomatic individuals. Early diagnosis is one of the most important goals of cancer research today, as the earlier the disease is diagnosed, the more likely the patient is to be saved. HELIXAFE allows the study of prodomal phase cancer—the asymptomatic stage in which cancer is not yet present but a number of cells have already accumulated genetic alterations—a cancer-linked phenomenon known as genome instability.

Today,several medicines can be used as chemopreventive agents, protecting individuals at high risk of cancer development. As such, the HELIXAFE test could reveal the people who could benefit most from such intervention.

The first step of the studypublished in Cell Death & Diseasewas to demonstrate cfDNA analysis technical feasibilityin healthy individuals.Researchers analyzed blood samples from 114 patients at different times of their course of treatment, during a period ranging from 1 to 10 years. This allowed evaluation of cfDNA sequencing in relation to factors such as its abundance.

In the second step of the study, the validity of thisapproach was confirmed by comparing the results of Bioscience Genomics’analysis of cfDNA samples from oncological patients with the results of the sequencing of DNA from tissue biopsies from the same patients.

Finally, researchers looked for the presence of genetic alterations in healthy volunteers’ cfDNA and in parallel followed their health status up to 1 to 10 years. This made it possible to compare cell-free DNA analysis results in individuals who didn’t develop cancer, people who developed a benign tumor, and people who developed a malignant cancer.

The study demonstrated that the test allows detecgtion of genetic alterations in healthy, asymptomatic people with a 0.08% limit of allelic variant detection. This represents a first step towards new cfDNA applications. Larger prospective studies will be required to confirm the clinical usefulness of this approach.

HELIXAFE is already being commercialized by Bioscience Institute with four different tests: HELIXPAN, for people at low risk for solid cancer; HELIXGYN, for women exposed to hormone therapies or at high risk for breast or ovarian cancer because of BRCA 1 or 2 mutations; HELIXMOKER, for smokers and high pollution-exposed subjects; and HELIXCOLON, which monitors genes related to colon cancer.

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