GeneNews (TSX:GEN) has launched BreastSentry, a new risk stratification test for breast cancer, via its Virginia-based clinical reference lab, Innovative Diagnostics Laboratory (IDL).
BreastSentry incorporates a blood-based biomarker test with a sophisticated algorithm to determine a woman’s five-year and lifetime risk for developing breast cancer.
BreastSentry measures the fasting plasma levels of two biomarkers in the blood: proneurotensin (pro-NT) and proenkephalin (pro-ENK), which are highly predictive of a woman’s risk for developing breast cancer. Various longitudinal clinical studies have shown that elevated levels of pro-NT and decreased levels of pro-ENK are strong, independent risk factors for the development of breast cancer.
In addition, BreastSentry measures seven key risk factors, based on the Gail Model, for developing breast cancer to provide an additional level of personal data into the risk stratification algorithm to create a personalized score.
The Gail Model is a statistical breast cancer risk assessment algorithm designed by scientists at the NCI and the National Surgical Adjuvant Breast and Bowel Project to estimate a woman's risk of developing invasive breast cancer.
Elevated risk scores can help physicians determine if further screening with 3D Tomography, Screening Breast Ultrasound and/or MRI are necessary.
“We are excited to make this test available to women throughout the U.S. who are concerned with their risk for developing breast cancer, especially those 50% of U.S. women with dense breast tissue, who cannot rely on mammography alone to determine if they currently have the disease,” James Howard-Tripp, chairman and CEO of GeneNews, said in a statement.
Approximately two-thirds of pre-menopausal and one-quarter of post-menopausal women have dense breast tissue, which makes it challenging to detect breast cancer by mammography alone. High breast density, as seen on a mammogram, is linked to an increased risk of breast cancer.
To help physicians determine what comes next following either an elevated or normal BreastSentry test score, GeneNews and IDL have also developed a BreastSentry Patient Advocacy Protocol.
“This is a significant breakthrough for women with dense breasts,” said Dr. Belinda Barclay-White, founder and medical director of Arizona Breastnet, a full service diagnostic breast center.
"Any additional information that can be added to a patient profile to determine ongoing risk for developing breast cancer is very much needed to help physicians, radiologists and patients determine what the next course of action should be," she added.