dtectDx™ Breast Assay Plus Standard of Care Improves Breast Cancer Detection in Women Younger than 50

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(ChemotherapyAdvisor) – Use of the dtectDx™ Breast assay, combined with standard of care, improves breast cancer detection in women younger than 50 years of age in the practice setting, Meredith C. Henderson, PhD, of Provista Diagnostics, Scottsdale, AZ, reported during the 2013 Breast Cancer Symposium held in San Francisco, CA.

These results confirm those of a previous clinical study of the assay, which found that the proprietary algorithm performed best in that age group.

The dtectDx Breast test analyzes serum concentrations of five protein biomarkers—interleukin-8 (IL-8), IL-12, vascular endothelial growth factor, carcinoembryonic antigen, and hepatocyte growth factor—via enzyme-linked immunosorbent assay to detect breast cancer. These data, when combined with select patient characteristics and the algorithm, “results in a test value that is characterized as normal or elevated,” she said.

The study reviewed breast test reports for women younger than 50 years from a 3-year period. Prescribing physicians who prescribed the dtectDx Breast test were interviewed regarding follow-up care and outcome measures, which were largely imaging studies.

Of 908 patients, eight samples were rejected based on serum quality. Of the 900 included, 121 (12.7%) patients had results that were reported as elevated; four were confirmed as cases of breast cancer.

Two of the four patients initially showed no screening evidence of cancer. However, after receipt of the dtextDx Breast test results and further evaluation, they were diagnosed with breast cancer, Dr. Henderson noted.

The false-positive rate was found to be higher when used in the practice setting (12.7%) than that reported in the clinical study (6.8%).

“Since two of the invasive cancer cases were originally not detected via standard screening procedures, the assay has demonstrated important clinical utility when used in conjunction with mammography/standard of care,” Dr. Henderson concluded.

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