Provista Diagnostics, Inc., a molecular diagnostics company developing and commercializing proteomic-based diagnostic, prognostic and monitoring tests for cancers affecting women, today announced that the first patient has been enrolled in the company’s 500-patient prospective study of an advanced version of its proteomic breast cancer assay. The assay will measure several protein biomarkers that can be obtained from a small blood sample, with the goal of developing a laboratory test that can assess, in conjunction with standard imaging and the physician’s clinical evaluation, the presence of breast cancer.
This trial will enroll patients, aged 25-75 with suspicious breast masses, at approximately 10 well-known breast cancer centers across the United States. The goal of the study is to determine whether Provista’s biomarkers can distinguish benign lesions from breast cancer in these patients. A small blood sample will be drawn from patients who will be prospectively enrolled in a randomized manner.
“In keeping with Provista’s commitment to the early detection of women’s cancers, we are conducting an unusually rigorous study using Provista’s breast cancer biomarkers,” said David Reese, Ph.D., President and CEO. “We are fortunate to have the support of so many high quality breast cancer centers involved in this important trial.”
According to the American Cancer Society, nearly 233,000 women will be diagnosed with breast cancer in the U.S. in 2014. Approximately 40,000 deaths occur from breast cancer each year. While biomarkers are often used to augment detection in various cancers, definitive markers for breast cancer have remained elusive.
“It is the goal of this trial to confirm the ability of protein-based biomarkers to aid in the radiologic assessment of breast masses,” said Sherri Borman, Ph.D., HCLD, Vice President of Laboratory Operations and Laboratory Director. “The substantial experience of our lab in working with complex clinical laboratory procedures, including development of novel protein based assays, will be invaluable to ensure the highest quality data from this trial.”