Provista Diagnostics has 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 US.
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.
Provista Diagnostics Laboratory Operations and Laboratory Director vice president Dr Sherri Borman said that it is the goal of this trial to confirm the ability of protein-based biomarkers to aid in the radiologic assessment of breast masses.
"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," Dr Borman added.