Positive results from trial of Videssa Breast diagnostic system for early stage breast cancer- Provista Diagnostics

Provista Diagnostics has announced positive results from Provista 002, a large, multi-center trial for its diagnostic test, Videssa Breast, for detecting breast cancer. Representing over 500 patients, results from samples analyzed in the second cohort of the Provista 002 trial replicate findings from the first cohort, providing a strong clinical validation for the diagnostic assay.

The prospectively collected, randomized, blinded, multi-center study, Provista 002, enrolled a total of 1,005 patients, split across two cohorts. Prior results from the first 500 patients demonstrated highly accurate detection of early breast cancers independent of breast density status. These results showed that, when compared between the two cohorts, Videssa Breast provided consistent results, regardless of variations in sample source, including the age, race, geography or clinical history of the patient or clinical trial site.

Comment: Videssa Breast is intended for use in women between the ages of 25-75 years, who have questionable mammographic finding and/or dense breast tissue. In combination with clinical and radiologic evaluations, Videssa Breast is designed to accurately detect the presence or absence of invasive breast cancer/ductal carcinoma in situ and reduce unnecessary follow-up procedures such as further imaging and biopsies.