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Provista completes enrollment in biomarker assay’s second cohort to detect breast cancer

Molecular diagnostics firm Provista Diagnostics has completed the enrollment of patients in the second cohort of a prospective study of its protein-based biomarker blood test to detect breast cancer.

The company has enrolled 509 women in the second cohort of the 002 study, which will be monitored for six and 12 months for clinical outcomes.

Provista enrolled around 1,020 patients in both cohorts, including one and two, of the 002 study. They were enrolled at 12 breast cancer centers across the US.

Provista CEO and president Dr David Reese said: "This is a ‘first of its kind’ study of randomized, prospective trials that demonstrate the utility of well-established proteomic biomarker panels in the early detection of breast cancer."

The trial is a multi-center and randomized study, which seeks to validate blood-based biomarker panel assay in conjunction with imaging to differentiate benign breast lesions from invasive cancers.

According to the firm, the trial is a follow-up to its 001 trial that enrolled 351 women under the age of 50 with suspicious lesions, increasing collective prospective clinical trial enrollment to 1,371 patients up to now.

The study will determine whether a collection of biomarkers identified by the firm’s test can differentiate malignant from benign tumors.