Molecular diagnostic firm MetaStat has revealed preliminary results from a study of MetaSite Breast test in patients with ER-positive, HER2-negative early stage invasive breast cancer.
According to the firm, the study reached its prospectively defined primary endpoint.
The Kaiser Cohort MetaSite Breast clinical trial is a case-controlled nested cohort of 3,760 patients with invasive ductal carcinoma of the breast diagnosed between 1980 and 2000 followed through 2010 from the Kaiser Permanente Northwest health care system.
Case patients included women diagnosed with invasive breast cancer who subsequent developed distant metastasis.
The study showed that MetaSite Brease Score is significantly and directly associated with increased risk of distant metastasis in ER-positive HER2-negative invasive breast cancer for both high versus low MetaSite scores, as well as between intermediate and low MetaSite scores.
The MetaSite Breast Score estimated risk of distant metastasis in ER-positive, HER2-negative early stage invasive breast cancer independent of traditional clinical factors.
MetaStat president and CEO Douglas Hamilton said: "We are encouraged by these results including the separation of the low and intermediate risk groups in addition to the low and high risk groups.
"We look forward to conducting additional clinical validation studies demonstrating the prognostic and chemo-predictive power of the MetaSite Breast test as we prepare for commercialization in 2016."
MetaStat, which also produces MenaCalc assay, develops and markets tissue-based diagnostic tests for prediction of cancer metastasis.