New Breast Cancer Test Identifies Cancer Recurrence Risk

Unlike other assays used to determine the likelihood of recurrence, the profile uses a combination of pathologic risk factors and molecular markers to categorize patients as either high or low risk.

The Insight Dx Breast Cancer profile launched by Clarient (Aliso Viejo, CA, USA) combines three traditional pathology-staging risk factors with seven key molecular markers. Staging factors are tumor size, tumor grade, and lymph node status. Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC. The information is then combined with a proprietary algorithm to produce a risk score that assists pathologists and oncologists in clinical decision-making. "With the launch of the Clarient Insight Dx Breast Cancer Profile, we move one step closer to fulfilling our vision of transforming breast cancer from a deadly disease to a chronic disorder," stated Ron Andrews, CEO of Clarient.

An independent study was conducted by Clarient using a set of breast cancer patients from the Royal Perth Hospital in Western Australia to clinically validate the Insight Dx Breast Cancer Profile. The algorithm demonstrated an accurate, actionable risk recurrence score. In the study, high- and low-risk patients were identified using the Clarient Insight Dx Breast Cancer Profile. The low-risk group had only a 3% recurrence rate 10 years after surgery. This is equivalent to a negative predictive value of about 97%. The corresponding positive predictive value was 39%.

Clarient combines technologies with world-class expertise to assess and characterize cancer. Principal customers include pathologists, oncologists, hospitals, and biopharmaceutical companies.

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