Genomic Health’s Oncotype DX has met its primary endpoint in a clinical validation study investigating patients with ductal carcinoma in situ (DCIS), a type of breast cancer.

Oncotype DX is the first multigene expression test to predict the risk of recurrence in patients with early-stage breast cancer.

The E5194 study demonstrated that patients with a low DCIS score had a 12% less likelihood of a the cancer recurring locally, and an even lower 5% likelihood of developing a new invasive breast cancer.

The study also reported that patients with high DCIS score had a 27% likelihood of local recurrence, of which around half was expected to develop a new invasive breast cancer.

Principal study investigator Lawrence Solin said that the multigene test can be used to differentiate lower risk DCIS from higher risk DCIS, for which adjuvant treatment including radiation should be considered in addition to surgery.

"The DCIS Score will help physicians understand the underlying biology of DCIS for an individual patient and accurately gauge the risk for that person, enabling the patient and physician to decide on the appropriate course of treatment based on a more complete understanding of the risk involved," Solin added.

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The DCIS Score also showed relation with local recurrence across subgroups regardless of lesion size, grade, surgical margins, or menopausal status.