Clinical Evidence

AR-V7 Nucleus Detect is designed to detect AR-V7 proteins in the nucleus of circulating tumor cells (CTCs). Large clinical studies found that AR-V7+ patients (patients with AR-V7 in the nucleus of CTCs):

• Do not benefit from AR-targeted therapies.
• Experience faster progression and lower median overall survival (compared with patients negative for AR-V7).
• Are substantially more likely to live longer when treated with taxane chemotherapy.^{1, 2}

Study 1: Nuclear AR-V7 presence predicts lack of effectiveness of AR-targeted therapies¹

A study published in JAMA Oncology from Memorial Sloan Kettering Cancer Center demonstrated that mCRPC patients with AR-V7+ CTCs had a 76% reduction of risk of death when treated with chemotherapy. This suggests that patients with detectable blood levels of AR-V7 should consider life-prolonging chemotherapy as an alternative to potentially less effective and more expensive hormonal treatment with AR-targeted therapies.

In the chart below, note that all patients who were nuclear AR-V7+ and treated with an AR-targeted therapy died within 12 months, underscoring lack of efficacy of AR-targeted therapies in this patient population.

AR-V7+ patients treated with AR-targeted therapies had significantly reduced overall survival²*

Study 2: Nuclear-specific localization is required for accurate test results²

A 2016 study published in European Urology analyzed outcomes for patients with mCRPC on AR-targeted therapies and standard chemotherapy. The authors found that patients with nuclear AR-V7 in CTCs were very likely to survive longer on taxane-based chemotherapy, whereas location agnostic AR-V7 expression was less prognostic and not predictive.