Natera’s Signatera assay shows treatment reponse prediction capacity

Natera presented data from two studies this week at the 2018 San Antonio Breast Cancer Symposium, demonstrating the ability of its Signatera research-use-only circulating tumor DNA assay to detect molecular residual disease up to two years prior to clinical relapse and to predict treatment response in breast cancer. In a cohort of 82 high-risk early-stage breast cancer patients receiving neoadjuvant therapy, the change of measurable ctDNA from positive to negative during neoadjuvant treatment predicted therapeutic response, while failure to clear ctDNA after neoadjuvant treatment correlated with poor clinical outcomes. ctDNA levels were also associated with tumor burden as determined by imaging. Personalized serial circulating tumor DNA analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 TRIAL. In a cohort of 49 breast cancer patients who received adjuvant therapy, Signatera detected molecular residual disease with a lead time of up to two years prior to clinical or radiological detection. Overall, Signatera detected clinical relapse with a sensitivity of 89 percent and specificity of 100 percent.
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