Natera reported two peer-reviewed studies on its Signatera tumor-informed circulating tumor DNA assay in anal squamous cell carcinoma $(ASCC)$ and locally advanced rectal cancer (LARC), published in Nature Communications and Cancers. In the ASCC study of 84 patients, those who were Signatera-negative at baseline or cleared ctDNA during chemoradiotherapy had 100% 1-year overall survival, while patients who remained ctDNA-positive after chemoradiotherapy had 63% 1-year overall survival. The study also reported that in recurrent cases, Signatera positivity preceded clinical and/or radiographic recurrence in 100% of cases. In the LARC study of 220 patients treated with neoadjuvant therapy followed by non-operative management or surgery, Signatera-positive non-operative management patients had a 4.62x higher risk of regrowth requiring surgery (p=0.003). The LARC analysis also reported relapse rates of 11.5% for post-operative Signatera-negative patients versus 88% for Signatera-positive patients (p<0.0001).
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