Signatera™ for Anal Cancer

Signatera™ redefines anal squamous cell carcinoma surveillance with personalized ctDNA monitoring. This tumor-informed assay identifies patients at the highest risk of treatment failure and detects molecular relapse earlier than standard-of-care imaging, providing the actionable lead time necessary for earlier intervention.

Inform clinical decisions in anal cancer

For ~14% of patients who are the highest risk of treatment failure there is no validated tool to identify who is at risk during or immediately after treatment.¹

Risk stratify patients

100%

1-year OS and PFS were observed in patients who cleared Signatera™ during treatment, with no locoregional failures.²

Catch recurrence sooner

100%

treatment failure when SignateraTM is detectable during surveillance.²

Risk-stratify anal cancer during and after CRT via Signatera™

Identify high-risk patients earlier. Recent data demonstrates 100% locoregional failure-free survival in patients who achieve ctDNA clearance.

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Proven in ASCC: 100% correlation between detectable ctDNA and treatment failure

Patients who converted from Signatera™-negative to Signatera™-positive during surveillance were identified as a high-risk population and underwent expedited clinical evaluation
Signatera™ surveillance is highly predictive: 0% recurrence with sustained cDNA clearance vs. 100% treatment failure when cDNA is detectable

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References

¹James RD et al. Mitomycin or cisplatin chemoradiation ± maintenance chemo for anal SCC (ACT II): phase 3 trial. Lancet Oncol. 2013;14(6):516–24. doi:10.1016/S1470-2045(13)70086.

²Bercz et al., Circulating tumor DNA as an early response indicator in anal squamous cell carcinoma treated with chemoradiation. American Society of Clinical Oncology 2025, Chicago May 30th–June 3rd 2025.