Signatera Technology for Personalized Monitoring in Gastrointestinal Cancer Shows Benefits According to a New Study

A new, peer-reviewed case study published in JCO Precision Oncology¹ demonstrates the unique ability of Signatera technology to detect esophageal cancer recurrence almost one year before current standards of care, using a simple blood draw to monitor for traces of circulating tumor DNA (ctDNA).

This report builds upon a fast-growing body of scientific evidence behind the Signatera test across multiple cancer types.

The study follows a 72-year old man with recurrent Stage III esophageal cancer whose recurrence was detected 350 days before radiographic imaging, using Signatera’s personalized and tumor-informed technology. After undergoing multiple CT scans showing no signs of cancer, the patient’s physicians escalated to a PET scan, which revealed a 4 cm nodule in his liver that was later surgically removed. The full study can be found here.

“This case study illustrates the potential advantage of using personalized ctDNA testing as a surveillance tool, especially in the current environment with COVID-19,” commented senior author Eirini Pectasides, M.D., Ph.D., a medical oncologist specializing in gastrointestinal cancer at Dana-Farber Cancer Institute and instructor in medicine at Harvard Medical School.

In the era of COVID-19 and social distancing, where cancer patients are among those with the highest risk of mortality from exposure to the virus, many oncologists are cancelling routine surveillance visits and looking for remote monitoring solutions. In response to the pandemic, Natera has announced a temporary GI Cancer Expanded Access Program that offers compassionate use of the Signatera test for patients with any form of GI cancer through July 31, 2020, including esophageal cancer, which was the focus of the case study. Details of the Expanded Access Program can be found here.

“Patient anxiety around cancer recurrence can be immense,” commented Solomon Moshkevich, General Manager of Natera’s Oncology business. “This case exemplifies the value of early recurrence detection, through blood testing that can be accessed remotely from one’s home.”

Signatera has been validated across multiple cancer types to detect molecular residual disease (MRD) up to 2 years earlier than standard diagnostic tools,^2-5 with virtually no false positives (< 0.3%).³ While a negative test result does not mean someone is definitely cancer-free, it does mean the risk of relapse is significantly reduced. These results, in conjunction with clinical and pathological risk assessment, may help patients avoid treatment with chemotherapy that can weaken the immune system.

References:

1. Einstein DJ, Liang N, Malhotra M, et al. Assessment of molecular remission in oligometastatic esophageal cancer with a personalized circulating tumor DNA assay. JCO PO. 2020;4:239-243.
2. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.
3. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-426.
4. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
5. Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019; 37(18):1547-1557.