Landmark CIRCULATE-Japan Study Shows Natera’s Signatera™ MRD Test Predicts Benefits of Chemotherapy in Colorectal Cancer

Analysis of over 1,000 patients, with an average follow-up of 12 months, demonstrates the clinical utility of Signatera to inform post-surgical treatment decisions

AUSTIN, TX, January 22, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, today announced recently presented new data on the clinical utility of Signatera, its personalized, tumor-informed molecular residual disease (MRD) test, during from the 2022 American Society of Clinical Oncology Symposium on Gastrointestinal Cancers (ASCO GI). The oral presentation included an updated analysis of the landmark CIRCULATE-Japan trial analyzing a cohort of colorectal cancer (CRC) patients.

More … than 3,000 CRCs patients are now enrolled in CIRCULATE-Japan, the largest prospective, multicenter, MRD-guided trial in CRC, using Signatera to monitor MRD status in patients with stage I-IV CRC for up to 96 weeks postoperatively. The latest analysis of more than 1,000 patients from the GALAXY observational arm of the study highlighted three new findings that were presented at the conference:

  • Signatera positivity is predictive of treatment benefit: patients who were positive for MRM at 4 weeks post-operative benefited significantly from adjuvant chemotherapy (ACT), at all stages of the disease.

  • Signatera-negative patients did not benefit from ACT: patients with high-risk stage II and stage III disease who were MRM-negative at 4 weeks post-operative did not benefit significant of the ACT (p-value of 0.63).

  • Signatera dynamics during ACT are predictive of treatment benefit: 68% of ACT-treated patients cumulatively cleared their cDNA at week 24 and had significantly better outcomes compared to those who remained positive for ACT. cDNA, with a relative risk of 15.8.

Additionally, the post-surgical single-time point sensitivity of Signatera in stage II and III CRC was 67.6%. This sensitivity analysis included more than 5 times more cancer recurrences than previously reported in Reinert, et. Al.1

“Definitive evidence has now been presented that personalized MRD testing can guide adjuvant treatment decisions, particularly for MRM-positive patients who clearly benefit from adjuvant chemotherapy,” said the principal investigator of the CIRCULATE-study. Japan, Dr. Takayuki Yoshino, from the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. “We view these findings as an important step in establishing MRD-guided adjuvant therapy as the standard of care for colorectal cancer patients worldwide.”

“Current guidelines recommend combination chemotherapy for all stage III CRC patients, but up to 40% are known to be cured by surgery alone. Our study demonstrates that MRD testing can help stratify and predict which patients are likely to benefit from systemic therapy,” mentioned Alexei Alessine, MD, vice president of medical affairs in oncology at Natera. “We are extremely pleased with these groundbreaking results from CIRCULATE-Japan and are optimistic that they may change practice guidelines.”

The full presentation, as presented at ASCO GI, is available here.

About Signera

will sign is a custom-designed circulating tumor DNA (ctDNA) test for treatment monitoring and evaluation of molecular residual disease (MRD) in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has received three breakthrough device designations from the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor informed, providing each individual with a personalized blood test tailored to the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy in detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess the amount of cancer remaining in the body, identify recurrences earlier and optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health and organ health. Our goal is to integrate personalized genetic testing and diagnostics into the standard of care to protect health and enable earlier, more targeted interventions that help lead longer, healthier lives. Natera’s tests are validated by over 100 peer-reviewed publications that demonstrate high accuracy. Natera operates laboratories that are ISO 13485 certified and CAP accredited under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, TX and San Carlos, California. For more information, visit www.natera.com.

Forward-looking statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and do not constitute a representation that Natera’s plans, estimates or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update any forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, than the results of clinical studies or others support the use of our product offerings, the impact of the results of such studies, our expectations regarding the reliability, accuracy, and performance of our tests, or the benefits of our tests and product offerings to patients, providers and payers Additional risks and uncertainties are discussed in more detail under “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings by Natera with the SEC sometimes. These documents are available at www.natera.com/investors and www.sec.gov.

contacts

Investor Relations: Mike Brophy, Chief Financial Officer, Natera, Inc., 510-826-2350

Media: Kate Stabrawa, Communications, Natera, Inc., [email protected]

The references

  1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultra-deep sequencing in patients with stage I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.

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