New Natera Publication Bolsters Evidence for Extended Surveillance with Signatera™ in Breast Cancer

Rhea-AI Summary

Natera, Inc. announced a new publication in JCO Precision Oncology showcasing the effectiveness of its Signatera test in detecting breast cancer recurrence early. The study involved 156 early-stage breast cancer patients followed for up to 12 years post-surgery. Signatera detected relapse 38 months earlier than imaging, with an 88.2% sensitivity rate. Patients testing positive for ctDNA had worse survival outcomes. The study emphasizes the importance of early recurrence detection and long-term monitoring in breast cancer patients.

Positive

• The study demonstrated that Signatera can detect breast cancer recurrence much earlier than traditional imaging methods, offering a critical window for early therapeutic intervention.

• Signatera showed an overall sensitivity of 88.2% in detecting relapse, with a median lead time of 10.5 months compared to imaging.

• Patients testing positive for ctDNA had significantly worse relapse-free survival and overall survival rates, highlighting the potential for early intervention based on molecular recurrence status.

Negative

• Patients with early-stage breast cancer experience a significant rate of local recurrence and distant metastases after primary treatment, emphasizing the need for improved monitoring methods.

• While Signatera offers early detection benefits, it may also lead to heightened anxiety in patients awaiting test results, potentially impacting their quality of life.

Expanded EBLIS study with up to 12 years of clinical follow-up across all subtypes of breast cancer

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced a new publication in JCO Precision Oncology reporting on the ability of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to detect recurrence early in patients with early-stage breast cancer. The full study can be found here.

The study evaluated a total of 1,136 prospectively collected and banked plasma samples from 156 early-stage breast cancer patients enrolled in the multi-site Exploratory Breast Lead Interval Study (EBLIS). Patients were followed for up to 12 years after surgery and adjuvant chemotherapy, with blood samples collected semi-annually and then analyzed using Signatera. Key findings include:

• Signatera detected relapse up to 38 months earlier than imaging (median lead time 10.5 months), with an overall sensitivity of 88.2% (30/34)
• Relapse-free survival (RFS) and overall survival (OS) were significantly worse in patients who were ctDNA-positive, regardless of hormone receptor and HER2 subtype (HR 52.98 and 53.69, respectively). In a multivariate analysis, ctDNA status was the most significant factor associated with RFS and OS.

“The EBLIS study shows that post-operative monitoring with Signatera can detect recurrence much earlier than scans, opening up a critical window for early therapeutic intervention and clinical trials focused on molecular recurrence,” said Charles Coombes, MD, PhD professor of medical oncology at the Imperial College London and principal investigator of the EBLIS study. “Additionally, we demonstrate the value of longitudinal testing in providing reassurance to breast cancer patients, as those who test serially ctDNA-negative show better clinical outcomes.”

Breast cancer is the most common cancer in women in the U.S. and the second leading cause of cancer death in women.¹ The current standard of care for most patients with early-stage breast cancer consists of surgery and adjuvant chemotherapy and/or endocrine therapy.^2,3 However, patients with early-stage breast cancer experience a rate of local recurrence of roughly 15% and distant metastases of 21% after primary treatment.⁴

“This expanded EBLIS study reinforces the importance of early recurrence detection with Signatera and the potential to improve care management for patients with breast cancer,” said Minetta Liu, MD, chief medical officer of oncology. “The findings also bolster the evidence for long-term monitoring of high-risk breast cancer patients, who often face late recurrences.”

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 200 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, 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 are not 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 the 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 whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

References

1. American Cancer Society. Cancer Facts and Figures 2024. Atlanta: American Cancer Society; 2024.
2. Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines® Insights: Breast Cancer, Version 4.2023. J Natl Compr Canc Netw. 2023;21(6):594-608.
3. Senkus E, Kyriakides S, Ohno S et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015;26 Suppl 5: v8-30.
4. Lyngholm CD, Laurberg T, Alsner J, Damsgaard TE, Overgaard J, Christiansen PM. Failure pattern and survival after breast conserving therapy. Long-term results of the Danish Breast Cancer Group (DBCG) 89 TM cohort. Acta Oncol. 2016;55(8):983-92.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240503118111/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

FAQ

What is the key finding of the EBLIS study involving Signatera in breast cancer patients?

The key finding of the study is that Signatera can detect breast cancer recurrence up to 38 months earlier than imaging methods.

Who conducted the EBLIS study evaluating Signatera?

The EBLIS study was conducted by Natera, Inc., a global leader in cell-free DNA and genetic testing.

What are the survival outcomes for patients testing positive for ctDNA?

Patients testing positive for ctDNA had significantly worse relapse-free survival and overall survival rates.

What is the significance of longitudinal testing in breast cancer patients?

Longitudinal testing with Signatera provides reassurance to breast cancer patients, with serially ctDNA-negative patients showing better clinical outcomes.

Why is early recurrence detection important in breast cancer management?

Early recurrence detection with Signatera can lead to timely therapeutic intervention and improve care management for patients with breast cancer.