New Study Shows Benefit of Using Signatera™ Technology for Personalized Monitoring in Gastrointestinal Cancer

SAN CARLOS, Calif., April 2, 2020 /PRNewswire/ -- 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.

More About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. This maximizes accuracy for 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. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Medicare has proposed insurance coverage for the use of Signatera in patients with Stage II or III colorectal cancer, and it is expected to finalize that coverage decision in mid-2020.

Signatera was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, [email protected]

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.

SOURCE Natera, Inc.

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