On Juy 7, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, along with its collaborators, reported two distinct studies (one oral and one poster presentation) at the recent 2020 virtual ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer that took place July 1-4, 2020 (Press release, Natera, JUL 7, 2020, View Source [SID1234561729]).

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The studies highlight: a) the clinical validity of Signatera, a personalized and tumor-informed circulating tumor DNA (ctDNA) assay for identifying molecular residual disease (MRD) in patients with oligometastatic CRC; and b) a prospective trial, already in progress, that will measure the clinical outcomes of MRD-guided treatment in stage II-III CRC patients.

These presentations build upon a fast-growing set of evidence that Signatera MRD testing is valid and useful for guiding post-surgical treatment decisions in colorectal cancer (escalation or de-escalation of therapy), including for late-stage oligometastatic patients where surgical resection may lead to cure.

"Now that Signatera is being used in prospective interventional trials, we’re seeing confirmation that it can help inform treatment decisions after oligometastatic resection in the 20 percent to 30 percent of patients with metastatic CRC,"1-3 said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director for Oncology. "This clinical data suggest ctDNA testing is a highly accurate tool in guiding treatment and supports the advancement of our efforts with Signatera to improve cancer management."

Details about the abstracts are as follows:

Assigned ID: SO-34 | Oral Presentation

Presenter: Stacey A. Cohen, M.D.

Clinical Experience of a Personalized and Tumor-Informed Circulating Tumor DNA Assay for Minimal Residual Disease Detection in Oligometastatic Colorectal Cancer Patients

This study is a sub-analysis of the first large, real-world study using personalized MRD in 535 unique patients with Stage I-IV CRC, and is one of the first studies to evaluate ctDNA detection rates in late-stage oligometastatic CRC. The study found that ctDNA detection was significantly associated with stage of disease, demonstrating a detection rate of 100 percent in patients with active metastatic disease in a pre-surgical setting.

Assigned ID: P-120 | Poster Presentation

Presenter: Hiroki Yukami, M.D.

Prospective observational study monitoring circulating tumor DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan (Trial in Progress)

The poster presentation highlighted the GALAXY study design, a prospective, observational study, which is part of the CIRCULATE-Japan trial, organized by the National Cancer Center (NCC) Japan. The CIRCULATE-Japan trial is a multicenter, randomized trial that will investigate optimal ctDNA-guided treatment strategies for patients with Stage II-III CRC, particularly adjuvant chemotherapy decisions based on MRD status.

About Signatera

Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. 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’s 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 has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other FDA legal requirements for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. CAP accredited, ISO 13485 certified, and CLIA certified. © 2020 Natera, Inc. All Rights Reserved.