January 19, 2022
Natera to Present Latest Signatera™ MRD Data in Colorectal and Pancreatic Cancers at the ASCO GI Symposium 2022, and Host Special Investor Call

Oral presentations to include largest analysis to date from the prospective CIRCULATE-Japan study and results from first study showing clinical utility of Signatera in pancreatic cancer

AUSTIN, Texas, Jan. 19, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, today announced the company, along with its collaborators, will present new data on Natera's personalized, tumor-informed molecular residual disease (MRD) test, Signatera, at the American Society of Clinical Oncology's 2022 Gastrointestinal Cancers Symposium (ASCO GI), taking place January 20 – 22, 2022.

Natera has two oral presentations and four collaborative poster presentations highlighting clinical findings on the performance of Signatera across colorectal (CRC), pancreatic and anal cancers. The oral presentations include an interim analysis from the GALAXY cohort of the CIRCULATE-Japan trial, based on 12-month outcomes from more than 1,000 patients, demonstrating how MRD testing can help predict treatment benefit for CRC patients post-surgery, regardless of stage. A second oral presentation addresses results from the first major study on the utility of MRD testing for patients with pancreatic cancer, compared to the standard of care biomarker CA19-9.

"The predictive data coming out of CIRCULATE-Japan is exceptional, and we think it has the potential to transform clinical practice in CRC," said Solomon Moshkevich, general manager of oncology at Natera. "We also look forward to presenting high-impact data from our pancreatic and other GI studies, further expanding the pan-cancer utility of Signatera's personalized and tumor-informed method."

Natera and its collaborators will present the following studies:

Oral Abstract Session C: Cancers of the Colon, Rectum and Anus |
Presenter: Masahito Kotaka, M.D., Ph.D. | Jan. 22, 11:00 AM - 12:30 PM PST  
Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan

Oral Abstract Presentation: Emerging Roles of ctDNA on the Horizon of GI Cancers |
Presenter: Gregory Botta, M.D., Ph.D. | Jan. 20, 3:30 PM - 5:00 PM PST
Association of personalized and tumor-informed ctDNA with patient survival outcomes in pancreatic adenocarcinoma

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Georges Azzi, M.D. | Jan. 22, 6:30 AM - 7:55 AM PST
Circulating tumor DNA-based molecular residual disease detection and recurrence monitoring in patients with advanced or metastatic anal squamous cell carcinoma

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: RuoBing Xue, M.D. | Jan. 22, 6:30 AM - 7:55 AM PST
Prospective study of the correlation of ctDNA with pathologic complete remission (pCR) and other efficacy outcomes in rectal cancer patients undergoing neoadjuvant chemotherapy and radiation

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Sherise Rogers, M.D., M.P.H. | Jan. 22, 6:30 AM - 7:55 AM PST
A phase II randomized therapeutic optimization trial for subjects with refractory metastatic colorectal cancer using circulating tumor DNA (ctDNA): Rapid 1 trial

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Marwan Fakih, M.D. | Jan. 22, 6:30 AM - 7:55 AM PST
Exploratory biomarker analyses of the single-arm, phase 2 study of regorafenib plus nivolumab in patients (pts) with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) colorectal cancer (CRC)

Additionally, Natera will host an investor call to discuss ASCO GI results:

Event:

ASCO GI Conference Data Review



Date:

Monday, Jan. 24, 2022 



Time:

1:30 p.m. PT (4:30 p.m. ET)



Live Dial-In:

(877) 823-0171, Domestic

(617) 500-6932, International



Password:

7697903



Webcast:

https://edge.media-server.com/mmc/p/ctspf694

A webcast replay will be available at investor.natera.com.

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 both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. 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 Signatera's 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. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help 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 aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. 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 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 tests, or of the benefits of our tests and product offerings to patients, providers and payers, or coverage and reimbursement determinations from third-party 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., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., pr@natera.com

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/natera-to-present-latest-signatera-mrd-data-in-colorectal-and-pancreatic-cancers-at-the-asco-gi-symposium-2022-and-host-special-investor-call-301463554.html

SOURCE Natera, Inc.

Oral presentations to include largest analysis to date from the prospective CIRCULATE-Japan study and results from first study showing clinical utility of Signatera in pancreatic cancer

AUSTIN, Texas, Jan. 19, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, today announced the company, along with its collaborators, will present new data on Natera's personalized, tumor-informed molecular residual disease (MRD) test, Signatera, at the American Society of Clinical Oncology's 2022 Gastrointestinal Cancers Symposium (ASCO GI), taking place January 20 – 22, 2022.

Natera has two oral presentations and four collaborative poster presentations highlighting clinical findings on the performance of Signatera across colorectal (CRC), pancreatic and anal cancers. The oral presentations include an interim analysis from the GALAXY cohort of the CIRCULATE-Japan trial, based on 12-month outcomes from more than 1,000 patients, demonstrating how MRD testing can help predict treatment benefit for CRC patients post-surgery, regardless of stage. A second oral presentation addresses results from the first major study on the utility of MRD testing for patients with pancreatic cancer, compared to the standard of care biomarker CA19-9.

"The predictive data coming out of CIRCULATE-Japan is exceptional, and we think it has the potential to transform clinical practice in CRC," said Solomon Moshkevich, general manager of oncology at Natera. "We also look forward to presenting high-impact data from our pancreatic and other GI studies, further expanding the pan-cancer utility of Signatera's personalized and tumor-informed method."

Natera and its collaborators will present the following studies:

Oral Abstract Session C: Cancers of the Colon, Rectum and Anus |
Presenter: Masahito Kotaka, M.D., Ph.D. | Jan. 22, 11:00 AM - 12:30 PM PST  
Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan

Oral Abstract Presentation: Emerging Roles of ctDNA on the Horizon of GI Cancers |
Presenter: Gregory Botta, M.D., Ph.D. | Jan. 20, 3:30 PM - 5:00 PM PST
Association of personalized and tumor-informed ctDNA with patient survival outcomes in pancreatic adenocarcinoma

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Georges Azzi, M.D. | Jan. 22, 6:30 AM - 7:55 AM PST
Circulating tumor DNA-based molecular residual disease detection and recurrence monitoring in patients with advanced or metastatic anal squamous cell carcinoma

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: RuoBing Xue, M.D. | Jan. 22, 6:30 AM - 7:55 AM PST
Prospective study of the correlation of ctDNA with pathologic complete remission (pCR) and other efficacy outcomes in rectal cancer patients undergoing neoadjuvant chemotherapy and radiation

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Sherise Rogers, M.D., M.P.H. | Jan. 22, 6:30 AM - 7:55 AM PST
A phase II randomized therapeutic optimization trial for subjects with refractory metastatic colorectal cancer using circulating tumor DNA (ctDNA): Rapid 1 trial

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Marwan Fakih, M.D. | Jan. 22, 6:30 AM - 7:55 AM PST
Exploratory biomarker analyses of the single-arm, phase 2 study of regorafenib plus nivolumab in patients (pts) with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) colorectal cancer (CRC)

Additionally, Natera will host an investor call to discuss ASCO GI results:

Event:

ASCO GI Conference Data Review



Date:

Monday, Jan. 24, 2022 



Time:

1:30 p.m. PT (4:30 p.m. ET)



Live Dial-In:

(877) 823-0171, Domestic

(617) 500-6932, International



Password:

7697903



Webcast:

https://edge.media-server.com/mmc/p/ctspf694

A webcast replay will be available at investor.natera.com.

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 both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. 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 Signatera's 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. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help 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 aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. 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 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 tests, or of the benefits of our tests and product offerings to patients, providers and payers, or coverage and reimbursement determinations from third-party 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., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., pr@natera.com

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/natera-to-present-latest-signatera-mrd-data-in-colorectal-and-pancreatic-cancers-at-the-asco-gi-symposium-2022-and-host-special-investor-call-301463554.html

SOURCE Natera, Inc.