COMPANY:

Natera

"Natera, Inc...announced the Company’s first commercial coverage policies for its molecular residual disease test, Signatera, including its first pan-cancer coverage policy for adjuvant, recurrence monitoring, and treatment monitoring. Effective March 1, 2023, Blue Shield of California now provides commercial coverage of Signatera for plan members diagnosed with any solid tumors....In addition, effective January 1, 2023, Blue Cross and Blue Shield of Louisiana is providing coverage of serial testing with Signatera for plan members diagnosed with colorectal and muscle invasive bladder cancer and for pan-cancer immunotherapy monitoring."

"Natera, Inc...announced that it has received written confirmation from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) that Natera’s Signatera molecular residual disease (MRD) test has met coverage requirements for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer. The coverage applies across all subtypes of the disease, including hormone receptor (HR)-positive, HER2-positive, and triple negative breast cancers. This decision adds to Medicare’s prior coverage of Signatera in colorectal cancer, muscle-invasive bladder cancer, and pan-cancer immunotherapy monitoring."

"LifeLabs is pleased to share the launch of Signatera, a highly sensitive, personalized molecular residual disease assay (MRD) test developed by Natera for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer."

"Natera, Inc...announced that new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be presented at the American Society of Clinical Oncology's 2023 Gastrointestinal Cancers Symposium (ASCO GI), taking place January 19 – 21, 2023 in San Francisco, California. The presentations will highlight findings on the utility of Signatera for MRD assessment in colorectal (CRC), esophageal, gastric and anal cancers, in a total of five presentations."

P=NA | N=1,039 | GALAXY (UMIN000039205) | "Natera, Inc...announced the publication of a new study in Nature Medicine, which demonstrates the ability of the Signatera molecular residual disease (MRD) test to identify patients with stage II-IV colorectal cancer (CRC) who are at an increased risk of recurrence and predict who is likely to benefit from adjuvant chemotherapy (ACT)....The paper describes results from the GALAXY arm of the ongoing CIRCULATE-Japan trial, which is one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC....Key takeaways include:Post-surgical MRD status was predictive of chemotherapy benefit.Patients who were MRD-positive four weeks after surgery (18%) derived significant benefit from ACT (adjusted HR 6.59, p-value <0.001).MRD-negative patients (82%) did not see a significant benefit from ACT (adjusted HR 6.59, p-value <0.001).MRD-negative patients (82%) did not see a significant benefit from ACT (p-value <0.167)."

"Speaking at the JP Morgan Healthcare Conference here on Tuesday, Natera CEO Steve Chapman provided some clarity on the firm’s plan to take its Signatera test through the regulatory process in the US...The liquid biopsy test, which identifies circulating tumor DNA, was launched in 2017, and the company has been building evidence over the years for its use in a variety of cancers."

"Foundation Medicine, Inc and Natera...launched an early access program for clinical use of FoundationOne^®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay. In addition, the investigational use only version of the test is now available for use in clinical trials...FoundationOne Tracker is now available through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023."

"Natera on Tuesday filed a lawsuit against NeoGenomics subsidiary Inivata, claiming infringement of a new patent it was issued that same day...In a complaint filed with the US District Court of Delaware, Natera alleged that Inivata has unlawfully used its patented technology, covered by US Patent No. 11,530,454, to create its Radar assay, a tumor-informed test for detecting and monitoring residual cancer in patient blood samples."

"Natera, Inc...announced the publication of a new study in JCO Precision Oncology highlighting the clinical utility of its personalized and tumor-informed molecular residual disease test, Signatera, for postoperative risk stratification and prediction of recurrence in patients with stage I-III esophageal and gastric cancers (EGCs)."

"Natera, Inc...plans to present new clinical data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, and its hereditary cancer test, Empower, at the 2022 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas...Natera will present two posters from the LEADER and I-SPY 2 clinical trials in HR+, HER2- breast cancer highlighting Signatera's ability to detect recurrence and facilitate treatment response monitoring. A third poster from a multi-center study of over 1,900 patients will describe how hereditary cancer screening with Empower at the time of imaging can help to identify patients who may benefit from cancer risk management."

P1/2 | N=146 | NCT02570308 | Sponsor: Immunocore Ltd | "Natera...announced the publication of a new study in Nature Medicine, which shows that its mPCR technology is able to assess response to tebentafusp in treatment-refractory metastatic uveal melanoma...The study reports results from a multi-center, single-arm, open-label phase 2 study of tebentafusp in 127 patients with previously treated metastatic uveal melanoma...Pre-treatment ctDNA levels are strongly correlated with tumor burden and prognosis; below-median levels had longer overall survival compared with the subset with above-median levels (HR 0.23). Reduction in ctDNA levels at week nine is associated with greater improvement in overall survival, even in patients with apparent radiographic progression (HR 0.47). The 1-year overall survival in patients with ctDNA clearance was 100% compared with 52% in those with increased ctDNA."

"Natera, Inc...announced that it was awarded a nationwide contract, effective Sept. 15, 2022, with the U.S. Department of Veterans Affairs (VA) National Precision Oncology Program, to provide minimal residual disease (MRD) and monitoring services with the company’s personalized and tumor-informed MRD test, Signatera."

"Natera, Inc...announced the publication of a manuscript in Gynecologic Oncology...validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian cancer (EOC). This study adds to the growing library of over 30 published clinical studies incorporating Signatera technology....The blinded, multi-site study analyzed 163 plasma samples from 69 patients with Stage I-IV disease across a range of histologies, including high-grade serous (54%), endometrioid (13%), clear cell (13%) and other (20%). Test performance was evaluated at multiple time points: pre-surgery, post-surgery prior to adjuvant treatment, and longitudinally every 3 months for up to 40 months after the completion of definitive therapy. With longitudinal testing, recurrence was detected with 100% sensitivity, 100% specificity, and an average lead time of 10 months ahead of imaging compared to 1 month for CA-125."

P=NA | N= 16,347 | "Complete clinical information was available for a subset of 417 patients, and showed that postoperative MRD-positive status was significantly associated with inferior recurrence-free survival. Patients who were MRD-negative showed no significant benefit from adjuvant chemotherapy, regardless of other risk factors such as stage, age or microsatellite instability status."

"Natera, Inc...announced that the Federal Circuit Court of Appeals affirmed the Delaware Federal District Court’s September 2021 decision that all three CareDx patents asserted against Natera are invalid for claiming patent-ineligible subject matter."

"Natera, Inc...announced that it has received written confirmation from the CMS Molecular Diagnostics Services Program (MolDX) that the Signatera molecular residual disease (MRD) test has met coverage requirements for patients with muscle invasive bladder cancer (MIBC), effective April 19, 2022."

"NSCLC: ctDNA data in stage I-III patients showed 82% detection pre-treatment and was able to identify 100% of relapses prior to radiographic imaging (5.4 mo lead time); Breast Cancer: Data from the largest longitudinal ctDNA cohort to date (>1100 samples) showed Signatera's ability to detect recurrence with high accuracy across all subtypes; Renal Cell: ctDNA dynamics were predictive of treatment outcome in metastatic RCC patients receiving targeted therapy (TKI), after just 6 weeks; Merkel Cell: First data showing the ability of Signatera as a surveillance tool in MCC patients regardless of MCPyV status."

P3 | N=2,591 | BEATRICE (NCT00528567) | Sponsor: Hoffmann-La Roche | P2 | N=4,000 | I-SPY (NCT01042379) | "The results demonstrate that ctDNA status in samples collected post-surgery provided independent prognostic value beyond the known risk factors of lymph node involvement, tumor size and presence of tumor infiltrating lymphocytes. 19.9% of patients with early-stage TNBC were found to have detectable ctDNA after surgery, which was strongly associated with inferior outcomes (IDFS and OS). Lead time between first ctDNA positivity and radiographic recurrence was 6.1 months at the median, ranging up to 30.5 months...in the I-SPY2 trial...In TNBC, early clearance of ctDNA after just three weeks of treatment was a significant predictor of pathologic complete response. Patients who were ctDNA-negative after NAC, in both subtypes, showed significantly improved distant recurrence-free survival, even among those patients who did not achieve pathologic complete response."

"Natera, Inc...announced new Signatera data from the prospective, multi-center CIRCULATE-Japan trial, presented by Dr. Eiji Oki of Kyushu University in an oral presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care...CIRCULATE-Japan is the largest molecular residual disease (MRD)-guided clinical trial with more than 3,300 stage I-IV colorectal cancer (CRC) patients enrolled to date."

"Natera, Inc...announced a milestone with over 100 sites initiated and 1,000 patients enrolled across the U.S. in its BESPOKE CRC study, a prospective, multi-center trial to measure the clinical impact of serial testing with Signatera in resectable CRC....The investigators plan to conduct an interim analysis later in 2022, for presentation at a future scientific congress."

"Natera, Inc...announced new data recently presented on the clinical utility of Signatera, its personalized and tumor-informed molecular residual disease (MRD) test, at the American Society of Clinical Oncology’s 2022 Gastrointestinal Cancers Symposium (ASCO GI). The oral presentation included an updated analysis from the landmark CIRCULATE-Japan trial analyzing a cohort of colorectal cancer (CRC) patients."

"A new judicial order this week has denied, in part, Guardant Health's motion to dismiss Natera's counterclaims to its initial false advertising suit, the first volley in what has since become a bidirectional legal battle, with each company making claims that the other has misled customers and the public about their liquid biopsy minimal residual disease assays, Guardant Reveal and Signatera."

"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."

"Natera, Inc...announced its latest findings presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 7-10, 2021. Natera is presenting two studies based on the use of Signatera in high-risk breast cancer patients."

"Invitae has filed a lawsuit against Natera in the US District Court for the District of Delaware, alleging that the firm infringes two of its patents covering DNA sequence assembly...The company has asserted that Natera has infringed and continues to infringe one or more claims of the ’308 and '863 patents by performing its Signatera cancer liquid biopsy test, which it launched in 2017."

"Natera, Inc...today announced that the CMS Molecular Diagnostics Services Program (MolDX) has issued a final local coverage determination (LCD) for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease (MRD) test....'Monitoring ctDNA kinetics with Signatera can identify treatment non-responders earlier than imaging alone, and independent of other biomarkers including PD-L1 and tumor mutational burden (TMB),'..."

"Natera, Inc...announced the publication of a new study in Clinical Cancer Research demonstrating the ability of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to assess tumor growth rates and predict patient survival in early-stage colorectal cancer (CRC)...The publication describes a prospectively-collected, multicenter study of 168 stage III CRC patients undergoing curative intent treatment, with longitudinal MRD assessment before and after surgery, and then at regular intervals throughout adjuvant chemotherapy (ACT) and surveillance for up to 3 years (n=1204 samples)."

"Volpara Health Technologies (VHT) has partnered with Natera to bring Natera's Empower Hereditary Cancer Test to Volpara customers throughout the US...The arrangement will see VHT integrate the test into its software workflow to give women greater access to comprehensive genetic testing services in different clinical settings."

P=NA, N=1,155; "This study used Signatera for the detection and quantification of ctDNA in a prospective real-world cohort of 886 plasma samples from 269 patients with gastroesophageal cancer. Serial time points were collected in a subset of patients to monitor ctDNA levels after curative intent therapy. Analysis showed tumor-informed ctDNA status is highly predictive of relapse in patients with stage I-IV disease, with ctDNA detected in 93.3% of samples at baseline."

“Natera, Inc….announced an agreement with NRG Oncology, a National Cancer Institute (NCI)-funded group, to use the Signatera personalized molecular residual disease (MRD) test in NRG-GI008: Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US), a prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early stage colon cancer. The study will enroll approximately 2,000 patients with stage II or III colon cancer after resection.”

"Natera, Inc...announced that the first patient has been screened in a new phase III trial that uses its personalized, tumor-informed molecular residual disease (MRD) test, Signatera, to identify early-stage breast cancer patients eligible for investigational treatment with GSK's PARP inhibitor niraparib (ZEJULA)."

P=NA, N=20; "Natera,Inc...announced a new peer-reviewed paper published in Gastroenterology validating its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, in resected esophageal adenocarcinoma...Signatera detected recurrence with a sensitivity of 80% (4/5). The only missed recurrence had the last sample drawn two years before recurrence. The specificity was 100% (12/12) and the PPV was 100%."

"Natera,Inc...today announced the publication of a new peer-reviewed study validating its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, for use in oligometastatic colorectal cancer (oligo mCRC). Signatera has now been featured in 14 peer-reviewed publications...A new study published in JCO Precision Oncology presents an analysis from the prospective PREDATOR clinical trial, following 112 patients with oligo mCRC who underwent surgical resection with curative intent...The study validates Signatera’s high sensitivity and specificity in identifying the patients most likely to relapse without additional treatment. It is also Natera’s first major publication in CRC to prospectively assess overall survival in MRD-positive and negative patients, setting an important new standard for test performance and evidence quality."

"TomaLab said on Tuesday that it has signed an agreement with Natera to distribute three of that firm's cell-free DNA tests in Italy. Under the terms of the deal, Busto Arsizio, Italy-based TomaLab will distribute Natera's Panorama noninvasive prenatal test, Signatera circulating tumor DNA test for cancer treatment monitoring and minimal residual disease assessment, and Prospera test for assessing transplant rejection."

"Natera, Inc...and BGI Genomics Co., Ltd...today announced the launch of the BGI/Natera Signatera Assay which is now available to biopharmaceutical customers and clinicians across China...Natera’s Signatera® assay, now offered in partnership with BGI,1 has been utilized in numerous clinical studies across non-small cell lung, bladder, breast and colorectal cancers, to identify molecular residual disease (MRD) up to two years earlier than standard imaging. The test is now available in China under the Chinese brand name "Tumor MRD Customized Detection (HuaJianWei® for short)."

"Natera,Inc...today announced that the Centers for Medicare & Medicaid Services (CMS) has granted ADLT status for the Signatera molecular residual disease (MRD) test...Obtaining ADLT status confirms that Signatera meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014 (PAMA). The initial ADLT rate established by CMS is $3,500 for each Signatera assay used in the recurrence monitoring setting."

"Natera,Inc...today announced the publication of a new study in Nature, validating the ability of its personalized and tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, to predict outcomes with immunotherapy in a randomized clinical trial...publication that shows the predictive capabilities of a molecular residual disease (MRD) test in a large, randomized, multi-center study....'In this study, we show that personalized ctDNA analysis is highly accurate not only for identifying molecular residual disease, but also for predicting treatment outcomes with immunotherapy,' said Thomas Powles, M.D..."

"Foundation Medicine, Inc. and Natera, Inc...today announced the launch of the research use version of FoundationOne® Tracker, Foundation Medicine’s personalized circulating tumor DNA (ctDNA) monitoring assay. FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in ctDNA monitoring."

"Natera, In...today announced it has been sued by Guardant Health, in an attempt to stop Natera from exposing Guardant Reveal’s™ true test performance and the differences between tumor-informed and tumor-naive molecular residual disease (MRD) tests...Natera has filed a claim against Guardant in the U.S. District Court for the Western District of Texas, (Docket No.6:21-cv-00540), alleging that Guardant used false and misleading claims to deceive physicians about the performance capabilities of its MRD test, in violation of the Lanham Act. Guardant’s MRD test performance claims are incomplete or unsupported by clinical evidence, and can be misinterpreted by physicians and patients."

"Guardant Health, Inc...today filed a lawsuit against Natera, Inc. for false advertising, unfair competition, and unlawful trade practices, relating to misleading statements Natera has made about its own products and the performance of Guardant Health’s new oncology test, Guardant Reveal™...Guardant Health asked the federal court in San Francisco, California for an injunction preventing Natera from continuing to make these false or misleading statements and requiring Natera to take corrective actions."

"Natera, Inc...announced it will present new clinical data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the 2021 American Society of Clinical Oncology (ASCO) annual meeting...Two additional studies were presented at the 2021 American Association for Cancer Research (AACR) annual meeting that took place April 9-14, 2021. At ASCO, Natera will present four posters highlighting the use of Signatera in new indications including multiple myeloma. It will also unveil new colorectal cancer data from the CIRCULATE-Japan trial, the largest prospective MRD study to date."

P=NA, N=400; CIRCULATE-Japan; "Natera, Inc...announced initial results from the CIRCULATE-Japan trial...Part of CIRCULATE-Japan, the prospective, observational GALAXY study uses Natera's personalized and tumor-informed circulating tumor DNA (ctDNA) test, Signatera™, to monitor MRD status in patients with stage II-IV or relapsed colorectal cancer....Pre-surgical ctDNA detection rates of 95% in stage II-III disease and greater than 90% overall; Longitudinal relapse sensitivity of 92%, which has improved to >93% in the most recent analysis. Updated results will be presented at future conferences in mid-2021."