NTRA

Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera™ Heart dd-cfDNA Test for Heart Transplant Recipients

Retrieved on: 
Monday, April 8, 2024
Research, Surgery, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, General Health, Science, Biopsy, Reward, Plasma, International Society, Cohort (statistics), Physician, Risk, AUC, Nucleic acid thermodynamics, Patient, Journal, DNA, Lung transplantation, Heart transplantation, MD, NIH, NTRA, Hospital, Molecule, Bangladesh Technical Education Board, Medicare, Oportunidades, Annual general meeting, NPV

“We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera.

Key Points: 
  • “We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera.
  • That study showed the Prospera Heart test had an overall area under the curve (AUC) of 0.86 for identifying acute rejection in over 800 samples from 200 adults with heart transplants.
  • The DTRT-2 (DNA-Based Transplant Rejection Test) study, published recently in Pediatric Transplantation , was sponsored by the National Institutes of Health (NIH).
  • A total of 487 samples from 160 heart transplant recipients were evaluated, of which 78 were pediatric and 82 were adult patients.

Natera Announces Positive Surveillance Analysis from the Randomized Phase III IMvigor011 Trial in Muscle-Invasive Bladder Cancer

Retrieved on: 
Friday, April 5, 2024
Surgery, Genetics, Clinical Trials, Health Technology, Biotechnology, Other Health, Health, Pharmaceutical, Oncology, Congress, Cystectomy, CDX, Patient, Roche, DNA, DFS, EAU, Bladder cancer, MIBC, NTRA, Survival rate, MRD, FDA, Food, Pharmaceutical industry

The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.

Key Points: 
  • The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.
  • Sponsored by Genentech, a member of the Roche group, IMvigor011 is a global, double-blind, randomized, Phase III trial, in which high-risk MIBC patients are serially tested with Signatera for up to 12 months post cystectomy.
  • Patients who test Signatera MRD-positive at any point during the 12-month surveillance window are randomized to the anti-PDL1 atezolizumab (Tecentriq®) vs. placebo.
  • “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients.

Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer

Retrieved on: 
Monday, April 1, 2024
Research, Genetics, Clinical Trials, Biotechnology, Biometrics, Health, Pharmaceutical, Science, Oncology, NCI, Checkmate, Hematology, Immunotherapy, Cystectomy, Colorectal cancer, Patient, DNA, National Cancer Institute, Nature, Bladder cancer, MD, Medicine, NTRA, National Institutes of Health, Nivolumab, MRD, Safety, Bangladesh Technical Education Board, Multimedia, Recurrence, FDA, Transitional epithelium, PD-1, Medical imaging

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI), part of National Institutes of Health, today announced the launch of Alliance A032103 ( MODERN ), a randomized, phase II/III, biomarker-integrated trial.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI), part of National Institutes of Health, today announced the launch of Alliance A032103 ( MODERN ), a randomized, phase II/III, biomarker-integrated trial.
  • Alliance A032103 (MODERN) will utilize Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to help guide personalized treatment based on molecular status in patients diagnosed with muscle-invasive urothelial cancer (MIUC) after radical cystectomy.
  • Patients will be divided into two cohorts based on an initial assessment of MRD status.
  • “We are grateful to collaborate with the Alliance on this important study.”

Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Retrieved on: 
Monday, March 18, 2024
Science, Other Science, Biometrics, Biotechnology, Oncology, Health, Genetics, Clinical Trials, ACT, Cordeliers, Survival, Colorectal cancer, Patient, DNA, Observation, Standard of care, Doctor of Philosophy, MD, FOLFOX, Gastroenterology, Circulating tumor DNA, NTRA, CRC, MRD, Neoplasm, Nursing

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Key Points: 
  • The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.
  • Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).
  • While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.
  • “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”
    Natera has joined the study in progress.

New KDIGO Guideline Supports Genetic Testing for the Majority of CKD Patients to Establish Cause of Disease

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, Genetics, Clinical Trials, Research, Science, Biotechnology, Nephrology, Prevalence, Chronic kidney disease, Genetic testing, Disease, CKD, Kidney disease, Patient, CGC, Evaluation, DNA, NTRA, Guideline

The updated guideline includes consensus statements supporting the use of genetic testing to establish the cause of chronic kidney disease (CKD) for a majority of patients with this condition.

Key Points: 
  • The updated guideline includes consensus statements supporting the use of genetic testing to establish the cause of chronic kidney disease (CKD) for a majority of patients with this condition.
  • The KDIGO guideline, specifically in Practice Points 1.1.4.1 and 1.1.4.2, states that genetic tests should be used, among other factors, to establish cause for CKD, and that genetic testing can impact the clinical management of people with CKD.
  • The guideline also lists specific gene categories, aligned with Natera’s Renasight gene panel, that are actionable for CKD patients.
  • “KDIGO makes it clear that most CKD patients and healthcare providers would prefer to identify the underlying cause of disease, which should include a genetic diagnosis when such tests are available,” said Maggie Westemeyer, MS, CGC, and director of clinical genetic services at Natera.

Natera to Present New Data at the 2024 SGO Annual Meeting on Women’s Cancer, Following Recent Medicare Coverage Decisions in Ovarian and Breast Cancers

Retrieved on: 
Tuesday, March 12, 2024
Research, Women, Genetics, Clinical Trials, Biotechnology, Health, Consumer, Science, Oncology, Ovarian cancer, Patient, DNA, SGO, MD, Abstract, NTRA, Breast cancer, MRD, Gynecologic Oncology (journal), Medicare, Society of Gynecologic Oncology, Birth control

A total of seven abstracts will be presented, including two oral presentations and five poster presentations.

Key Points: 
  • A total of seven abstracts will be presented, including two oral presentations and five poster presentations.
  • The presentations will feature new data highlighting Signatera’s predictive and prognostic utility in ovarian cancer and other gynecologic malignancies.
  • “On the heels of receiving Medicare coverage for Signatera in ovarian cancer and for breast cancer in the neoadjuvant setting, we are thrilled to share new Signatera and Empower data with the gynecologic oncology community,” said Adam ElNaggar, MD, medical director of oncology at Natera.
  • “We believe this momentum is indicative of the growing clinical value our tests provide for patients across the continuum of gynecologic cancer care, and demonstrate our continued leadership in MRD.”
    Below is the full list of Signatera and Empower data presentations at the SGO Annual Meeting.

Natera Announces Commercial Coverage for Prospera™ Kidney and Prospera Heart™ from a Top BCBS Plan

Retrieved on: 
Thursday, March 7, 2024
Insurance, FDA, Genetics, Public Relations, Investor Relations, Communications, Professional Services, Cardiology, Health Insurance, General Health, Health, Cohort (statistics), Lung, Risk, Nucleic acid thermodynamics, Medicare, Patient, Policy, Heart, Kidney, ProActive, BCBS, Publication, DNA, NTRA

The coverage policy includes serial testing with Prospera to assess graft status and identify the risk of rejection following a kidney or heart transplant.

Key Points: 
  • The coverage policy includes serial testing with Prospera to assess graft status and identify the risk of rejection following a kidney or heart transplant.
  • “Improving long-term outcomes for this population starts with more accurate and non-invasive tools to identify potential graft issues earlier.”
    Natera and its academic partners have published significant peer-reviewed evidence supporting the clinical utility of Prospera.
  • In addition, Natera has completed enrollment in the PEDAL and MOTR trials.
  • These are both multi-site, prospective studies designed to provide novel evidence supporting the clinical utility of Prospera, with expected publication in 2024.

Natera to Participate in March Investor Conferences

Retrieved on: 
Thursday, February 29, 2024
Oncology, Health, Consumer, Women, Genetics, Pharmaceutical, Biotechnology, DNA, NTRA

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will participate in the following investor conferences in March.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will participate in the following investor conferences in March.
  • Tuesday, March 5 at 2:15 pm ET | 11:15 am PT in Orlando, FL
    Wednesday, March 6 at 9:50 am ET | 6:50 am PT in Boston, MA
    A live webcast and audio archive of each event may be accessed through the investor relations section of the Natera website at investor.natera.com .
  • Replays of the events will be available shortly following the conferences.

Natera Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
Biotechnology, Genetics, Health, Oncology, Investment, NTRA, GAAP, UBS, Ovarian cancer, Research, DNA, Video game

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported its financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported its financial results for the fourth quarter and year ended December 31, 2023.
  • Generated total revenues of $311.1 million in the fourth quarter of 2023, compared to $217.3 million in the fourth quarter of 2022, an increase of 43.2%.
  • Generated gross margins of 51.4% in the fourth quarter of 2023, compared to gross margins of 41.4% in the fourth quarter of 2022.
  • Performed approximately 97,500 oncology tests in the fourth quarter of 2023, compared to approximately 64,000 in the fourth quarter of 2022, an increase of 52.3%.

Natera Announces Next Phase of CareDx Patent Infringement Litigation Seeking Royalty For All Ongoing And Future AlloSure Tests

Retrieved on: 
Tuesday, February 27, 2024
Health Technology, Genetics, Health, Other Health, District court, Patent, DNA, NTRA

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the next phase of proceedings in its patent infringement litigation against CareDx.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the next phase of proceedings in its patent infringement litigation against CareDx.
  • The U.S. District Court for the District of Delaware will now determine if CareDx owes a royalty for future infringement related to ongoing and future AlloSure testing occurring after August 2023.
  • The jury found that CareDx’s AlloSure and AlloSeq tests infringed one of the two Natera patents asserted against CareDx and that all asserted claims of both patents are valid on various grounds.
  • Discovery and briefing for this next phase are expected to last through the end of summer 2024.