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Natera, Inc. (Symbol: NTRA) is a leading diagnostic and research company based in San Carlos, CA, driven by a commitment to advance the science and application of prenatal testing. In the information age, medical diagnostics have lagged behind in adopting new technologies, but Natera is changing that narrative. The company specializes in preconception and prenatal genetic testing services, providing couples with crucial information throughout the pregnancy journey.
Natera offers a comprehensive range of tests, including Preimplantation Genetic Diagnosis (PGD) for IVF and Non-Invasive Prenatal Testing (NIPT). Their Panorama NIPT is particularly notable for its ability to screen for chromosomal abnormalities in a fetus, even in twin pregnancies, typically through a simple blood draw from the mother. Another significant product is the Horizon Carrier Screening (HCS), which determines carrier status for numerous severe genetic diseases that could be passed on to offspring.
The company's innovative approach leverages advances from the Human Genome Project and is powered by proprietary bioinformatics algorithms. This technology enables highly accurate genetic testing results. Natera's portfolio also includes the Signatera Molecular Residual Disease (MRD) Test, designed to detect circulating tumor DNA in cancer patients, helping to assess molecular residual disease and monitor recurrence. Additionally, the Prospera test assesses organ transplant rejection.
Through its pioneering genetic testing services and experienced genetic counseling, Natera provides valuable insights that help in informed decision-making for pregnancies and medical conditions. The company continues to make significant strides in the field of medical diagnostics, driven by a passion for innovation and excellence.
Natera has completed the VALID Study, the largest clinical validation of a commercial cell-free DNA test for lung transplantation. The study involved 204 plasma samples from 104 lung transplant recipients and was accepted as a late-breaking abstract for presentation at CHEST 2021 (October 17-20). This study highlights the significance of donor-derived cell-free DNA (dd-cfDNA) testing in improving patient outcomes. Natera's Prospera test has previously shown success in kidney and heart transplant assessments, indicating its potential in lung transplant situations as well.
Natera, Inc. (NASDAQ: NTRA) received a favorable ruling from the Delaware Federal District Court, invalidating all three patents asserted against it by CareDx. The court determined these patents are legally invalid due to their patent-ineligible subject matter. Natera anticipates this decision will withstand an appeal and is actively pursuing its own infringement claims against CareDx concerning its '658 and '724 patents. These patents are part of Natera's extensive organ health intellectual property portfolio, showcasing the company's contribution to cfDNA-based diagnostics.
Natera, Inc. (NASDAQ: NTRA) showcased new data on the Signatera personalized molecular residual disease (MRD) technology at the 2021 ESMO Congress. The studies highlighted include the predictive capacity of ctDNA for relapse in gastroesophageal cancers, the use of ctDNA dynamics in assessing treatment response in uveal melanoma, and the impact of CHIP mutations on patient outcomes. Results indicated ctDNA detected in 93.3% of samples at baseline for gastroesophageal cancer, and ctDNA reduction was linked to improved overall survival in uveal melanoma.
Natera (NASDAQ: NTRA) has launched Prospera with Quantification, a groundbreaking cfDNA test for kidney rejection analysis. This test uniquely reports three critical metrics — the quantity of donor-derived cfDNA (dd-cfDNA), the fraction of dd-cfDNA, and total cfDNA — enhancing sensitivity in detecting transplant rejection. A recent study published in JASN confirmed that the new test improved sensitivity from 78% to 100% in active rejection cases. The test is now commercially available, underlining Natera's commitment to innovation in transplantation.
Natera, Inc. (NASDAQ: NTRA) has partnered with NRG Oncology to utilize the Signatera personalized molecular residual disease (MRD) test in the CIRCULATE-US study, a significant clinical trial for early-stage colon cancer treatment. The trial will enroll about 2,000 patients and will assess MRD-guided chemotherapy strategies. Signatera aims to refine treatment approaches, reducing unnecessary chemotherapy for 20-25% of patients who may not benefit from it. This collaboration could enhance the role of ctDNA technology in cancer management and potentially improve patient outcomes.
Natera, Inc. (NASDAQ: NTRA) has announced the launch and clinical validation of the Prospera Heart test for heart transplant assessment, marking a significant extension of its technology beyond kidney transplants. The test boasts an impressive AUC of 0.844, reducing cost and complexity in patient monitoring. Collaborations with the University of Utah and UC San Diego validated the test using over 350 biopsy-matched samples. Furthermore, the Prospera Heart test will play a key role in the NIH-funded DTRT study, which is fully enrolled with over 2,000 dd-cfDNA timepoints.
Natera, a leader in cell-free DNA testing, announced participation in several investor conferences. CEO Steve Chapman and CFO Mike Brophy will discuss Natera's growth in the genetic testing sector and its impact on healthcare. Upcoming events include:
- Canaccord Genuity 41st Annual Growth Conference: August 11, 2021, 5:30 a.m. PT
- Wells Fargo Healthcare Conference: September 10, 2021, 8:20 a.m. PT
- Morgan Stanley 19th Annual Global Healthcare Conference: September 13, 2021, 8:45 a.m. PT
- Baird Global Healthcare Conference: September 15, 2021, 12:45 p.m. PT
Webcasts available at investor.natera.com.
Natera, Inc. (NASDAQ: NTRA) reported Q2 2021 financial results showing total revenues of $142 million, a 64.2% increase from $86.5 million in Q2 2020. Product revenues surged by 70.7% to $137.2 million, driven by 375,700 tests processed, up 60.5%. The company raised its 2021 revenue guidance to $600-620 million. However, net loss widened to $116 million from $59.6 million year-over-year, with operating expenses rising 98.7% to $181.2 million.
Natera (NASDAQ: NTRA) announced the initiation of a phase III trial, the ZEST study, evaluating its Signatera test for identifying early-stage breast cancer patients for treatment with GSK's PARP inhibitor, niraparib. This trial aims to assess the efficacy and safety of niraparib in 800 patients post-surgery or after adjuvant therapy. The FDA has designated Signatera as a Breakthrough Device for multiple indications, enhancing its role in personalized medicine for oncology.
Natera, a leader in cell-free DNA testing, will announce its second quarter 2021 results on August 5, 2021, post-market close. A conference call is scheduled for 1:30 p.m. PT to discuss financial results, business activities, and future outlook. This will provide investors with insights into Natera's financial performance and strategic direction.
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