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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, Inc. (NASDAQ: NTRA) announced that Noridian, the Medicare Administrative Contractor for Northern California, has approved Medicare benefits for the serial use of the Signatera molecular residual disease (MRD) test in colorectal cancer patients. This coverage determination aligns with a recent positive decision from the CMS Molecular Diagnostics program, effective October 18, 2020. The Signatera test, designed for personalized monitoring of cancer, has received FDA Breakthrough Device Designation and demonstrates high sensitivity in detecting residual disease.
Natera, Inc. (Nasdaq: NTRA) announced the pricing of its underwritten public offering of 4,166,666 shares at $60.00 per share, expected to close on September 15, 2020. The underwriters have a 30-day option to purchase an additional 624,999 shares. J.P. Morgan, Morgan Stanley, Cowen, and SVB Leerink serve as joint book-running managers. The offering follows an effective shelf registration statement filed with the SEC on September 9, 2020. Natera aims to innovate in cell-free DNA testing with a focus on women's health, oncology, and organ health.
Natera, Inc. (NASDAQ: NTRA) will present at the Morgan Stanley 18th Annual Global Healthcare Conference on September 14, 2020, at 9:00 a.m. PT (12:00 p.m. ET). The webcast will feature insights from Steve Chapman, CEO, and Mike Brophy, CFO, discussing recent developments and business activities. Interested parties can access the live presentation and archived content through investor.natera.com. Natera specializes in cell-free DNA testing, focusing on women's health, oncology, and organ health.
Natera, Inc. (Nasdaq: NTRA) announced a proposed follow-on public offering of $250 million in common stock, with an additional $37.5 million in shares potentially available to underwriters. The offering is subject to market conditions and no assurance is given regarding its completion or terms. This follows the filing of an automatically effective shelf registration statement with the SEC. J.P. Morgan, Morgan Stanley, Cowen, and SVB Leerink will manage the offering, which aims to support Natera's mission in cell-free DNA testing.
Natera, Inc. (NASDAQ: NTRA) announced that the CMS Molecular Diagnostics Program has finalized a local coverage determination (LCD) for Medicare to cover its Signatera molecular residual disease (MRD) test in stage II and III colorectal cancer patients. This LCD aligns with a prior draft from August 2019 and includes two main uses: risk stratification after surgery and recurrence monitoring. Signatera can detect cancer recurrence up to 16.5 months earlier than standard imaging methods. This development is a significant milestone for Natera in transforming cancer care.
Natera, Inc. (NASDAQ: NTRA) announced the unblinding of its SMART clinical trial data, validating its AI-enhanced Panorama non-invasive prenatal test (NIPT). The study, involving over 18,000 patients, demonstrated improved accuracy for detecting aneuploidies and microdeletions, particularly the 22q deletion syndrome. Natera performed over 105,000 22q tests in Q2 2020, suggesting strong market demand. Positive payer coverage is anticipated due to favorable pricing from CMS. The company aims to influence guidelines to support universal screening for 22q deletion syndrome.
Natera, Inc. (NASDAQ: NTRA) announced a prospective, randomized controlled trial demonstrating the clinical utility of its Prospera test. The study, published in International Urology and Nephrology, showed that nephrologists using the Prospera test detected rejections more effectively than those in the control group. Key findings include a 300% increase in biopsy confirmation of rejection and a 137% improvement in treatment decisions preserving kidney function. The Prospera test enhances early detection and management post-kidney transplant, emphasizing its role in nephrology.
Natera, Inc. (NASDAQ: NTRA) has partnered with Massachusetts General Cancer Center to initiate a multi-center, Phase II clinical trial named LEADER, focusing on Ribociclib (Kisqali®) for ER-positive breast cancer treatment. The trial will assess tumor molecular response in patients with detectable circulating tumor DNA (ctDNA) post-surgery. Utilizing Natera's Signatera test, the study aims to identify minimally residual disease (MRD) and evaluate treatment effectiveness, potentially reducing relapse risks in early-stage breast cancer patients.
Natera, Inc. (NASDAQ: NTRA) announced the receipt of the CE mark for its Signatera test, a personalized ctDNA assay designed for molecular residual disease (MRD) assessment in cancer patients. This milestone allows Natera to distribute Signatera across Europe, supporting patient management and clinical research. The test has been validated in multiple cancer types and represents an advancement in cancer care, particularly in monitoring treatment effectiveness. With 3.7 million new cancer cases annually in Europe, the CE mark expands Natera's global reach in personalized cancer therapy.
Natera, Inc. (NASDAQ: NTRA) announced on August 18, 2020, that the American College of Obstetrics and Gynecology (ACOG) and Society of Maternal Fetal Medicine (SMFM) have updated their guidelines to recommend non-invasive prenatal testing (NIPT) for aneuploidy screening for all patients, irrespective of age. The guidelines recognize cfDNA testing's sensitivity and its applicability in twin pregnancies. The updated recommendation is anticipated to enhance NIPT's coverage and usage. Natera has a robust clinical backing, evidenced by 22 peer-reviewed publications and the SMART study, which aims to further validate NIPT's effectiveness.
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