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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) will present new data on its personalized tumor-informed molecular residual disease (MRD) test, Signatera, at the ESMO IO Virtual Congress on December 10, 2020. The study involves 581 muscle invasive urothelial carcinoma patients from the IMvigor010 trial, assessing adjuvant treatment with atezolizumab. Interim results indicate ctDNA-positive patients showed improved overall survival of 25.8 months with treatment versus 15.8 months with observation (HR=0.59). The findings underscore Signatera's potential for patient selection in personalized cancer therapy.
Natera (NASDAQ: NTRA) announced its participation in the 2020 virtual San Antonio Breast Cancer Symposium (SABCS) from December 8-11, 2020. The company will present new data on its Signatera tumor-informed circulating tumor DNA (ctDNA) assay. Highlights include two posters: one on Signatera as a predictive biomarker in the I-SPY2 Trial and the other on comprehensive plasma-based whole exome analysis in the Beyond BRCA study. These presentations emphasize Signatera's role in monitoring treatment response and addressing drug resistance in breast cancer.
Natera, Inc. (NASDAQ: NTRA) announced that the second-largest commercial health plan in the U.S. has expanded coverage for non-invasive prenatal testing (NIPT) to all singleton pregnancies. This follows recent coverage expansions by other major health plans, resulting in over 90% of commercially-covered lives now having average-risk NIPT coverage. Natera's unique SNP-based NIPT technology aims to enhance prenatal care and reduce false negatives and positives, significantly impacting health outcomes. The company's Panorama test is a leading NIPT, backed by extensive clinical evidence.
Natera, Inc. (NASDAQ: NTRA) announced that the largest health plan in the U.S. will now cover non-invasive prenatal testing (NIPT) for all pregnancies. This decision follows a recent guideline from the American College of Obstetricians and Gynecologists (ACOG), promoting aneuploidy screening for all patients. The expanded coverage addresses previous barriers to adoption, potentially increasing the average risk NIPT market, which remains underpenetrated. Natera aims for profitability in its Women's Health business by 2021, capitalizing on this expansion and the positive health outcomes associated with NIPT.
Natera (NASDAQ: NTRA) announced a study published in Annals of Oncology demonstrating its ctDNA assay, Signatera, can effectively monitor neoadjuvant chemotherapy (NAC) responses in breast cancer patients. The study involved 291 plasma samples from 84 patients, revealing that early ctDNA clearance is significantly associated with achieving pathologic complete response (pCR), which indicates better survival outcomes. The findings suggest Signatera could improve treatment decisions and outcomes for breast cancer patients, particularly in predicting metastatic recurrence.
Natera, Inc. (NASDAQ: NTRA) has appointed Dr. Monica Bertagnolli to its board of directors. Dr. Bertagnolli, a renowned oncology researcher and professor at Harvard Medical School, brings extensive clinical experience to the role. CEO Steve Chapman expressed confidence in her ability to drive the company’s vision of advancing MRD testing as a standard of care. Dr. Bertagnolli's involvement is expected to enhance Natera's innovation in ctDNA technology, particularly in the application of Signatera technology, which aims to improve patient outcomes in oncology.
Natera, Inc. (NASDAQ: NTRA) announced a live webcast presentation at the Canaccord Genuity Virtual MedTech & Diagnostics Forum on November 19, 2020, at 1:30 p.m. PT (4:30 p.m. ET). Mike Brophy, Chief Financial Officer, will discuss the company's latest developments. The webcast will be accessible live and archived on investor.natera.com.
Natera, a leader in cell-free DNA testing, aims to transform disease management, focusing on women’s health, oncology, and organ health.
Natera, Inc. (NASDAQ: NTRA) announced new data for its personalized molecular residual disease assay, Signatera, at the SITC 35th Annual Meeting, held from November 9-14, 2020. The presentations highlighted Signatera's capability in monitoring immunotherapy responses in colorectal and breast cancer. Key findings included early detection of treatment response dynamics via circulating tumor DNA (ctDNA) analyses, demonstrating the assay's utility in clinical decision-making and the monitoring of treatment efficacy.
Natera (NASDAQ: NTRA) reported strong Q3 2020 results with total revenues of $98.1 million, a 26% increase from Q3 2019, driven by a 39.5% rise in product revenues. The company processed 262,000 tests, up 31% year-over-year. Gross profit reached $46.3 million with a 47% gross margin. However, operating expenses grew to $102.1 million, leading to a net loss of $58.3 million, or ($0.72) per share. Natera raised its 2020 revenue guidance, expecting $380 million to $390 million in total revenues.
Natera, a leader in cell-free DNA testing, welcomes the ISPD's position statement endorsing cfDNA screening for twin pregnancies. This backing reinforces the clinical value of Non-Invasive Prenatal Testing (NIPT) for identifying autosomal trisomies. The statement emphasizes the importance of incorporating zygosity in NIPT interpretation, highlighting Natera's Panorama test's unique capability to assess zygosity and fetal fractions. This endorsement positions Natera favorably to expand its market leadership in NIPT.
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