Company:Natera
 | This article may have been created or edited in return for undisclosed payments, a violation of Wikipedia's terms of use. (June 2021) |
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| Type | Public |
|---|---|
| NASDAQ: NTRA Russell 2000 Component | |
| Industry | Genetic testing |
| Headquarters | San Carlos, California |
Key people | Steve Chapman (CEO) Rishi Kacker (CTO) Matthew Rabinowitz (Executive Chairman) |
| Revenue |  US$ $391 million (2020) |
| Website | www.natera.com |
Natera, Inc. is a clinical genetic testing company based in Austin, Texas that specializes in non-invasive, cell-free DNA (cfDNA) testing technology, with a focus on women’s health, cancer, and organ health. Natera’s proprietary technology combines novel molecular biology techniques with a suite of bioinformatics software that allows detection down to a single molecule in a tube of blood. Natera operates CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas.
History
Natera (previously Gene Security Network) was founded by Matthew Rabinowitz and Jonathan Sheena in 2004. Natera launched its first product, the Spectrum preimplantation genetic test, in 2009.
In 2013, Natera launched the Panorama non-invasive prenatal test (NIPT).
In July 2015, Natera conducted an initial public offering of common stock at a price of $18.00 per share. The shares trade on the Nasdaq Global Select Market under the symbol "NTRA."[1]
In 2017, Natera launched the Signatera residual disease test for research use only and later for clinical use in 2019. Natera launched the Prospera transplant assessment test in 2019, and the Renasight kidney gene panel and the Empower hereditary cancer test in 2020.
Natera has performed over 3 million cell-free DNA tests to date,[when?] and its technology platform has been used in over 90 countries worldwide. Natera's technology has also been written about in over 50 peer-reviewed journals and publications, including Nature, Science Magazine, and the Journal of Clinical Oncology.
Products and services
Women's health
The Panorama NIPT is the only single-nucleotide polymorphism (SNP)-based NIPT. The test analyzes fetal DNA found in the mother's blood to reveal a baby's risk for genetic disorders such as Down syndrome (trisomy 21) and Edwards syndrome (trisomy 18) as early as nine weeks.[2] Panorama also tests for unique microdeletions[3] and is the only test that can detect zygosity and fetal sex in twins.[4]
Natera also offers Horizon, a carrier-screening test that uses next-generation sequencing to provide carrier status for up to 274 genetic conditions. Additionally, Natera offers the Anora products of conception (POC) miscarriage test, the Spectrum preimplantation genetic screening and diagnosis test, and the Vistara single-gene prenatal screening test. In 2020, Natera launched Empower, a hereditary cancer test that screens for up to 53 genes associated with increased risk for common hereditary cancers.
Oncology
Signatera is the first circulating tumor DNA (ctDNA) assay built for molecular residual disease (MRD) detection and cancer recurrence monitoring. The test is available for clinical and research use, and in 2019, was granted a Breakthrough Device designation by the FDA. In 2020, Signatera received the CE Mark, as well as final Medicare coverage in stage II-III colorectal cancer and draft coverage in immunotherapy response monitoring. Signatera has been clinically validated to detect colorectal cancer recurrence up to 16.5 months in advance of radiologic imaging[5] and early-stage breast cancer up to two years earlier than imaging.[6] In 2020, a study published in Nature Cancer demonstrated Signatera's ability to evaluate tumor response to immunotherapy in 25 different types of solid cancer.[7]
Organ health
The Prospera test uses cfDNA technology to identify allograft rejection non-invasively and with high precision and accuracy,[8][9] without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It is the first assay with high sensitivity to both T-cell-mediated and antibody-mediated rejection.[8][9] In December 2019, the test received final Medicare coverage. In 2020, Natera launched Renasight, a test to determine if there is a genetic cause for an individual's kidney disease and if there may be other at-risk relatives.
Constellation
Natera offers a cloud-based bioinformatics platform called Constellation, allowing laboratories to access and use Natera's technology in their own facilities. Constellation is currently only available outside of the United States.
References
- ↑ "NTRA Real-Time Quotes". https://www.nasdaq.com/market-activity/stocks/ntra/real-time.
- ↑ "Natera Launches Noninvasive Prenatal Test; Quest to Offer in Limited Areas by March, Nationwide in April". https://www.genomeweb.com/clinical-genomics/natera-launches-noninvasive-prenatal-test-quest-offer-limited-areas-march-nation.
- ↑ Wapner, Ronald J.; Babiarz, Joshua E.; Levy, Brynn; Stosic, Melissa; Zimmermann, Bernhard; Sigurjonsson, Styrmir; Wayham, Nicholas; Ryan, Allison et al. (2015-03-01). "Expanding the scope of noninvasive prenatal testing: detection of fetal microdeletion syndromes". American Journal of Obstetrics and Gynecology 212 (3): 332.e1–332.e9. doi:10.1016/j.ajog.2014.11.041. ISSN 0002-9378. PMID 25479548. https://www.sciencedirect.com/science/article/pii/S0002937814023746.
- ↑ Norwitz, Errol R.; McNeill, Gabriel; Kalyan, Akshita; Rivers, Elizabeth; Ahmed, Ebad; Meng, Ling; Vu, Phikhanh; Egbert, Melissa et al. (July 2019). "Validation of a Single-Nucleotide Polymorphism-Based Non-Invasive Prenatal Test in Twin Gestations: Determination of Zygosity, Individual Fetal Sex, and Fetal Aneuploidy". Journal of Clinical Medicine 8 (7): 937. doi:10.3390/jcm8070937. PMID 31261782.
- ↑ Reinert, Thomas; Henriksen, Tenna Vesterman; Christensen, Emil; Sharma, Shruti; Salari, Raheleh; Sethi, Himanshu; Knudsen, Michael; Nordentoft, Iver et al. (2019-08-01). "Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer". JAMA Oncology 5 (8): 1124–1131. doi:10.1001/jamaoncol.2019.0528. ISSN 2374-2437. PMID 31070691.
- ↑ Coombes, Raoul Charles; Page, Karen; Salari, Raheleh; Hastings, Robert K.; Armstrong, Anne; Ahmed, Samreen; Ali, Simak; Cleator, Susan et al. (2019-07-15). "Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence". Clinical Cancer Research 25 (14): 4255–4263. doi:10.1158/1078-0432.CCR-18-3663. ISSN 1078-0432. PMID 30992300. https://clincancerres.aacrjournals.org/content/25/14/4255.
- ↑ Bratman, Scott V.; Yang, S. Y. Cindy; Iafolla, Marco A. J.; Liu, Zhihui; Hansen, Aaron R.; Bedard, Philippe L.; Lheureux, Stephanie; Spreafico, Anna et al. (September 2020). "Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab". Nature Cancer 1 (9): 873–881. doi:10.1038/s43018-020-0096-5. ISSN 2662-1347. https://www.nature.com/articles/s43018-020-0096-5.
- ↑ 8.0 8.1 Sigdel, Tara K.; Archila, Felipe Acosta; Constantin, Tudor; Prins, Sarah A.; Liberto, Juliane; Damm, Izabella; Towfighi, Parhom; Navarro, Samantha et al. (January 2019). "Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR". Journal of Clinical Medicine 8 (1): 19. doi:10.3390/jcm8010019. PMID 30583588.
- ↑ 9.0 9.1 Bloom, Roy D.; Bromberg, Jonathan S.; Poggio, Emilio D.; Bunnapradist, Suphamai; Langone, Anthony J.; Sood, Puneet; Matas, Arthur J.; Mehta, Shikha et al. (2017-07-01). "Cell-Free DNA and Active Rejection in Kidney Allografts". Journal of the American Society of Nephrology 28 (7): 2221–2232. doi:10.1681/ASN.2016091034. ISSN 1046-6673. PMID 28280140.
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