Natera, Inc. is a clinical
genetic testing
Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or ...
company based in
Austin, Texas
Austin is the capital city of the U.S. state of Texas, as well as the county seat, seat and largest city of Travis County, Texas, Travis County, with portions extending into Hays County, Texas, Hays and Williamson County, Texas, Williamson co ...
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
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
CLIA P ...
(CLIA) in
San Carlos, California
San Carlos (Spanish for "St. Charles") is a city in San Mateo County, California, United States. The population is 30,722 per the 2020 census.
History
Native Americans
Prior to the Spanish arrival in 1769, the land of San Carlos was occupi ...
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 2010, the company introduced the Anora miscarriage (POC) test. Natera's advanced carrier screening test, Horizon, launched in 2012. The following year, 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
The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...
Global Select Market under the symbol "NTRA."
In 2017, Natera launched the Vistara single-gene NIPT. That same year, Natera introduced the Signatera molecular residual disease (MRD) test for research use only. The Signatera CLIA test was introduced for clinical use in 2019.
In 2018 Natera paid a $11 million fine to the department over allegations of improper billing and sales of Panorama to federal Healthcare services between the years of 2013 to 2016.
Natera launched the Prospera dd-cfDNA
transplant assessment test in 2019, and the Renasight kidney gene panel and the Empower
hereditary cancer
A cancer syndrome, or family cancer syndrome, is a genetic disorder in which inherited genetic mutations in one or more genes predispose the affected individuals to the development of cancers and may also cause the early onset of these cancers. Ca ...
test in 2020.
As of May 2021, Natera has performed over 3 million cell-free DNA tests. Natera's technology has also been written about in over 100 peer-reviewed journals and publications, including
''Nature'', ''
Science Magazine
''Science'', also widely referred to as ''Science Magazine'', is the peer-reviewed academic journal of the American Association for the Advancement of Science (AAAS) and one of the world's top academic journals.
It was first published in 1880, ...
'', and the ''
Journal of Clinical Oncology
The ''Journal of Clinical Oncology'' is a peer-reviewed medical journal published 3 times a month by the Lippincott Williams & Wilkins. It covers research on all aspects of clinical oncology. The journal was established in 1983 and the editor-in ...
''.
Products and services
Women's health
The Panorama NIPT is the only
single-nucleotide polymorphism
In genetics, a single-nucleotide polymorphism (SNP ; plural SNPs ) is a germline substitution of a single nucleotide at a specific position in the genome. Although certain definitions require the substitution to be present in a sufficiently lar ...
(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
Down syndrome or Down's syndrome, also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual dis ...
(trisomy 21) and
Edwards syndrome
Edwards syndrome, also known as trisomy 18, is a genetic disorder caused by the presence of a third copy of all or part of chromosome 18. Many parts of the body are affected. Babies are often born small and have heart defects. Other features in ...
(trisomy 18) as early as nine weeks. Panorama also tests for unique microdeletions and is the only test that can detect
zygosity
Zygosity (the noun, zygote, is from the Greek "yoked," from "yoke") () is the degree to which both copies of a chromosome or gene have the same genetic sequence. In other words, it is the degree of similarity of the alleles in an organism.
Mo ...
and fetal sex in twins.
Natera also offers Horizon, a
carrier-screening test that uses next-generation
sequencing
In genetics and biochemistry, sequencing means to determine the primary structure (sometimes incorrectly called the primary sequence) of an unbranched biopolymer. Sequencing results in a symbolic linear depiction known as a sequence which succ ...
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
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA in the bloodstream that is not associated with cells. ctDNA should not be confused with cell-free DNA (cfDNA), a broader term which describes DNA that is freely circulating in the blood ...
(ctDNA) assay built for molecular residual disease (MRD) detection and
cancer
Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...
recurrence monitoring. In 2020, Signatera received the
CE Mark
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ...
, as well as final
Medicare coverage in stage II-III
colorectal cancer
Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). Signs and symptoms may include blood in the stool, a change in bowel m ...
and draft coverage in
immunotherapy
Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...
response monitoring. Signatera has been clinically validated to detect colorectal cancer recurrence up to 16.5 months in advance of
radiologic imaging and early-stage
breast cancer
Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a re ...
up to two years earlier than imaging.
Organ health
The Prospera test is the first assay with high sensitivity to both
T-cell
A T cell is a type of lymphocyte. T cells are one of the important white blood cells of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell rec ...
-mediated and antibody-mediated rejection.
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
Kidney disease, or renal disease, technically referred to as nephropathy, is damage to or disease of a kidney. Nephritis is an inflammatory kidney disease and has several types according to the location of the inflammation. Inflammation can ...
and if there may be other at-risk relatives.
Constellation
Natera offers a cloud-based
bioinformatics
Bioinformatics () is an interdisciplinary field that develops methods and software tools for understanding biological data, in particular when the data sets are large and complex. As an interdisciplinary field of science, bioinformatics combi ...
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
{{Reflist
External links
Natera's homepage
Health care companies based in California
Companies based in San Carlos, California
Companies listed on the Nasdaq
2015 initial public offerings
Biotechnology companies of the United States
Genetic genealogy companies