Profile: Natera Inc (NTRA.O)
20 Jun 2019
Natera, Inc., incorporated on January 26, 2007, is a diagnostics company. The Company is engaged in the discovery, development and commercialization of genetic testing services. The Company operates a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) providing a host of preconception and prenatal genetic testing services.
The Company's product offerings include its Panorama Non-Invasive Prenatal Test (NIPT) that screens for chromosomal abnormalities of a fetus with a blood draw from the mother; Horizon Carrier Screening (Horizon) to determine carrier status for a large number of severe genetic diseases that could be passed on to the carrier's children; Spectrum Pre-implantation Genetic Screening (PGS) and Spectrum Pre-implantation Genetic Diagnosis (PGD) to analyze chromosomal anomalies or inherited genetic conditions during an in vitro fertilization (IVF) cycle to select embryos with the probability of becoming healthy children; Anora Products of Conception (POC) test to analyze fetal chromosomes to understand the cause of miscarriage, and Non-Invasive Paternity Testing (PAT), to determine paternity by analyzing the fragments of fetal deoxyribonucleic acid (DNA) in a pregnant mother's blood and a blood sample from the alleged father(s). All testing is available principally in the United States and Europe. The Company also offers Constellation, a cloud-based software product that involves analysis of copy number variations (CNVs) and single nucleotide variants (SNVs) in a DNA mixture. It allows laboratory customers to gain access through the cloud to the Company's algorithms and bioinformatics in order to validate and launch tests based on the Company's technology.
The Company's technologies allow achieving a high signal to noise ratio when detecting fragments of DNA from samples as small as a single cell, which allows it to deliver screening tests with differentiated specificity, sensitivity and coverage. The Company's commercial tests assess the risk of a range of conditions, from a single blood draw, including common fetal aneuploidies, microdeletions, triploidy and inherited genetic conditions that could be passed on from parent to child. The Company sells its tests directly and partners with other clinical laboratories to distribute its tests globally. All of its products other than its Constellation cloud software product are laboratory developed tests (LDTs). Its multiplexed polymerase chain reaction (mmPCR) technology optimizes the behavior of primers in a reaction to generate a high-resolution measurement of thousands of DNA loci in patient samples. As a result, it can capture mutations from a single DNA fragment within a large background of extraneous DNA found in a patient's blood sample. The Company uses statistical techniques to combine the measurements of its molecular assays with its internal databases and the sources of publicly available genomic information to build detailed models of the genome of interest. This process includes the use of a statistical technique known as maximum likelihood estimation (MLE), which is used in other industries, such as in the conversion of a noisy transmitted analog communications signal to a digital format. Panorama helps physicians assess fetal genetic abnormalities by non-invasive screening for fetal chromosomal abnormalities, including Down syndrome, Edwards syndrome, Patau syndrome, Turner syndrome and triploidy, which result in intellectual disability, severe organ abnormalities and death of the fetus. Panorama can also identify fetal sex. Panorama is performed on a maternal blood sample, and can be performed as early as nine weeks into a pregnancy. Panorama starts with a simple blood draw from the mother, either in a doctor's office, in a laboratory or through a phlebotomist that may travel to the patient.
The Company extracts DNA from each sample, amplifies the specific single nucleotide polymorphisms (SNPs) that it is interested in measuring and then sequences the DNA using next-generation sequencing (NGS). Using its bioinformatics technology, the Company analyzes the DNA sequences to assess the state of the fetal genome, focusing on the SNP data, while incorporating public information from the Human Genome Project. Its bioinformatics algorithm builds billions of detailed models of the genetic state of the sample to determine the diagnosis. After Panorama generates its result, it provides the doctor or the laboratory with a report showing the risk that abnormalities are present in the fetus. Its Panorama microdeletions panel screens for five of the common genetic diseases caused by microdeletions: 22q11.2 deletion syndrome (Di George syndrome), 1p36 deletion, Angelman syndrome, Cri-du-chat syndrome and Prader-Willi syndrome.
The Company's PGS test screens embryos for chromosomal abnormalities prior to transfer of embryos created through IVF procedures, which have non-viable chromosomal abnormalities. This allows IVF physicians to select and transfer embryos with normal chromosome results and combines it with single embryo transfer. Its PGD test screens embryos for couples who are concerned about passing on a specific genetic defect to their child. Anora is its POC product, which tests miscarriage tissue in women who have experienced one or more miscarriages to determine whether there was an underlying genetic reason for the miscarriage(s). Its non-invasive prenatal paternity product allows a couple to establish paternity without waiting for the child to be born.
The Company competes with Laboratory Corporation of America Holdings, Illumina, F. Hoffman La-Roche Ltd, Counsyl, Inc., Quest Diagnostics Incorporated, Premaitha Health PLC, Beijing Genomics Institute, Berry Genomics Co., Ltd., Progenity, Inc., LifeCodexx AG, Synlab International GmbH, Agilent Technologies Inc., OPKO Health, Inc., Counsyl, Inc.; Good Start Genetics, Inc., Progenity; Recombine Inc., NxGen MDx LLC, AMAG Pharmaceuticals, Inc., PerkinElmer, Inc., Cryo-Cell International, Inc., CorCell Companies, Inc., LifeBankUSA, Guardant Health, Inc., Personal Genome Diagnostics, Inc., Foundation Medicine, Inc. and Genomic Health Inc.
201 Industrial Rd Ste 410
SAN CARLOS CA 94070-2396