Natera, Inc. operates as a diagnostics company with proprietary molecular and bioinformatics technology that it is applying to change the management of disease worldwide.
The company's cell-free DNA, or cfDNA, technology combines its novel molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell, with the company's statistical algorithms which incorporate data available from the broader scientific community to identify genetic va...
Natera, Inc. operates as a diagnostics company with proprietary molecular and bioinformatics technology that it is applying to change the management of disease worldwide.
The company's cell-free DNA, or cfDNA, technology combines its novel molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell, with the company's statistical algorithms which incorporate data available from the broader scientific community to identify genetic variations covering a wide range of serious conditions with high accuracy and coverage. The company intends to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier and more targeted interventions that help lead to longer, healthier lives.
The company focuses on applying its technology to three main areas of healthcare - women's health, oncology and organ health. Since 2009, the company has launched a comprehensive suite of products to improve patient care outcomes in these areas. In the women's health space, the company develops and commercializes non- or minimally- invasive tests to evaluate risk for, and thereby enable early detection of, a wide range of genetic conditions, such as Down syndrome. In oncology, the company commercializes, among others, a personalized blood-based DNA test to detect molecular residual disease, or MRD, and monitor for disease recurrence across a broad range of cancer types. The company's third area of focus is organ health, where the company offers tests to assess kidney, heart, and lung transplant rejection as well as genetic testing for chronic kidney disease. The company intends to continue to enhance its existing products, expand the company's product portfolio, and launch new products in the future. The company seeks to enable even wider adoption of the company's technology through the company's global cloud-based distribution model. In addition to the company's direct sales force in the United States, the company has a global network of over 100 laboratory and distribution partners, including many of the largest international laboratories. The company is committed to generating peer-reviewed clinical evidence for the company's tests, and have 85 peer-reviewed publications in women's health, over 60 in oncology, and over 30 in organ health.
Solution
The company's approach combines proprietary molecular biology and computational techniques to measure genomic variations in tiny amounts of DNA, as small as a single cell. The company's core technology has, to date, been proven across these three diverse fields of women's health, oncology and organ health.
The company's molecular biology techniques are based on measuring thousands of SNPs simultaneously using massively multiplexed polymerase chain reaction, or mmPCR, to multiplex, or target, many thousands of regions of the genome simultaneously in a single test reaction. The company's method avoids losing molecules, which can happen when samples are split into separate reaction tubes, so that all relevant variants can be detected. To make sense of the resulting deep and rich set of biological data and deliver a test result, the company has developed computationally intensive algorithms that combine the data generated by mmPCR with the company's internal databases and the vast and growing sources of publicly available genomic information to build highly detailed models of the genomic regions of interest. The company's technologies allow the company to achieve a high signal-to-noise ratio when detecting fragments of DNA at frequencies as low as a single copy, which allows the company to deliver tests with a high degree of specificity and sensitivity. Furthermore, the company's tests can be applied to assess a range of conditions and disease types, including common fetal aneuploidies, microdeletions, triploidy, and inherited genetic conditions that could be passed on from parent to child; a broad range of cancer types; rejection of heart, lung, and kidney transplants; and genetic bases of kidney disease.
The company's approach represents a fundamental advance in molecular biology. In women's health, this approach is distinct from the approach employed with other commercially available NIPTs, which use first-generation 'quantitative', or counting, methods to compare the relative number of sequence reads from a chromosome of interest to a reference chromosome. Based on data published in the journals Obstetrics & Gynecology, American Journal of Obstetrics & Gynecology, Prenatal Diagnosis, and others, Panorama is the most accurate NIPT commercially available in the United States. In oncology, with the company's Signatera circulating tumor DNA, or ctDNA, test that is custom designed for, informed by and specific to, the tumor DNA for each patient, the company has demonstrated the ability to detect ctDNA with a high degree of sensitivity and specificity. In organ health, the company has demonstrated the ability of its technology to measure the fraction of cell-free DNA that is donor-derived, or dd-cfDNA, which is DNA that is shed from a transplanted organ into circulation, each demonstrating a high area under the curve, or AUC, in validation studies in each of heart, lung, and kidney.
The company's technology is compatible with standard equipment used globally and a range of next generation sequencing, or NGS, platforms, and the company has optimized its algorithms to enable laboratories around the world to run tests locally and access the company's algorithms in the cloud using its Constellation platform. The company sells its tests directly and partner with other clinical laboratories to distribute the company's tests globally. All of the company's products other than its Constellation cloud software product are laboratory developed tests, or LDTs. The company performs commercial testing in its CLIA-certified laboratories.
Women's Health
The company provides testing to support a spectrum of women's health needs, from family planning and prenatal testing to hereditary cancer screening.
Panorama
The company launched Panorama, its non-invasive prenatal test, or NIPT, in 2013 and have since gone from being the fourth company to enter the NIPT market to being the market leader by volume in the United States. Panorama helps physicians assess the risk of fetal genetic abnormalities by non-invasively screening for fetal chromosomal abnormalities, including Down syndrome, Edwards syndrome, Patau syndrome, Turner syndrome and triploidy, which often result in intellectual disability, severe organ abnormalities and miscarriage. Panorama also screens for five of the most common genetic diseases caused by microdeletions - 22q11.2 deletion syndrome (DiGeorge syndrome), 1p36 deletion, Angelman syndrome, Cri-du-chat syndrome and Prader-Willi syndrome. Diseases caused by microdeletions are often not detected via common screening techniques such as ultrasound or hormone-based screening, yet the presence of a microdeletion can critically impact postnatal treatment. For example, when learning prior to birth that a newborn has 22q11.2 deletion syndrome, doctors will know to monitor the infant and administer calcium if needed to avoid seizures and permanent cognitive impairment, and will know to avoid administering routine vaccinations due to the immunodeficiency frequently associated with this condition. Unlike Down syndrome, where the risk increases with maternal age, the risk of the five microdeletions that Panorama screens for is independent of maternal age. Based on data published in Prenatal Diagnosis and American Journal of Obstetrics & Gynecology, the combined prevalence of these targeted microdeletions is approximately one in 1,000 pregnancies, which collectively makes them more common than Down syndrome for women approximately 28 years of age or younger. In particular, 22q11.2 is the most common microdeletion; a key finding from the company's SNP-based Microdeletions and Aneuploidy RegisTry (SMART) study described below was a higher-than-expected prevalence of 22q11.2 deletion syndrome of one in 1,524 pregnancies in the study cohort.
Panorama can also identify fetal sex for single birth pregnancies as well as of each fetus in twin pregnancies, and has demonstrated the ability to identify fetal sex more accurately than competing NIPTs. This is partially a result of Panorama's unique ability to detect a vanishing twin, which is a known driver of fetal sex errors with the quantitative methods used by the company's competitors. The American Journal of Obstetrics & Gynecology noted that the ability of Panorama to identify additional fetal haplotypes is expected to result in fewer false positive calls and prevent incorrect fetal sex calls compared to other methods.
Panorama demonstrates the capabilities of the company's technology by employing the company's fundamentally unique approach of simultaneously measuring thousands of SNPs in a single test reaction to identify genetic variations in fetal DNA with a high degree of specificity and sensitivity, which can give patients and their physicians a greater degree of comfort in choosing to forego unnecessary invasive procedures, limiting the resulting risk of spontaneous miscarriage associated with invasive procedures and lowering the total cost to the healthcare system of these procedures. Furthermore, with recent technological advances validated in the SMART study, Panorama leverages artificial intelligence to enable highly accurate results on samples for which a result would otherwise be difficult to determine. Panorama screens for common genetic conditions that affect both high-risk pregnancies, where maternal age is 35 years or older and which the company estimates represent approximately 800,000 of the approximately 4.3 million pregnancies in the United States, and average-risk pregnancies, which the company estimates represent approximately 3.5 million pregnancies in the United States.
Panorama is performed on a maternal blood sample and can be performed as early as nine weeks into a pregnancy, which is significantly earlier than traditional methods, such as serum protein measurement whereby doctors measure the presence and amount of certain hormones in the blood. Panorama starts with a simple blood draw from the mother, either in a doctor's office, in a laboratory or through a phlebotomist that travels to the patient, and the sample is sent to one of the company's CLIA-certified and CAP-accredited laboratories for processing. After Panorama generates its result, the company provides the doctor or the laboratory with a report showing whether there is a high risk or low risk that abnormalities are present in the fetus.
The analytic and clinical validity of the company's technology demonstrated in NIPT has been described in more peer-reviewed publications covering more patients than the company's competitors. The SMART study, published in the American Journal of Obstetrics and Gynecology, evaluated the performance of cfDNA screening for aneuploidies T21, T18 and T13, as well as for 22q11.2 by tracking birth outcomes in the general population among women who presented clinically and elected Panorama microdeletions and aneuploidy screening as part of their routine care. Over 17,000 aneuploidy cases and over 18,000 22q11.2 deletion syndrome cases were analyzed. In particular, Panorama demonstrated sensitivity of approximately 99%, specificity of over 99.9%, and a PPV of 95% for T21 in the SMART study. Based on a publication in the Journal of Clinical Medicine, Panorama has demonstrated greater than 99% overall sensitivity and greater than 99.9% overall specificity for T21, T18 and T13. Furthermore, a paper published in Obstetrics & Gynecology reported that Panorama had a statistically significant lower false positive rate than other NIPT methods practiced by the company's U.S. competitors. In the SMART study, Panorama demonstrated sensitivity for 22q11.2 deletion syndrome of 83%, clinical PPV of approximately 53%, and a false positive rate of 0.05% using the company's updated artificial intelligence algorithm.
Panorama is also the only commercially available NIPT for twin pregnancies that can distinguish between each twin's DNA, and therefore can determine zygosity, or whether the twins are identical or fraternal, and the fetal sex of each twin. Determining zygosity early in a pregnancy can help guide the management of a pregnancy, as certain monozygotic, or identical twin, pregnancies are at higher risk for various complications such as twin-twin transfusion syndrome, where there is an unequal sharing of blood, and therefore unequal growth, between the twins. Panorama screens twin pregnancies for Down, Edwards and Patau syndromes and, for identical twins, Turner syndrome and 22q11.2 deletion syndrome, among others. In validation studies, Panorama identified identical twins with over 99% sensitivity and specificity and achieved a combined sensitivity of over 99% and specificity of over 99% for Down, Edwards and Patau syndromes in twin pregnancies.
Horizon
The company's Horizon carrier screening test helps individuals and couples determine if they are carriers of genetic variations that cause certain genetic conditions. Depending on the condition, if one or both parents are carriers, it could result in a child affected with the condition. Many people do not know they are a carrier for an inherited genetic condition until they have an affected child. These conditions are often rare and usually there is no family history, and although certain conditions are more common in certain ethnic groups, ethnicity may not be a reliable predictor of carrier status, as patients are increasingly of mixed or uncertain ethnicities. The industry's approach to carrier screening has accordingly evolved over time, from screening targeting specific ethnicities with a higher incidence of screened conditions, to pan-ethnic screening for certain conditions based on incidence and clinical utility, and most recently to expanded screening for many conditions simultaneously.
Horizon was created based on recommended screening guidelines from ACOG, ACMG, and the Victor Center for the Prevention of Jewish Genetic Diseases. Horizon screens for up to 445 inherited conditions across a selection of screening panels, including Cystic Fibrosis, Duchenne Muscular Dystrophy, or DMD, Spinal Muscular Atrophy, Fragile X Syndrome and other conditions, and performs with a 99% detection rate for most conditions.
The sample required for Horizon can be obtained simultaneously with the sample required for Panorama, which makes it easier for the company to offer, and for patients to take, both tests. Horizon employs various methodologies to analyze the DNA from the individual's blood or saliva sample to determine if the individual is a carrier for the genetic conditions being screened. These methodologies include next generation sequencing to detect single nucleotide variants, insertions and deletions, and copy number changes, and PCR fragment analysis to detect certain genetic variants.
Other Women's Health Products
While Panorama and Horizon represent the significant majority of the company's women's health revenues, the company offers a portfolio of tests addressing reproductive and women's health. The company's Vistara single-gene NIPT screens for 25 single-gene disorders that cause severe skeletal, cardiac and neurological conditions which affect quality of life, are often associated with cognitive disabilities and could benefit from medical and/or surgical intervention. The conditions screened by Vistara have a combined incidence of approximately 1 in 600, which is higher than that of Down syndrome as well as Cystic Fibrosis; however, these conditions may otherwise go undetected until after birth or into childhood as traditional NIPTs do not screen for these conditions, prenatal ultrasound findings are not a reliable indicator, and family history is not a good indicator of risk for these conditions, which are commonly caused by new, and not inherited, mutations. Screening for these conditions early in a pregnancy can facilitate early diagnosis, enable patients to be referred to MFMs and other specialists for targeted evaluations, to guide labor and delivery management, and to allow families to mobilize resources, ask questions and anticipate future needs. The company has received a CE Mark for Vistara from the European Commission. In validation studies, Vistara demonstrated a combined analytical sensitivity and analytical specificity of greater than 99%.
Spectrum, the company's preimplantation genetic test for couples undergoing IVF, can improve the chance of a successful pregnancy while reducing the chance of miscarriage or of having a child with a chromosomal condition, by helping to identify the healthiest embryos during an IVF cycle. In particular, aneuploidy is common in human embryos-particularly as women age-and is the primary cause of failed IVF. In a study published in April 2018, a retrospective analysis of pregnancy outcomes demonstrated that use of Spectrum during IVF led to increased rates of implantation, clinical pregnancy, and live births. Spectrum incorporates the company's proprietary technology to confirm parentage, determine the parental origin of the chromosomal abnormality, and further screen for uniparental disomy, in which two copies of a chromosome come from the same parent.
Anora, the company's products of conception, or POC, test, analyzes miscarriage tissue from women who have experienced one or more pregnancy losses to determine whether there was an underlying chromosomal reason for the loss. Anora can detect trisomy, triploidy, extra or missing chromosome pieces, and uniparental disomy. The Anora test is helpful to obstetricians, gynecologists and IVF physicians in supporting their patients' reproductive goals. Anora can help couples understand the likelihood of another miscarriage, their future reproductive options, and whether there are any steps that could help them avoid a miscarriage in future pregnancies.
Empower, the company's hereditary cancer screening test, screens for over 80 genes associated with increased risk for certain common hereditary cancers, such as breast, ovarian, endometrial, and colorectal cancers. Information from the test can lead to earlier detection of cancer, identify cancer risk-reducing strategies, inform surgical and therapeutic decisions following a cancer diagnosis, and provide an opportunity to notify family members who may be at similar risk for hereditary cancer.
The company's non-invasive prenatal paternity product allows a couple to safely establish paternity without waiting for the child to be born. Testing can be done as early as nine weeks of gestation using a blood draw from the pregnant mother and alleged father. The company's internal data indicates that the accuracy of this test is greater than 99.99%. The company has licensed this technology to a third party to perform the test in its clinical laboratory.
Oncology
In oncology, the company has been initially focused on detecting molecular residual disease, which the company refers to as MRD, and recurrence monitoring in solid tumors, where the company has generated data in over a dozen different cancer types and have published data in, among others, colorectal, bladder, breast, and lung cancer, as well as multiple myeloma and other tumor types. Molecular residual disease is the presence of small traces of cancer in the blood, such as ctDNA or microscopic pieces of tumor DNA that are often undetectable with standard imaging techniques. If left untreated, residual cancer cells can multiply and cause recurrence. MRD testing and molecular monitoring offers the potential for physicians to change or escalate treatment in patients who are MRD-positive, and to de-escalate or avoid unnecessary treatment in patients who are MRD-negative. It also holds potential as a surrogate endpoint in clinical trials.
Signatera
Signatera is the company's personalized ctDNA blood test for MRD assessment, surveillance of disease recurrence, and evaluation of treatment response in patients previously diagnosed with cancer. Each patient receives a custom assay that tracks the presence of 16 tumor-specific clonal mutations that are selected based on the unique mutational signature found in that patient's tumor tissue, which is intended to maximize accuracy for detecting the presence or absence of residual disease in a blood sample, even at variant allele frequency, or VAF, of mutations as low as 0.01% in the blood. This tumor-informed approach is optimal in the MRD setting, in which it is common for tumor DNA to be present only at low frequencies immediately after treatment. Unlike static liquid biopsy panels (also known as therapy selection) or comprehensive genomic profiling, or CGP, which screen for a generic set of mutations independent of an individual's tumor, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and assess how much cancer is left in the body (offering both a qualitative and quantitative measurement), detect recurrence earlier, and help optimize treatment decisions. Signatera can detect residual disease earlier than clinical or radiological recurrence in patients with solid tumors who have received treatment.
The company offers Signatera for research use only to cancer researchers and biopharmaceutical companies. The company also offers Signatera commercially for clinical use as an LDT in the company's own CLIA-certified and CAP-accredited laboratory. Signatera is covered by Medicare for use in patients with certain forms of colorectal cancer, muscle invasive bladder cancer, and adjuvant and recurrence monitoring in advanced breast cancer. The company has also received a final Medicare local coverage determination, or LCD, for the use of Signatera in immunotherapy response monitoring for all tumor types in any patient for whom immunotherapy is indicated. Signatera is also covered under the coverage policies of certain commercial third-party payers, including a pan-cancer coverage policy for adjuvant, recurrence monitoring and treatment monitoring for solid tumors. In addition, Signatera has been granted Breakthrough Device Designations by the FDA covering its use in various applications.
Signatera has been shown in various clinical studies - including close to 60 peer-reviewed publications as of February 1, 2024 - to identify MRD significantly earlier than standard diagnostic tools, and that Signatera test status is a significant indicator of long-term patient outcomes after surgery and treatment, relative to other clinical and pathological factors. In particular, the company has demonstrated in studies across multiple tumor types, including colon, breast, lung and bladder, that a positive Signatera test result, without further treatment, has predicted relapse with an overall PPV of over 98%. Furthermore, a study published in Clinical Cancer Research demonstrated the ability of Signatera to assess the rate of change in quantity over time, or velocity, of ctDNA in early-stage colorectal cancer patients, providing additional information that may be used to predict patient survival and outcomes, further stratify MRD-positive patients, and inform disease management. The company is continuing to generate data, building evidence of the clinical validity and utility of the test across multiple cancer types and in collaboration with leading universities and cancer centers, NIH's National Cancer Institute, or NCI, non-profit cancer research groups, and pharmaceutical companies.
Altera
Altera is the company's tissue based comprehensive genomic profiling test that provides insight into genomic alterations and biomarkers found in a patient's tumor, supporting treatment decisions and therapy selection by prioritizing potentially beneficial therapies based on the patient's tumor biomarkers and cancer type. Based on the company's internal estimates, therapy selection represents an approximate $6.0 billion market opportunity. Altera can be ordered as a stand-alone test, as well as in conjunction with the company's Signatera MRD test to combine therapy selection with ongoing monitoring.
Empower
The company offers Empower, the company's hereditary cancer test, to oncologists, in addition to physicians through the company's women's health commercial channel. Because Empower screens for genetic mutations in genes that are associated with increased risk of certain hereditary cancers, information from the test can help determine if a patient who has been diagnosed with such a cancer is a carrier of a mutation associated with their cancer. This can inform surgical and therapeutic decisions, as well as provide an opportunity to notify family members who may be at similar risk for hereditary cancer.
Organ Health
Prospera
The company's Prospera test is used to assess active rejection in patients who have undergone kidney, heart, or lung transplantation by measuring the fraction and quantity of dd-cfDNA in the recipient's blood, which can spike relative to background cfDNA when the transplanted organ is injured due to immune rejection. The current tools for assessing organ transplant rejection are either invasive (biopsies) or inaccurate (serum creatinine for kidney transplants, for example), resulting in an unmet need for better diagnostic tools to monitor for allograft rejection and improve patient management and outcomes. Many patients are still subjected to unnecessary biopsies, while other patients remain undiagnosed in the case of subclinical rejection, which can increase the risk of graft failure. The company's Prospera test is designed for use by physicians to help rule in or rule out active rejection when evaluating the need for diagnostic testing or the results of an invasive biopsy, and thereby potentially lowering the overall costs associated with transplant care and improving graft survival.
The company's Prospera Kidney test is designed to give physicians a comprehensive view of a patient's rejection status. The company's clinical validation study for Prospera Kidney, conducted in collaboration with the University of California, San Francisco, a recognized leader in transplantation care, and published in the Journal of Clinical Medicine, demonstrated 89% sensitivity in detecting active rejection, with specificity of 73%, based on a cutoff of 1% dd-cfDNA. The assay performed particularly well in detecting T-cell mediated rejection, or TCMR, and subclinical rejection, both of which are areas of unmet need. The company's Prospera Kidney test has also demonstrated excellent performance in an analytical validation study that included donor-recipient pairs that were related, such as parents or siblings. Related-donor cases are challenging because it is technically difficult to differentiate between DNA patterns of close relatives; however, the company was able to achieve a high degree of accuracy by leveraging the company's experience with SNP-based methods in the reproductive health setting.
This is promising for the estimated 52% of live kidney donations that are from a biological relative of the patient. The Prospera Kidney test is covered by Medicare for all kidney transplant recipients, including those with multiple kidney transplants.
A significant number of heart transplant patients experience acute rejection in their first year - over 31% of recipients aged 18 to 34, and over 18% of recipients aged 65 or older, who received a transplant in 2020 experienced acute rejection in their first year. The company's Prospera Heart test assesses acute rejection, exhibiting sensitivity and specificity of 79% and 77%, respectively, as well as an overall AUC of 0.86, in the company's clinical validation study published in the Journal of Heart and Lung Transplantation. The Prospera Heart test is covered by Medicare for heart transplant patients.
Lung transplantation has a five-year survival rate of approximately 60%, and chronic lung allograft dysfunction, or CLAD, is a leading cause of death beyond the first year, affecting close to 50% of recipients by five years post-transplant. Because there are no known effective therapies for CLAD, a critical part of post-transplant management is identifying, avoiding, and treating known risk factors for CLAD, in particular acute rejection. The company's Prospera Lung test exhibited strong performance in the company's clinical validation study, published in Transplant Direct, distinguishing antibody mediated and acute cellular rejection from stable patients with an AUC of 0.91, as well as distinguishing organ injury - including acute rejection, chronic rejection and infection (which can be more challenging) - from stable patients with an AUC of 0.76. The test is covered by Medicare for use in the surveillance setting for lung transplant patients.
As with oncology, the company is continuing to generate data in multiple clinical studies designed to demonstrate clinical utility and other benefits of the company's Prospera test.
Renasight
Renasight is the company's kidney gene panel test to determine if there may be a genetic cause for an individual's CKD, or increased hereditary risk for kidney disease due to family history. The test uses a blood or saliva sample to test over 380 genes associated with CKD, ranging from common inherited kidney disorders to more rare conditions. Results from the company's Renasight test may provide valuable information to help manage CKD in a patient, such as identifying the cause of the disease and helping to predict its progression, informing more tailored interventions and treatments, or providing information to family members who may also be at risk for kidney disease.
The company has published initial results from the company's Renasight Clinical Application, Review, and Evaluation (RenaCARE) study assessing the frequency and impact of genetic testing within the CKD population. Over 20% of patients in the study had a positive genetic finding, half of whom received a new or reclassified diagnosis and one-third of whom had a change in treatment plan.
Constellation
The company's Constellation software forms the core of the company's cloud-based distribution model. Through this model, the company has been able to expand access to the company's molecular and bioinformatics capabilities worldwide, enabling laboratories, under a license from the company, to run the molecular workflows themselves and then access the company's computation-intensive bioinformatics algorithms through Constellation, which runs in the cloud, to analyze the results. The company has licensing contracts with various laboratories in the United States and internationally who are using the company's Constellation platform commercially in NIPT and in prenatal paternity testing, and the company may expand this distribution model to other products in the future. The company also leverages Constellation to perform the company's internal commercial laboratory activities and research and development of the company's products.
The company has received CE Marks from the European Commission for the company's Constellation software and for the key reagents that the company's laboratory licensees use to run their NIPT test prior to accessing the company's Constellation software. These CE Marks enable the company to offer Constellation in the European Union and other countries that accept a CE Mark. The company is pursuing other regulatory approvals, as needed, to allow the international roll out of Constellation in regions that do not accept a CE Mark.
Commercial Capabilities
The company has established a broad distribution channel, comprising the company's direct sales efforts, as well as a worldwide network of over 100 laboratory and distribution partners. The company's own direct sales force and managed care teams anchor the company's commercial engagement with physicians, laboratory partners, and payers, and sell directly to MFMs, OB/GYNs, physicians or physician practices, IVF centers, transplant centers, or integrated health systems. The company strives to offer an excellent customer and patient experience through the company's field sales reps, medical science liaisons and medical affairs personnel, and the company's customer service and mobile phlebotomy offerings.
In addition to the company's sales force, the company markets to physicians through channels and media, such as clinical journals, educational webinars, at conferences and tradeshows, and through e-mail and social media marketing campaigns. While the company does not sell directly to patients, the company does engage in brand awareness campaigns directed at patients to highlight the company's products. The company's marketing and medical science liaison teams work extensively with key opinion leaders in the women's health, oncology and organ health fields.
The company's partners' capabilities augment its direct sales capabilities, and where the company has identified laboratory or distribution partners who share the company's focus on premium quality and service, the company also contracts with them to distribute the company's tests. In NIPT, the company has partnered with leading academic and commercial laboratories and hospital systems in the United States given their relationships with MFMs and OB/GYNs, large distribution capabilities, and commercial infrastructure. These distribution partners also frequently have in-network contracts with key third-party payers. Outside of the United States, where the company's products are sold in over 80 countries, the company sells predominantly through partner laboratories.
Enhanced User Experience
NateraCore is the company's suite of resources designed to enhance the patient and provider experience. Through this platform, the company provides patient and provider educational materials, information about insurance coverage and test costs, test and phlebotomy, or blood draw, ordering capabilities, test results reporting, and next steps, in each case as applicable to a particular patient or test. These resources make available a completely remote testing option for patients, fulfilled through the company's online tools combined with a nationwide mobile phlebotomy network whereby a patient can request and schedule a phlebotomist visit at the patient's home or office. This capability proved to be especially important during the COVID-19 pandemic, enabling continuity of care for all patients despite pandemic-related restrictions and shutdowns, and particularly for those who may be immunocompromised or immune-suppressed.
The company has also created provider portals that enable physicians to easily complete various tasks online such as electronic ordering and tracking tests, managing patient consents and results, accessing billing and other documentation, connecting with genetic counselors and other support, and ordering supplies and educational materials. The company also provides a service to integrate with the company's customers' Electronic Medical Records, or EMR, systems to provide physicians a seamless experience of ordering tests and reviewing patient test results directly through their EMR systems.
The company has an internal team of board-certified genetic counselors to support patients with pre- and post-test genetic information sessions, and physicians should they have any questions or require any support in interpreting the results.
In addition to the company's mobile phlebotomy service, the company has a network of over 2,000 phlebotomy centers across the United States.
Competition
The company's competitors in the NIPT space include Laboratory Corporation of America Holdings, or LabCorp; Myriad Genetics, Inc.; Quest Diagnostics Incorporated, or Quest; Illumina, through its subsidiary Verinata; BillionToOne Inc.; BGI; BioReference Health, LLC, a subsidiary of OPKO Health, Inc.; PerkinElmer Inc.; and Ambry Genetics, a subsidiary of Konica Minolta. The company also competes against companies providing carrier screening tests such as LabCorp; Myriad Genetics, Inc.; Fulgent Genetics; BillionToOne Inc.; Quest; Ambry Genetics; and GenPath Diagnostics, a division of BioReference Health, LLC.
In the field of oncology, the company competes with various companies that offer or seek to offer competing solutions, such as NeoGenomics, Inc.; Invitae Corp., which acquired ArcherDX, Inc. and which was one of the company's primary competitors in both NIPT and carrier screening prior to the company's acquisition in January 2024 of certain of Invitae's reproductive health assets related to its NIPT and carrier screening business; Guardant Health, Inc.; Tempus Labs, Inc.; Personalis, Inc.; Exact Sciences Corp.; and Quest.
In organ health, the company's primary competitor is CareDx, Inc.
Intellectual Property
As of December 31, 2023, the company held approximately 170 issued U.S. and foreign patents, which expire between November 2026 and November 2044, and approximately 250 pending U.S. and foreign patent applications.
Government Regulations
The company's business is subject to and impacted by extensive and frequently changing laws and regulations in the United States (at both the federal and state levels) and internationally. Some of these laws and regulations are particular to its laboratory business while others relate to conducting business generally (e.g., export controls laws, the U.S. Foreign Corrupt Practices Act and similar laws of other jurisdictions). The company is also subject to inspections, audits and other inquiries by certain federal and state governmental agencies.
The company's laboratories have each also been accredited by the College of American Pathologists, or CAP, which means that its laboratories have been certified as following CAP standards and guidelines in operating the laboratory facility and in performing tests that ensure the quality of its test results.
In addition to federal certification requirements for laboratories under CLIA, it is required under California law to maintain a California state license for both its San Carlos, California and Austin, Texas clinical laboratories, and to comply with California state laboratory laws and regulations, because its San Carlos facility is located in, and both facilities test specimens originating from, California. Similar to the federal Clinical Laboratory Improvement Amendments (CLIA) regulations, the California state laboratory laws and regulations establish standards for the operation of a clinical laboratory and performance of test services, including the education and experience requirements of the laboratory director and personnel (including requirements for documentation of competency), equipment validations, and quality management practices. Because the company tests specimens in both its Austin, Texas and San Carlos, California laboratories originating from, and return test results to, New York State, both of its laboratories are required to obtain a New York state laboratory permit and comply with New York state laboratory laws and regulations.
The company's clinical laboratories are subject to proficiency testing and on-site survey inspections conducted by the Clinical Laboratory Evaluation Program, or CLEP, under the New York State Department of Health (DOH). Each of the company's Austin and San Carlos clinical laboratories has received approval from New York's CLEP to offer its tests that are performed in those locations.
The company is required to comply with Health Insurance Portability and Accountability Act of 1996 (HIPAA) standards promulgated by the U.S. Department of Health and Human Services, or HHS. First, the company must comply with HIPAA's standards for electronic transactions, which establish standards for common healthcare transactions, such as claims information, plan eligibility, payment information and the use of electronic signatures.
The company must also comply with the standards for the privacy of individually identifiable health information, which limit the use and disclosure of most paper and oral communications, as well as those in electronic form, regarding an individual's past, present or future physical or mental health or condition, or relating to the provision of healthcare to the individual or payment for that healthcare, if the individual can or may be identified by such information. Additionally, the company must comply with HIPAA's security standards, which require it to ensure the confidentiality, integrity and availability of all electronic protected health information (PHI) that it creates, receive, maintain or transmit, to protect against reasonably anticipated threats or hazards to the security of such information, and to protect such information from unauthorized use or disclosure.
Because each of the company's laboratories holds a New York the Clinical Laboratory Evaluation Program (CLEP) permit, it must comply with New York state laboratory statutes and regulations, which include anti-kickback provisions, Public Health Law Section 587, and Medicaid anti-kickback provisions, 18 NYCRR Section 515.2, related to laboratory services. Because the company operates a laboratory facility located in Texas, its business arrangements are subject to certain Texas laws.
The company is subject to California's Physician Ownership and Referral Act, or PORA, which generally prohibits it from billing a patient or any governmental or private payer for any laboratory services when the physician ordering the service, or any member of such physician's immediate family, has a 'financial interest' with it, unless the arrangement meets an exception (CA Business and Professions Code Section 650.02).
History
The company was founded in the state of California as Gene Security Network, LLC in 2003 and incorporated in the state of Delaware in 2007. Further, the company changed its name to Natera, Inc. in 2012.
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