Invitae Corporation delivers genetic testing services, digital health solutions and health data services that support a lifetime of patient care and improved outcomes. The company offers genetic testing across multiple clinical areas, including hereditary cancer, precision oncology, women's health, rare diseases and pharmacogenomics. The company applies proprietary design, process automation, robotics and bioinformatics software solutions to expand the use and impact of genetic information and a...
Invitae Corporation delivers genetic testing services, digital health solutions and health data services that support a lifetime of patient care and improved outcomes. The company offers genetic testing across multiple clinical areas, including hereditary cancer, precision oncology, women's health, rare diseases and pharmacogenomics. The company applies proprietary design, process automation, robotics and bioinformatics software solutions to expand the use and impact of genetic information and achieve efficiencies in sample processing and complex variant interpretation, allowing medical interpretation at scale. The company also utilizes digital health solutions to improve ease-of-use and to deliver actionable information about risk, prevention, treatment, and monitoring.
As of December 31, 2022, the company had served over 3.6 million patients, and over 2.2 million of those patients have made their information available for data sharing. The company’s access and scale enables genomic information to speed the discovery and development of new personalized medical therapies — all while making clinical genetic testing and new solutions available to billions of people.
By pioneering new ways of sharing, understanding and applying genetic information, the company is transforming the field of genetics and the application of healthcare data from a series of one-time, one-dimensional queries to a lifelong clinical dialogue with the company’s genes.
The company focuses on making comprehensive, high-quality medical genetic information more accessible and instrumental to the healthcare ecosystem and stakeholders, including patients, healthcare providers, payers, biopharma partners, patient advocacy groups and more. Medical genetics is central to health outcomes and the company is working to bring it to the mainstream by enhancing the customer experience, lowering costs, removing barriers to adoption, and expanding insights and solutions.
As it grows, the company expects that its business will expand and evolve in three stages:
One patient, One Test: The company first launched in November 2013 with an offering of approximately 200 genes, growing the test menu over time to include more than 20,000 genes. In 2022, the company processed billable volume of 1,290,000 units.
One Patient, Multiple Insights: The company utilizes digital health solutions to deliver actionable information about risk, prevention, treatment, and monitoring. With integration, connectivity, and refined go-to-market strategies, the company is shifting to a scenario where each patient test provides many opportunities to deliver solutions — for them, for their families and for others in the ecosystem. The company’s comprehensive portfolio is expected to enable precision medicine, and provides multiple insights for patients as they engage with it across different stages in life and through different health needs. As of December 31, 2022, the company had served over 3.6 million patients, and information from over 2.2 million of those patients is available for data sharing.
Many Patients, Many Solutions: The company focuses its efforts on partnering with these stakeholders to advance the development and utility of its platform. The company’s real-world data is patient-owned and controlled.
In addition to investing in informatics solutions and infrastructure to support its data and patient network development, the company has been expanding its strategic partnerships, which as of December 31, 2022 numbered more than 100 leading biopharmaceutical companies supporting improved patient diagnosis, clinical trial recruitment and other research-related initiatives.
In addition, the company’s biopharmaceutical industry partnerships are complemented by partnerships with leading health systems, executive health programs and leading research institutions, including The Christ Hospital Health Network, the Cleveland Clinic, the Geisinger Health System, the Mayo Clinic, Memorial Sloan Kettering Cancer Center, MedCan, and Stanford Health Care, among others.
Customers
The company receives payment for its products and services from patients, biopharmaceutical partners, third-party payers and other business-to-business customers. As of December 31, 2022, the company’s revenue has been primarily derived from test reports generated from its assays.
Suppliers
The company relies on a limited number of suppliers, or, in some cases, sole suppliers, including Agena Bioscience, Inc.; Illumina, Inc. (Illumina); Integrated DNA Technologies Incorporated; Roche Holdings Ltd.; QIAGEN, Inc.; and Twist Bioscience Corporation for certain laboratory reagents, as well as sequencers and other equipment and materials, which it uses in its laboratory operations.
Seasonality
The company has historically experienced higher revenue in its fourth quarter (year ended December 2022) compared to other quarters in its fiscal year due in part to the seasonal demand of its tests from patients who have met their annual insurance deductible.
Research and Development
The company incurred research and development expenses of $402.1 million in 2022.
Competition
The company’s competitors include companies that offer molecular genetic testing and consulting services, including specialty and reference laboratories that offer traditional single- and multi-gene tests and biopharmaceutical companies. Principal competitors include companies, such as Ambry Genetics Corporation (Ambry Genetics), a subsidiary of Realm IDx, Inc. (Realm IDx); Athena Diagnostics, Inc. (Athena Diagnostics) and Blueprint Genetics, subsidiaries of Quest Diagnostics Incorporated (Quest Diagnostics); Baylor-Miraca Genetics Laboratories LLC (Baylor-Miraca Genetics Laboratories); Caris Life Sciences, Inc. (Caris Life Sciences); Centogene AG; Color Health, Inc. (Color Health); Connective Tissue Gene Test LLC (Connective Tissue Gene Test), a subsidiary of Health Network Laboratories, L.P. (Health Network Laboratories); Cooper Surgical, Inc. (Cooper Surgical); Emory Genetics Laboratory, a subsidiary of Eurofins Scientific; Exact Sciences Corporation (Exact Sciences); Foundation Medicine, Inc. (Foundation Medicine), a subsidiary of Roche Holding AG; Fulgent Genetics, Inc. (Fulgent Genetics); GeneDx Holdings Corp (GeneDx Holdings); Guardant Health, Inc. (Guardant Health); Integrated Genetics, Sequenom Inc. (Sequenom), Correlagen Diagnostics, Inc. (Correlagen Diagnositcs), and MNG Laboratories, subsidiaries of Laboratory Corporation of America Holdings (Labcorp); Myriad Genetics, Inc. (Myriad Genetics); Natera, Inc. (Natera); NeoGenomics, Inc. (NeoGenomics); Perkin Elmer, Inc. (Perkin Elmer); and Tempus Labs, Inc. (Tempus Labs), as well as other commercial and academic laboratories.
Strategy
The company’s strategy for long-term, profitable growth centers on seven key drivers of its business, which work in conjunction to create a flywheel effect extending its leadership position in the new market it is building:
Regulation
Under Clinical Laboratory Improvement Amendments of 1988 (CLIA), the company is required to hold certificates applicable to the type of laboratory examinations it performs and to complies with standards covering personnel, facilities administration, inspections, quality control, quality assurance and proficiency testing.
The company has certifications under CLIA to perform testing at its laboratory locations in San Francisco and Irvine, California, Golden, Colorado, and Iselin, New Jersey. To renew its CLIA certifications, the company is subject to survey and inspection every two years to assess compliance with program standards.
The company is required to comply with the provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) and the regulations implemented thereunder setting forth standards for the privacy of protected health information (PHI); security standards for the protection of electronic PHI; breach notification requirements; and standards for electronic transactions, which establish standards for common healthcare transactions.
In the United States, there are various fraud and abuse laws with which the company must comply, and it is potentially subject to regulation by various federal, state and local authorities, including the Centers for Medicare & Medicaid Services, other divisions of the U.S. Department of Health and Human Services (the Office of Inspector General), the U.S. Department of Justice, and individual U.S. Attorney offices within the Department of Justice, and state and local governments.
History
The company was founded in 2010. It was incorporated in 2010 in the state of Delaware. The company was formerly known as Locus Development, Inc. and changed its name to Invitae Corporation in 2012.
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