About Laboratory Corp of America Holdings

Laboratory Corporation of America Holdings is a global leader of innovative and comprehensive laboratory services that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. By leveraging its unparalleled diagnostics and drug development capabilities, the company provides insights and accelerates innovations to improve health and improve lives. The company serves clients in more than 100 countries. Strategy Through leadership in science, technology and innovation, the company provides vital information and services to help its customers make clear and confident health decisions and helps millions of people improve health and improve lives. The company is expanding its role in the rapidly evolving healthcare market by strengthening its positions across its portfolio of capabilities, growing strategic opportunities that drive new business, and differentiating its unique offerings, capabilities, and financial performance. The company focuses on two near-term strategic opportunities for growth across both Dx and BLS. The key elements of the company's strategy are to be the partner of choice for health systems and local and regional laboratories; to lead in the development, licensing, and scaling of specialty testing including companion diagnostics; establish leadership and partnership capabilities in cell and gene therapy; expand consumer-centric capabilities; and expand global reach, including through companion diagnostics. Segments The company operates through two segments, consisting of Diagnostics Laboratories (Dx), which includes routine testing and specialty/esoteric testing, and Biopharma Laboratory Services (BLS), consisting of Early Development Research Laboratories and Central Laboratory Services. The company worked on 90% of the new drugs approved by the FDA in 2023 and performed more than 600 million tests for patients around the world. Diagnostics Laboratories segment Dx is an independent clinical laboratory business. It offers a comprehensive menu of frequently requested core testing and specialty testing through an integrated network of primary and specialty laboratories across the U.S. and Canada. This network is supported by a sophisticated information technology system, with more than 80,000 electronic interfaces to deliver test results, nimble and efficient logistics, and local labs offering rapid response testing. Dx also provides patient access points that are strategically and conveniently located throughout the U.S., including more than 2,000 patient service centers (PSCs) and more than 6,000 in-office phlebotomists located in customer offices and facilities. Although testing for healthcare purposes and customers who provide healthcare services represents the most significant portion of the clinical laboratory industry, clinical laboratories also perform testing for other purposes and customers, including employment and occupational testing, DNA testing to determine parentage and to assist in immigration eligibility determinations, environmental testing, wellness testing, toxicology testing, pain management testing, and medical drug monitoring. Dx offers an expansive test menu that includes a wide range of clinical, anatomic pathology, genetic and genomic tests, and regularly adds new tests and improves the methodology of existing tests to enhance patient care. Dx also offers more than 50 consumer-initiated wellness testing available online through its Labcorp OnDemand platform. Dx has more than 160 million patient interactions per year, including patients getting lab results, going to the company's websites, and purchasing testing online through Labcorp OnDemand. As part of an ongoing commitment to be an efficient and high-value provider of laboratory services, Dx implemented and has maintained a comprehensive business process improvement initiative known as LaunchPad. The initiative was designed to reengineer the company's systems and processes to create a sustainable and more efficient business model, and to improve the experience of all stakeholders. The Dx business can be categorized into the following components: Testing Operations and Productivity: Includes network of PSCs offering specimen collection services; comprehensive, nimble supply chain for transferring specimens across the entire life cycle of a patient sample; 1-2 day turnaround time for most test results, with the vast majority of results delivered electronically to healthcare providers and to patients who have a Labcorp Patient account; and rigorous standard of quality - 24 regional/specialty labs hold ISO 15189 certification, 3 labs hold ISO 13485 certification, and one lab holds both. Testing and Related Services Standard Testing Services - frequently-ordered tests used in regular patient care include blood chemistry analyses, urinalyses, blood cell counts, thyroid tests, PAP tests, hemoglobin A1C, prostate-specific antigen (PSA), tests for sexually transmitted diseases (e.g., chlamydia, gonorrhea, trichomoniasis and human immunodeficiency (HIV), and hepatitis C (HCV)), vitamin D, microbiology cultures and procedures, and alcohol and other substance abuse tests. Specialty Testing Services - industry leader in gene-based and esoteric testing; advanced tests that target specific diseases and use new technologies; services include anatomic pathology/oncology, cardiovascular disease, coagulation, diagnostic genetics, endocrinology, infectious disease, women's health, pharmacogenetics, parentage and donor testing, occupational testing services, medical drug monitoring services, chronic disease programs, and kidney stone prevention. Dx offers a range of health and wellness services to employers and MCOs, including health fairs, on-site and at-home testing, vaccinations and health screenings. Development of New Tests: Includes more than 130 new tests launched in 2023; active diagnostics and therapeutics research division: approximately 650 studies, articles, and presentations produced in 2023; and continuous investing, internally and externally, in new testing technologies and advanced testing capabilities Technology-Enabled Services and Support: A range of services and support using proprietary technologies to improve the customer and patient experience and provide convenient access to data and analytics, including more than 6.7 million enhanced clinical decision support (CDS) reports delivered to physicians and health systems; online and mobile applications improving the patient experience by allowing patients to learn about the company's services and products, schedule PSC visits, check-in upon PSC arrival, complete documentation, access tests and test results, and manage their accounts; and online applications for providers, MCOs and accountable care organizations (ACOs) to obtain test results and population and health management data. Biopharma Laboratory Services segment BLS provides drug development, medical device and companion diagnostic development solutions from early-stage research to clinical development, along with support for crop protection and chemical testing, through its Early Development Research Laboratories and Central Laboratory Services businesses. Its customers are comprised of pharmaceutical, biotechnology, medical device, and diagnostic companies across the world. With a global network of operations, BLS offers deep expertise in early development and clinical trials in each therapeutic area. BLS had provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, including 77% of those specific to oncology, 68% of those submitted by biotechnology companies, and 96% of those submitted by leading and large pharmaceutical companies. Through its industry-leading central laboratory business, it supports clinical trial activity in approximately 100 countries. Early Development Research Laboratories Lead Optimization: Connects early discovery activities to regulated preclinical studies. Analytical Services: Bioanalytical testing services offering appropriate dose and frequency of drug administration. Safety Assessment: General, genetic, and immunotoxicology services; nonclinical pathology; safety pharmacology services; preclinical medical device services; respiratory services; and developmental and reproductive toxicology (DART) studies. Chemistry Manufacturing Services: Robust solutions in the areas of safety, identity, strength, quality, and purity assessments for biologics. Early Phase Development Solutions: Focused, multidisciplinary teams of experts that craft integrated solutions to identify and develop lead drug candidates and reduce development challenges. Crop Protection and Chemical Testing: Consulting services for chemical manufacturers and other firms engaged in the development of modern crop protection technology. Central Laboratory Services: Includes Clinical laboratory services for individuals participating in clinical studies; provided to biopharmaceutical customers through its global network of central laboratories in the U.S., Europe, and Asia; operates world's largest automated clinical trial sample collection kit production lines that enable kits to be produced with 5.5 sigma precision; and six ISO 15189-certified laboratories. Technology Solutions: Includes proprietary digital tools and services providing customers with greater access to key insights and results, enhanced transparency, quality, and speed of clinical trial patient recruitment; metrics and benchmarking applications for monitoring patient recruitment at clinical site selection, protocol design, and optimization; and ability to communicate with patients in the U.S. who may be eligible for clinical trials. Customers The company provides its services to a broad range of customers across Dx and BLS. The primary customer groups serviced by the company include: Payers - Health Plans and Employers: The company serves many health plans, including MCOs, employer plans, and other health insurance providers, each of which operates on a national, regional, or local basis. In certain locations, health plans may delegate to independent physician associations (IPAs) or other alternative delivery systems (e.g., ACOs) the ability to negotiate for services on behalf of certain members. Pharmaceutical, Biotechnology, Medical Device, and Diagnostics Companies: The company provides services to hundreds of pharmaceutical, biotechnology, medical device, and diagnostics companies, ranging from the world's largest multi-nationals to emerging, small and mid-market companies. Physicians, Large Provider Organizations, and Other Healthcare Providers: Physicians and other healthcare providers who are authorized to order clinical laboratory testing for their patients are a primary source of requests for Dx's testing services. These physicians and other providers may practice in a range of settings, including small medical practices, community-based clinics, and large, multidisciplinary organizations. Hospitals and Health Systems: The company provides hospitals and health systems with services ranging from core and specialty testing to supply chain and technical support services, and the opportunity to be a research partner for participation in studies and clinical trials with BLS. In some cases, a hospital's on-site laboratory may be operated or managed by an outside contractor or independent laboratory, including the company. Other Customers: The company serves a broad range of other customers, including, but not limited to, governmental agencies, employers, patients and consumers, contract research organizations (CROs), crop protection and chemical companies, academic institutions, independent clinical laboratories, and retailers. Sales, Marketing, and Customer Service The company offers its services through a sales force focused on serving the specific needs of customers in different market segments. The company's sales force is responsible for both new sales and for customer retention and relationship building. For Dx, these market segments have different representatives focused on each segment in order to better understand and respond to the unique needs of each segment. These include clinical areas, such as primary care, oncology, women's health, autoimmune diseases, neurology, infectious diseases, endocrinology, gastroenterology, rheumatology and other specialties; payers, such as ACOs, MCOs, and employers; and customers, such as physicians and physician organizations and hospitals and health systems. The BLS global sales organization provides customer coverage across the pharmaceutical, biotechnology, and medical device industries for services including lead optimization, preclinical safety assessment, analytical services, clinical trials, central laboratories, biomarkers, companion diagnostics, and technology solutions. As part of the company's ongoing strategic priority to maximize the value of its unique leadership in both diagnostics and drug development, sales representatives from each business segment work together on outreach to potential customers of both businesses, including hospitals and health systems that may purchase testing and participate in clinical trials, or pharmaceutical, biotechnology, or medical device companies whose studies may benefit from use of Dx's specialty testing, companion diagnostics, and network of PSCs. Seasonality The company experiences seasonality across its business. In 2023, approximately 12.9% of the company's revenues were billed in currencies other than the U.S. dollar, with the Swiss franc, British pound, Canadian dollar, and the euro representing the largest components of its currency exposure. Spin-off of Fortrea Holdings Inc. On June 30, 2023, the company completed the previously announced separation (spin-off) of its former clinical development and commercialization services (CDCS) business, Fortrea Holdings Inc. (Fortrea). Regulation The company's remaining smaller testing sites hold CLIA certificates to perform moderate-complexity testing or a certificate of waiver. Various regulatory agencies, including CMS and the FDA in the U.S., regulate the development, testing, manufacturing, labeling, advertising, marketing, distribution, storage, import, export, performance, and surveillance of diagnostic and therapeutic products and services, including certain products and services offered by the company and the development of therapeutic products that comprise the majority of BLS's business. BLS's laboratory facilities and Dx's clinical laboratory facilities that perform testing services in support of preclinical studies and clinical trials, must conform to a range of standards and regulations, including good laboratory practice (GLP) and good clinical practice (GCP), current good manufacturing practice (cGMP), human subject protection and investigational product exemption regulations, and quality system regulation (QSR) requirements, as applicable. The preclinical and clinical testing intended to support applications for research or marketing, and the studies that the company conducts, are subject to periodic inspections by the FDA, as well as other regulatory agencies in the jurisdictions outside the U.S. in which the company operates, which may include, without limitation, the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., the European Medicines Agency, the National Medical Products Administration in China, and the Pharmaceuticals and Medical Devices Agency in Japan, to determine compliance with GLP, GCP, and cGMP, as well as other applicable standards and regulations. Some Dx products are regulated by the FDA and other similar national regulatory agencies as medical devices. DD complies with licensing and registration requirement standards set by the U.S. Department of Agriculture (USDA) and similar agencies in foreign jurisdictions, such as the European Union, the U.K., and China for the care and use of regulated species. The company is in compliance in all material respects with each of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules. The company has established processes and frameworks to manage compliance with the European Union General Data Protection Regulation (GDPR) and other global privacy and data protection requirements, and to manage preparation for future enacted regulations. The company continues to work through its trade association to address the scope of EKRA. To the extent that the company's laboratories perform such testing, each must be certified as meeting the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services (HHS) (SAMHSA) standards. The company's laboratories in Research Triangle Park, North Carolina; Raritan, New Jersey; Houston, Texas; Southaven, Mississippi; and St. Paul, Minnesota are all SAMHSA certified. History Laboratory Corporation of America Holdings was incorporated in 1994.