Bio-Techne Corp Profile
Bio-Techne Corporation and its subsidiaries develop, manufacture and sell life science reagents, instruments and services for the research, diagnostics and bioprocessing markets worldwide.
With the company’s broad product portfolio and application expertise, the company sells integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases. The company’s products aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. In the year ended June 30, 2023 (fiscal 2023), the company introduced over 1,600 new products.
Strategies
The company’s strategies include continued innovation in core products; market and geographic expansion; culture development; and targeted acquisitions and investments.
Segments
The company manages the business in two operating segments, Protein Sciences; and Diagnostics and Genomics.
Protein Sciences segment
The company’s Protein Sciences segment is a leading developer and manufacturer of high-quality biological reagents used in all aspects of life science research, diagnostics and cell and gene therapy. This segment also includes proteomic analytical tools, both manual and automated, that offer researchers and pharmaceutical manufacturers efficient and streamlined options for automated western blot and multiplexed ELISA workflow.
Products and Markets
The Protein Sciences segment includes two divisions with complementary product offerings serving many of the same customers – the Reagent Solutions division and the Analytical Solutions division.
The Reagent Solutions division consists of specialized proteins, such as cytokines and growth factors, antibodies, small molecules, tissue culture sera and cell selection technologies traditionally used by researchers to further their life science experimental activities and by companies developing next generation diagnostics and therapeutics, including companies developing cell- and gene-based therapeutics.
The company is the world leader in providing high quality proteins, both for research use and under current Good Manufacturing Practices, or cGMP. Key product brands include R&D Systems, Tocris Biosciences and Novus Biologicals. The company’s combined chemical and biological reagents portfolio provides high quality tools that customers can use in solving complex biological pathways and glean knowledge that may lead to a more complete understanding of biological processes, and, ultimately, to the development of novel therapeutic strategies to address different pathologies. In recent years, the company has made several acquisitions and investments that have expanded the company’s product offerings for the cell and gene therapy market. These include a significant investment in state-of-the art facilities for production of both proteins and small molecules in large quantities manufactured in accordance with cGMP, as well as a 19.9% investment in – and eventual acquisition of – Wilson Wolf, which is a leading provider of cell culture devices for cell therapy. Through a collaborative marketing venture with Wilson Wolf and another company, the company has leveraged the products the company has or is developing to provide a more complete offering for the cell and gene therapy market.
The Analytical Solutions division includes manual and automated protein analysis instruments and immunoassays that are used in quantifying proteins in a variety of biological fluids. Products in this division include traditional manual plate-based immunoassays, fully automated multiplex immunoassays on various instrument platforms, and automated western blotting and isoelectric focusing analysis of complex protein samples. Key product brands include R&D Systems and ProteinSimple. A number of the company’s products have been demonstrated to have the potential to serve as predictive biomarkers and therapeutic targets for a variety of human diseases and conditions, including cancer, autoimmunity, diabetes, hypertension, obesity, inflammation, neurological disorders, and kidney failure. Immunoassays can also be useful in clinical diagnostics. In fact, the company has received Food and Drug Administration (FDA) marketing clearance for a few of the company’s immunoassays for use as in vitro diagnostic devices. In addition, in the first quarter of fiscal 2023, the company closed on the acquisition of Namocell, Inc., leading provider of simple single cell sorting and dispensing platforms that are gentle to cells and therefore preserve cell viability and integrity.
Customers and Distribution Methods
The company’s customers for this segment include researchers in academia and industry (chiefly pharmaceutical and biotech companies, as well as contract research organizations). This segment also sells to diagnostic/companion diagnostic and therapeutic customers, especially customers engaged in the development of cell- and gene-based therapies. The company’s biologics line of products in the Analytical Solutions division is used chiefly by production and quality control departments at biotech and pharmaceutical companies. The company sells its products directly to customers who are primarily located in North America, Europe and China, as well as through a distribution agreement with Thermo Fisher Scientific. The company also sells through third party distributors in China, Japan, certain eastern European countries and the rest of the world. The company’s sales are widely distributed.
Diagnostics and Genomics segment
The company’s Diagnostics and Genomics segment develops and manufactures diagnostic products, including controls, calibrators, and diagnostic assays for the regulated diagnostics market, exosome-based molecular diagnostic assays, advanced tissue-based in-situ hybridization assays for spatial genomic and tissue biopsy analysis, and genetic and oncology kits for research and clinical applications.
The Diagnostics and Genomics segment includes three divisions and is focused primarily on the diagnostics market and includes spatial biology, liquid biopsy, molecular diagnostics kits and products, and diagnostics reagents.
Products
The Spatial Biology division products sold under the Advanced Cell Diagnostics, or ACD, brand, are novel in-situ hybridization (ISH) assays for transcriptome, DNA copy, and structural variation analysis within intact cells, providing highly sensitive and specific spatial information at single cell resolution. Since these products preserve spatial context, they are particularly useful for complex tissue profiling.
The Molecular Diagnostics division markets and sells products and services under the Exosome Diagnostics and Asuragen brands. The Exosome Diagnostics brand is based on exosome-based liquid biopsy techniques that analyze genes or their transcripts. It includes the ExoDx Prostate test, which is a urine-based assay for early detection of high-grade prostate cancer used as an aid in deciding the need for biopsy and offered by Exosome Diagnostics as a lab-developed test, as well as the ExoTRU kidney transplant rejection test, which the company has licensed exclusively to Thermo Fisher Scientific. The company also sells products for genetic carrier screening, oncology diagnostics, molecular controls, and research under the Asuragen brand.
The Diagnostic Reagents division consists of regulated products traditionally used as calibrators and controls in the clinical setting. Also included are instrument and process control products for hematology, blood chemistry, blood gases, coagulation controls and reagents used in various diagnostic applications. The company often manufactures these reagents on a custom basis, tailored to a customer’s specific diagnostic assay technology. The company supplies these reagents in various formats, including liquid, frozen, or in lyophilized form. Most of these products are sold on an original equipment manufacturer (OEM) basis to instrument manufacturers, with most products being FDA-cleared.
Customers and Distribution Methods
The customers for the Spatial Biology division include researchers in academia, as well as investigators in pharmaceutical and biotech companies. The company sells its products directly to those customers who are primarily located in North America, Europe, and China; and through distributors elsewhere. In addition to being useful research tools, the company’s DNA and RNA in situ hybridization (ISH) assays have diagnostics applications as well, and several are cleared or under review by the FDA in partnership with diagnostics instrument manufacturers and pharmaceutical companies.
In the United States, the company offers the ExosomeDx Prostate test to physicians using the company’s lab-developed non-invasive urine-based assay for prostate cancer detection. The company’s diagnostic laboratory is certified under and regulated by the State of Massachusetts pursuant to the Clinical Laboratory Improvement Amendments, or CLIA. The company reaches its customers through physicians prescribing such tests for their patients. This test is also available in Europe as a CE-marked product. The Asuragen-branded products are sold primarily to laboratories for use in lab-developed tests or in kit form as regulated diagnostic tests.
The majority of Diagnostic Reagents Division’s sales are through OEM agreements, but the company sells some of its diagnostic reagent products directly to customers and, in Europe and Asia, also through distributors.
Seasonality of Business
Bio-Techne believes there is some seasonality as a result of vacation and academic schedules of its worldwide customer base, particularly for the Protein Sciences segment. There is also some seasonality for the ExosomeDx Prostate test, as patients tend to avoid scheduling medical appointments during the summer and other holidays. A majority of Diagnostics Reagents division products are manufactured in large bulk lots and sold on a schedule set by the customer.
Intellectual Property
As of June 30, 2023, the company had rights to approximately 490 granted patents and approximately 290 pending patent applications. Products in the Analytical Solutions and the Spatial Biology divisions are protected primarily through pending patent applications and issued patents.
Laws and Regulations
A number of the company’s products are classified as medical devices and are subject to restrictions under domestic and foreign laws, rules, regulations, self-regulatory codes and orders, including but not limited to the U.S. Food, Drug and Cosmetic Act (the ‘FDCA’).
Any medical devices the company manufactures and distributes are subject to pervasive and continuing regulation by the FDA and certain state and non-U.S. agencies. As a medical device manufacturer, the company’s manufacturing facilities are subject to inspection on a routine basis by the FDA. The company is required to adhere to the Current Good Manufacturing Practices (‘cGMP’) requirements, as set forth in the Quality Systems Regulation (‘QSR’), which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.
The company must also comply with post-market surveillance regulations, including medical device reporting (‘MDR’) requirements, which require that the company reviews and reports to the FDA any incident in which its products may have caused or contributed to a death or serious injury.
In the European Union (‘EU’), the company’s products are subject to the medical device laws of the various member states, which are based on a Directive of the European Commission. Additionally, the EU has adopted the In Vitro Diagnostic Regulation (the ‘EU IVDR’), which imposes stricter requirements for the marketing and sale of in vitro diagnostic medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.
One of the company’s products under its Exosome Diagnostics brand is offered as a test by a certified laboratory under CLIA (the Clinical Laboratory Improvement Amendments). The company’s Asuragen business also maintains a CLIA certification. Consequently, the company must comply with state licensing regulations applicable to laboratories regulated under CLIA, governing laboratory practices and procedures.
Several of the products sold in the company’s Diagnostics and Genomics segment are subject to various health care related laws regulating fraud and abuse, research and development, pricing and sales and marketing practices, and the privacy and security of health information, including among others:
The U.S. federal regulations regarding quality and cost by the U.S. Department of Health and Human Services (‘HHS’), including the Centers for Medicare & Medicaid Services (‘CMS’), as well as comparable state and non-U.S. agencies responsible for reimbursement and regulation of healthcare goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare fraud.
The U.S. Federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback or bribe), directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made in whole or in part under a federal health care program, such as Medicare or Medicaid.
Comparable laws and regulations similar to, and in some cases more stringent than, the U.S. federal regulations discussed above and below, including the U.K. Bribery Act and similar anti-bribery laws.
The Health Insurance Portability and Accountability Act of 1996 (‘HIPAA’), which prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program, including private payors, or falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services. In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, also restricts the use and disclosure of patient identifiable health information, mandates the adoption of standards relating to the privacy and security of patient identifiable health information and requires the reporting of certain security breaches with respect to such information.
The False Claims Act, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program, knowingly makes, uses or causes to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government.
The Open Payments Act requires manufacturers of medical devices covered under Medicare to, in certain circumstances, record payments and other transfers of value to a broad range of healthcare providers and teaching hospitals and to report this data, as well as ownership and investment interests held by the physicians described above and their immediate family members to HHS for subsequent public disclosure, as well as similar reporting requirements in some states and in other countries.
In addition to the U.S. HIPAA privacy and security rules mentioned above, which impact some parts of the company’s business, individual states also regulate data breach and security requirements, and multiple governmental bodies assert authority over aspects of the protection of personal privacy.
The EU General Data Protection Regulation that became effective in May 2018 (‘GDPR’) has imposed significantly stricter requirements in how the company collect, transmit, process, and retain personal data, including among other things, in certain circumstances a requirement for almost immediate notice of data breaches to supervisory authorities and prompt notice to data subjects with significant fines for non-compliance.
The company is subject to the U.S. Foreign Corrupt Practices Act and various other similar anti-corruption and anti-bribery acts, which are particularly relevant to the company’s operations in countries where the customers are government entities or are controlled by government officials. Both directly and indirectly through the company’s distributors, the company must comply with such laws when interacting with those entities.
As the company’s businesses also include export and import activities, the company is subject to pertinent laws enforced by the U.S. Departments of Commerce, State and Treasury.
History
Bio-Techne Corporation was founded in 1976. The company was incorporated in 1981.
