Bio-Techne Corporation and its subsidiaries (Bio-Techne) 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...
Bio-Techne Corporation and its subsidiaries (Bio-Techne) 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.
Segments
The company manages the business in two operating segments: Protein Sciences and Diagnostics and Genomics.
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 protein analysis, automated western blot, and multiplexed ELISA workflows.
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 company operates globally, with offices in many locations throughout North America, Europe and Asia. The company’s product lines include hundreds of thousands of diverse products, most of which the company manufactures itself in multiple locations in North America, as well as a location each in the U.K. and China.
From 2013 through 2024, the company has acquired, agreed to acquire, or made investments in twenty companies that have expanded the product offerings and geographic footprint of both operating segments, including the acquisition of Lunaphore SA (‘Lunaphore’) at the beginning of fiscal year 2024. The company also completed a 19.9% investment in Wilson Wolf Corporation (‘Wilson Wolf’) in 2023, and will acquire the remaining ownership in Wilson Wolf by the end of calendar year 2027. Additionally, subsequent to fiscal 2024, the company made an investment in Spear Bio, which is a leader in the development and manufacturing of ultra-sensitive immunoassays capable of measuring protein biomarkers at attomolar level from sub-microliter sample volume.
The company is committed to providing the life sciences community with innovative, high-quality scientific tools that allow the company’s customers to make extraordinary discoveries and treat and diagnose diseases.
The company’s strategic pillars are to grow and leverage the core; capitalize on high potential markets; market expansion through innovation & acquisition; and deliver best-in-class customer experience.
Protein Sciences Segment
Products and Markets
The Protein Sciences segment is the larger of the company’s two segments, representing approximately 72% of the company’s net sales in fiscal 2024. It is consisted of 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 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-based therapies. 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.
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 Diagnostics and Genomics segment includes three divisions and is focused primarily on the diagnostic and research markets 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. In the first quarter of fiscal year 2024, the company closed on the acquisition of Lunaphore, a leading developer of fully automated spatial biology solutions using precision microfluidic technology capable of revealing hyperplex proteomic and transcriptomic biomarkers in tumors and other tissues at single-cell and subcellular resolution. Lunaphore’s COMET instrument automates ACD’s RNAscope assays and utilizies antibodies to enable simultaneous hyperplex detection of protein and RNA biomarkers on the same slide at single-cell resolution.
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 in men with grey-zone prostate specific antigen (PSA) scores. ExoDX Prostate is offered by Exosome Diagnostics as a lab-developed test. The company has also licensed exclusively the ExoTRU kidney transplant rejection test 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.
Diagnostics and Genomics Segment 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
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.
New Products
Bio-Techne is engaged in continuous research and development in all of the company’s major product lines. The company also carries out research to develop new products that build upon and expand the technologies the company acquires through its acquisition strategy. In fiscal 2024, the company introduced over 800 new products.
Intellectual Property
As of June 30, 2024, the company had rights to approximately 710 granted patents and approximately 330 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’). The FDCA requires these products, when sold in the United States, to be safe and effective for their intended uses and to comply with the regulations administered by the U.S. Food and Drug Administration (‘FDA’).
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 the company’s 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.
One of the company’s products under its Exosome Diagnostics brand is offered as a test by a certified laboratory under CLIA. 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 UK Bribery Act and similar anti-bribery laws.
The Health Insurance Portability and Accountability Act of 1996 (‘HIPAA’), which prohibits knowingly and willfully (1) executing, or attempting to execute, a scheme to defraud any health care benefit program, including private payors, or (2) 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.
As a global organization, the company is subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of the company’s business. 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. In particular, a broad privacy law in California, the California Consumer Privacy Act (‘CCPA’), came into effect in January 2020. The CCPA has some of the same features as the GDPR (discussed below) and has already prompted several other states to follow with similar laws. The EU General Data Protection Regulation that became effective in May 2018 (‘GDPR’) has imposed significantly stricter requirements in how the company collects, transmits, processes, and retains 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 Bio-Techne’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 1976.
