Meridian Bioscience Profile
Meridian Bioscience, Inc. is a fully-integrated life science company with principal businesses in the development, manufacture, sale and distribution of diagnostic testing systems and kits, primarily for certain gastrointestinal and respiratory infectious diseases, and elevated blood lead levels; and the manufacture and distribution of bulk antigens, antibodies, immunoassay blocking reagents, specialized Polymerase Chain Reaction (PCR) master mixes, and bioresearch reagents used by other diagnostic test manufacturers and researchers in immunological and molecular tests for human, animal, plant and environmental applications.
Segments
The company operates through Diagnostics and Life Science segments.
Diagnostics segment
Products and Markets
The company’s clinical diagnostic products provide accuracy, simplicity and speed; enable early diagnosis and treatment of acute medical conditions; and provide for better patient outcomes. The company targets diagnostics for disease states that are conditions where rapid diagnosis impacts patient outcomes; has opportunistic demographic and disease profiles; are underserved by current diagnostic products; and/or has difficult sample handling requirements (e.g., stool). This approach has allowed the company to establish meaningful market share in its target disease states, gastrointestinal and respiratory illnesses, and tests for elevated lead levels in blood.
The company’s product portfolio includes just under 200 diagnostic tests and transport media, and is marketed to acute care hospitals, reference laboratories, outpatient clinics and physician office laboratories in over 70 countries around the world. The company’s testing platforms include Real-time PCR Amplification (Revogene brand); Isothermal DNA Amplification (Alethia brand); Lateral Flow Immunoassay using fluorescent chemistry (Curian brand); Rapid Immunoassay (ImmunoCard and ImmunoCard STAT! brands); Enzyme-linked Immunoassay (PREMIER brand); Anodic Stripping Voltammetry (LeadCare brands); and urea breath testing for H. pylori (BreathID and BreathTek brands).
The company’s diagnostic assay research and development programs are focused on menu expansion for its Curian and Revogene instrument platforms, with disease targets in the gastrointestinal and respiratory areas, as well as next generation blood-chemistry testing. Pending clearance at the U.S. Food and Drug Administration (FDA) is a 510(k) application for the company’s Curian EHEC Shiga Toxin assay. The company’s new product development pipeline includes gastrointestinal and respiratory multi-plex assays on its Revogene instrument platform, and EHEC Shiga Toxin and C. difficile combo common antigen and Toxins A and B on its Curian instrument platform. In addition, the company has other assays on both platforms moving through its upstream marketing assessment processes that are expected to add to the development pipeline. For the company’s BreathID platform, it is actively looking at the feasibility of combining Urea and Citrica into a single sachet or pouch. The company is also pursuing opportunities to complement its internal research and development programs by securing rights to finished diagnostics tests that it can immediately commercialize.
The April 2020 acquisition of Exalenz Bioscience Ltd. (Exalenz) and the BreathID system, along with the July 2021 acquisition of the BreathTek business, strengthened the company’s position in H. pylori testing, as these products provide an alternative testing approach versus stool antigen testing.
Sales, Marketing and Distribution
The company’s Diagnostics segment relies on direct sales personnel and independent distribution networks. The company has a direct sales force in four countries, covering the United States (U.S.) and certain major markets in the EMEA region (i.e., in Europe, the Middle East and Africa). The company also uses independent distributors either in a complementary manner with its direct sales force (e.g., the U.S.) or solely to supply its products to end-users. The company has two independent distribution customers and a reference laboratory customer that together included 29% of Diagnostics segment net revenues in the year ended September 30, 2022, with each contributing between 8% and 11% of the Diagnostics segment’s net revenues.
Competition
The company’s major competitors in molecular diagnostics are Cepheid (a Danaher business) and Becton Dickinson, both of which have systems with multiple-assay menus. The company also faces competition in molecular diagnostics, but to a lesser degree, from companies, such as Abbott and Quidel Corporation.
The company’s major competitors in rapid immunoassay diagnostics are primarily Abbott and Quidel Corporation. For blood lead testing, the company has the only FDA-cleared, CLIA-waived point-of-care test available commercially. Other blood lead testing systems in use, marketed by the company’s competitors, include Graphite Furnace Atomic Absorption Spectroscopy, which requires a highly skilled technician and larger laboratory space to operate, in addition to not being portable or suitable for point-of-care use.
Intellectual Property, Patents and Licenses
The company owns or licenses the U.S. and foreign patents, most of which are for select products manufactured by its Diagnostics segment. These patents are used in the company’s manufacturing processes for select products (e.g., method patents) or may relate to the design of the test device technology format (e.g., design patents).
The patents applicable to the company’s Alethia products, which represented 3% of consolidated net revenue for the year ended September 30, 2022 were licensed from a third party, Eiken Chemical Co., Ltd., under a non-exclusive license agreement, with the last remaining the U.S. patent having expired during the year ended September 30, 2022.
The patents for the Revogene platform and related products acquired as part of the GenePOC, Inc. (GenePOC) business are either wholly owned or licensed from two third parties, Laval University and The Regents of California, under an exclusive license agreement. These patents are issued in the U.S., European Union (EU) and other countries. The term of the company’s exclusive license agreement and the related patents currently runs through June 15, 2034, after which it will be free to practice the patents without any restriction or royalty obligation. In September 2021, the U.S. Patent and Trademark Office granted to Meridian Bioscience Canada, Inc. (a wholly owned subsidiary) and Laval University a patent for the company’s current Revogene test device and its microfluidic use in its Revogene instrument.
The patents for the BreathID system and related urea breath test for H. pylori are either wholly owned or licensed from a third party, Oridion Medical 1987 Ltd., under an exclusive, royalty free, license agreement. The licensed and wholly owned patents are issued in the U.S., EU, Israel, Japan, Australia and China. The wholly owned patents have varying expiration dates, with the last being in 2033.
The patents for the company’s stool antigen H. pylori products, owned by it and which represented approximately 5% of consolidated net revenue for the year ended September 30, 2022 expired in May 2016 in the U.S. and in May 2017 in countries outside the U.S. As a result, competition with respect to its stool antigen H. pylori products has increased, adversely impacting its selling prices for these products, and/or its ability to retain business at prices acceptable to it.
Government Regulation
The company’s diagnostic products are regulated by the FDA as devices pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of three classes (i.e., Class I, II or III). Class I and II devices are not expressly approved by the FDA, but instead, are cleared for marketing. Class III devices generally must receive pre-market approval (PMA) from the FDA as to safety and effectiveness. The company’s diagnostics manufacturing facilities are subject to periodic inspection by the FDA.
Each of the diagnostic products currently marketed by Meridian in the U.S. has been cleared, approved or authorized for use by the FDA or are exempt from such requirements. The majority of such products have been cleared by the FDA pursuant to its 510(k) clearance process, with the company’s BreathTek product having been approved under the FDA’s PMA process. In the case of the company’s Revogene SARS-CoV-2 test, it has not been FDA cleared or approved but rather has been authorized by the FDA for emergency use under its Emergency Use Authorization (EUA) process.
The company’s urea breath test for H. pylori on the BreathTek system was approved by the U.S. Food and Drug Administration (FDA) via the pre-market approval (PMA) process in 2012. Following receipt of EUA on November 9, 2021 for its original SARS-CoV-2 test, its Omicron variant enhanced SARS-CoV-2 test on the Revogene platform was submitted to the FDA under its EUA program on March 29, 2022, with EUA being granted on July 27, 2022.
The sales of the company’s diagnostic products in foreign countries are subject to foreign government regulation, which is similar to that of the FDA. The company’s Diagnostics segment facilities are certified to ISO 13485.
Life Science segment
Products and Markets
The company’s Life Science segment develops, manufactures, sells and distributes bulk antigens, antibodies, immunoassay blocking reagents, specialized PCR master mixes, isothermal reagents, enzymes, nucleotides, and bioresearch reagents used predominantly by in vitro device (IVD) manufacturing companies, and to a lesser degree, by researchers and non-human clinical customers, such as veterinary, food and environmental. The company engages direct sales teams in the U.S., the United Kingdom (U.K.), France, Germany, China, and Australia.
The company’s Life Science segment products are marketed to in vitro device (IVD) manufacturing customers as a source of raw materials for their human clinical diagnostics tests, or as an outsourced step in their manufacturing processes. Independent distributors market its molecular biology products to academic/research customers. The company’s products are used in detecting DNA and RNA in human, animal, plant and environmental applications.
Competition
The company’s competitors, such as Thermo Fisher.
Manufacturing and Government Regulation
The company’s Life Science segment facilities are ISO 13485 certified, and where appropriate, its Life Science segment facilities comply with Regulation EC 1069.
History
Meridian Bioscience, Inc. was incorporated in 1976.
