Meridian Bioscience Achieves IVDR Certification for Alethia® Molecular Assay Portfolio

Key Terms

in vitro diagnostic regulation regulatory

A set of government rules and oversight that determine how laboratory tests run on samples outside the body are evaluated, approved, labeled and monitored for safety and accuracy. Like building codes for diagnostic tests, these regulations shape how quickly a test can reach the market, what evidence companies must produce, and what costs and legal risks they face—factors that directly affect a medical-device or biotech company’s sales potential and investment risk.

ivdr regulatory

A medical-device regulation that sets safety, performance and market-entry rules for in vitro diagnostic tests — the lab tests and kits used to analyze blood, tissue or other samples outside the body. It matters to investors because it shapes which products can be sold, how long approvals take, and how much companies must spend to comply; like a new building code, tighter rules can raise costs and delay launches but also raise barriers for competitors.

ce marking regulatory

CE marking is a symbol placed on certain products showing they meet European Union safety, health and environmental rules required to sell them in the EU/EEA. For investors, it signals that a product has cleared a common regulatory hurdle—like a passport for market access—reducing legal and market-entry risk and often widening sales opportunities across European markets.

notified body regulatory

An independent, government‑designated organization that inspects and certifies medical devices, diagnostic tests, and other regulated products to verify they meet safety and performance rules required for sale in certain markets. Think of it as an official inspector or stamp of approval: its approval affects whether a product can be legally marketed, the timing of launch, and the company’s costs and regulatory risk—key factors for investors assessing commercial prospects.

post-market surveillance regulatory

Post-market surveillance is the ongoing monitoring of a product’s safety and performance after it has been approved and sold, especially for drugs and medical devices. Like watching cars after they leave the showroom to catch hidden defects, it matters to investors because problems discovered later can trigger recalls, regulatory fines, extra testing, or damaged reputation — all of which can reduce future sales and hurt a company’s financial outlook.

molecular diagnostics medical

Molecular diagnostics are laboratory tests that look for specific molecules — such as genes, pieces of DNA or RNA, or proteins — to detect disease, predict risk, or guide treatment choices. For investors, these tests matter because they can change how illnesses are diagnosed and treated, create recurring revenue through specialized tests and companion products, and face clear regulatory and reimbursement pathways that drive commercial value; think of them as reading a biological barcode to inform medical decisions.

molecular testing medical

Molecular testing analyzes tiny biological markers—like DNA, RNA or specific proteins—to detect diseases, identify pathogens or measure treatment-related changes. Think of it as reading a biological barcode or fingerprint that tells doctors exactly what is happening at the cellular level. For investors, molecular tests matter because they drive demand for diagnostic products, influence clinical trial outcomes and regulatory decisions, and can quickly change revenue and valuation when adopted in clinical care.

CINCINNATI--(BUSINESS WIRE)-- Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

The certification, issued by GMED (Notified Body 0459), confirms that the following Alethia assays and associated external controls are compliant with IVDR requirements and are classified as Class C under the regulation:

• Alethia Pertussis and Alethia Pertussis External Controls
• Alethia GBS and Alethia GBS External Controls
• Alethia CMV and Alethia CMV External Controls
• Alethia Malaria and Alethia Malaria External Controls
• Alethia Chlamydia
• Alethia Gonorrhea
• Alethia HSV 1&2 and Alethia HSV 1&2 External Controls

IVDR represents a significant evolution in the European regulatory framework for in vitro diagnostics, introducing more rigorous requirements for clinical evidence, performance evaluation, quality systems, and post-market surveillance. Achieving IVDR certification underscores Meridian’s commitment to delivering high-quality, compliant diagnostic solutions to laboratories and healthcare providers across Europe.

“This milestone reflects the strength of our quality systems and the dedication of our regulatory, quality, and product teams,” said Susan Bogar, Vice President, Regulatory Affairs at Meridian Bioscience. “We are proud to continue supporting our European customers with IVDR-compliant molecular diagnostics that deliver reliable, actionable results.”

“This achievement reflects Meridian’s unwavering commitment to quality, regulatory excellence and customer continuity,” said Andy Kitzmiller, Chief Executive Officer of Meridian Bioscience. “The transition to IVDR is one of the most demanding regulatory shifts our industry has faced. Successfully certifying our Alethia product demonstrates the strength of our teams and reinforces our long-term dedication to supporting healthcare providers across Europe with reliable, high-performance molecular diagnostics.”

The Alethia platform provides rapid, easy-to-use molecular testing designed to streamline workflows and deliver accurate detection of infectious diseases in clinical laboratory settings. With IVDR certification in place, Meridian reinforces its long-term commitment to the European market and to maintaining uninterrupted product availability during the industry-wide regulatory transition.

Meridian Bioscience will continue to advance its portfolio in alignment with evolving global regulatory standards while supporting customers through ongoing compliance and market access requirements.

About Meridian Bioscience, Inc.

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes diagnostic testing solutions and life science raw materials. Meridian’s diagnostic products provide accurate, simple, and cost-effective testing solutions to aid in the diagnosis and management of gastrointestinal, respiratory, parasitic, and other infectious diseases. The Company’s Life Science segment supplies critical raw materials used by researchers and other diagnostic manufacturers worldwide.

For more information, visit www.meridianbioscience.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260224854690/en/

Michelle Bosch, Vice President, Global Commercial Marketing and Business Management, DIAGNOSTICS

michelle.bosch@meridianbioscience.com

Source: Meridian Bioscience, Inc.