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Meridian Bioscience Announces Health Canada License for Alethia® CMV Assay

Key Takeaway: Meridian Bioscience, Inc. has received a license from Health Canada for its Alethia® CMV assay. This new addition broadens Meridian's existing Alethia menu, which already includes various assays for other pathogens. The approval enhances the company's molecular diagnostic capabilities in the Canadian market.
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POSITIVE FACTORS

  • Health Canada has granted a license for Alethia® CMV assay.
  • The new assay expands Meridian's diagnostic offerings.
  • The addition enhances the existing Alethia menu.

Full Press Release Details

CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that Health Canada has granted a license for its Alethia®CMV assay. The addition of CMV expands Meridian's existing Alethia menu, which includes C. difficile, Group A Strep, Group B Strep, malaria, Mycoplasma, and pertussis assays. This clearance expands Meridian's molecular diagnostic offerings in the Canadian market.
The Alethia platform delivers accurate molecular results in less than an hour to support evidence-based clinical decisions. With a small footprint and simple workflow, Alethia helps labs run efficiently while delivering reliable molecular results. The platform uses LAMP technology (loop-mediated isothermal amplification) for a cost-effective molecular solution.
With the Alethia CMV assay, Meridian delivers highly sensitive molecular detection with rapid turnaround time. Nearly 1 in 4 women carry cytomegalovirus (CMV), the most common congenital infection transmitted from mother to baby during pregnancy.1,2Every year 1 in 200 babies are born with congenital CMV, and yet, the majority of pregnant women have never heard of it.3Alethia CMV enables early detection of congenital CMV, which is vital in guiding appropriate clinical care for newborns. Congenital CMV testing empowers physicians and families with a full understanding of their newborn’s health prior to leaving the hospital.
“We are excited about the expanded menu offering of CMV on our Alethia platform in Canada. This allows Meridian to provide an important diagnostic solution for customers in the Canadian market. By utilizing saliva as the sample type, the assay delivers an easy-to-collect specimen for congenital CMV testing,” said Michelle Bosch, Vice President of Global Marketing. “The Alethia CMV assay provides clinicians with a valuable tool to aid in the diagnosis of congenital CMV.”

About Meridian Bioscience, Inc.

Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic and life science products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world. Meridian is a privately held company headquartered in Cincinnati, Ohio. Meridian’s website address iswww.meridianbioscience.com.
1. | Silasi M, Cardenas I, Racicot K, Kwon J-Y, Aldo P, Mor G. VIRAL INFECTIONS DURING PREGNANCY. American Journal Of Reproductive Immunology (New York, NY : 1989). 2015;73(3):199-213. doi:10.1111/aji.12355. 2. Marchofdimes.org. (2018).
3. | Congenital CMV Facts. Centers for Disease Control and Prevention.https://www.cdc.gov/cytomegalovirus/congenital-infection/index.html.
Michelle Bosch, Vice President, Global Commercial Marketing and Business Management, DIAGNOSTICSMeridian Bioscience, Inc.Phone: 513.271.3700Email:mbi@meridianbioscience.comormichelle.bosch@meridianbioscience.com

Frequently Asked Questions

What is the Alethia® CMV assay?

The Alethia® CMV assay is a diagnostic test developed by Meridian Bioscience for detecting cytomegalovirus.

Who granted the license for the Alethia® CMV assay?

Health Canada granted the license for the Alethia® CMV assay.

What other assays are included in the Alethia menu?

The Alethia menu includes assays for C. difficile, Group A Strep, Group B Strep, malaria, Mycoplasma, and pertussis.

How does this license impact Meridian's offerings?

The license expands Meridian's molecular diagnostic offerings in the Canadian market.

Last updated: Jul 14, 2026