- Health Canada licensed Meridian Bioscience’s Alethia CMV assay, expanding the Alethia molecular diagnostics menu in Canada to include CMV alongside assays for C. difficile, Group A/B Strep, malaria, Mycoplasma, and pertussis.
- The Alethia CMV assay uses LAMP technology to deliver accurate molecular results in less than an hour with a simple workflow and saliva-based saliva collection, enabling rapid congenital CMV detection and supporting timely clinical decision-making.
- Congenital CMV is the most common congenital infection transmitted during pregnancy, affecting 1 in 200 newborns annually, while nearly 1 in 4 women carry CMV. Early diagnosis helps guide appropriate care before newborns leave the hospital.
- Meridian said the approval strengthens its molecular diagnostics portfolio in Canada, providing clinicians with a saliva-based testing solution to improve early congenital CMV detection and patient management.
Takeaways:
The licensing of Alethia CMV gives Meridian a saliva-based, rapid molecular test for congenital CMV that can be deployed in the hours after birth, shifting detection from delayed or invasive methods to an easy, hospital-friendly workflow and expanding its Canadian molecular diagnostics portfolio.
By enabling faster congenital CMV diagnosis in the first days of life, the assay should improve timeliness of care, pediatric and infectious disease management, and parent counseling, while positioning Meridian alongside its C. difficile, Strep, malaria, Mycoplasma, and pertussis tests as a broader, high-throughput molecular diagnostics provider in Canada.
Source: Businesswire
