ABL Diagnostics rolls out UltraGene Viral Meningitis after CE-IVD registration

ABL Diagnostics has made UltraGene Viral Meningitis commercially available after CE-IVD registration through ABL SA Luxembourg. The multiplex PCR assay targets major viral causes of meningitis and other CNS infections and is designed to help labs speed diagnosis and streamline workflows.

Why it matters: - UltraGene Viral Meningitis adds a new syndromic test for central nervous system infections, where fast molecular diagnosis can shape treatment decisions. - The assay is built for cerebrospinal fluid testing and covers the viral pathogens most often linked to meningitis-like symptoms. - The product also extends ABL Diagnostics’ UltraGene portfolio as the company broadens distribution across multiple regions.

What happened: - ABL Diagnostics announced the commercial availability of UltraGene Viral Meningitis following CE-IVD registration by ABL SA Luxembourg. - The assay is a multiplex real-time PCR test for qualitative detection and differentiation of major viral pathogens associated with meningitis and other CNS infections. - ABL Diagnostics SA will handle worldwide commercialization, distribution and customer support.

The details: - The assay simultaneously detects HSV-1, HSV-2, VZV, Mumps virus, Enterovirus and Human parechovirus from CSF specimens. - The full workflow can be automated on ABL Diagnostics’ OpenChek platform. - Automation is intended to streamline sample processing, reduce hands-on time and improve workflow standardization. - The product was registered under Council Directive 98/79/EC (IVDD) through ABL SA Luxembourg, which acts as the legal manufacturer. - The device is being commercialized under the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. - Continued availability depends on compliance with the regulatory requirements for legacy devices. - Manufacturing, technical documentation and quality processes were transferred to ABL SA Luxembourg. - UltraGene Viral Meningitis retains the intended purpose, technological principles and core performance characteristics of the former Fast Track Diagnostics product.

Between the lines: - ABL Diagnostics is using the UltraGene brand to re-establish industrial production and global commercialization of legacy Fast Track Diagnostics assays. - The company says the portfolio has gained traction with clinical microbiology laboratories across Europe, the Middle East, Africa, Asia and Latin America. - The regulatory approach is designed to keep legacy assays available while ABL SA Luxembourg moves products into its IVDR transition program. - The company is working with notified body BSI as part of its broader IVDR conformity assessment roadmap. - The market backdrop favors syndromic CNS testing, with clinical guidelines increasingly recommending CSF testing for herpes simplex viruses, varicella-zoster virus, enteroviruses and parechoviruses. - Industry analyses point to double-digit annual growth in the global multiplex molecular diagnostics market, including expansion beyond respiratory testing into CNS, gastrointestinal and bloodstream infections.

What’s next: - ABL SA Luxembourg will continue reviewing former FTD products under its IVDR transition program. - The company aims to preserve regulatory continuity and long-term availability for the transferred assay portfolio. - UltraGene Viral Meningitis will support labs seeking scalable molecular diagnostics as CNS syndromic testing adoption expands.

The bottom line: - UltraGene Viral Meningitis gives ABL Diagnostics a CE-IVD-registered CNS test that combines legacy assay continuity, OpenChek automation and a pathway into the EU IVDR framework.