ABL Diagnostics launches UltraGene Respiratory Pathogens 21 after CE-IVD registration

ABL Diagnostics said UltraGene Respiratory Pathogens 21 is now commercially available after CE-IVD registration through ABL SA Luxembourg, giving laboratories a new automated respiratory PCR assay for 21 pathogens. The launch extends the company’s legacy Fast Track Diagnostics portfolio and supports its broader transition toward EU IVDR compliance.

Why it matters: - UltraGene Respiratory Pathogens 21 expands ABL Diagnostics’ respiratory syndromic testing line with a multiplex real-time PCR assay for 21 viral and bacterial pathogens. - The product gives laboratories another CE-IVD option that can run on ABL Diagnostics’ OpenChek platform, which is meant to reduce hands-on time and improve workflow standardization. - The launch helps preserve access to an established respiratory assay while ABL Diagnostics works through the European IVDR transition.

What happened: - ABL Diagnostics announced the commercial availability of UltraGene Respiratory Pathogens 21 on July 27, 2026. - ABL SA Luxembourg obtained CE-IVD registration for the assay under Council Directive 98/79/EC as the legal manufacturer. - ABL Diagnostics SA will handle worldwide commercialization, distribution and customer support. - The assay is commercialized under the transitional provisions of Regulation (EU) 2017/746, subject to continued regulatory compliance for legacy devices.

The details: - UltraGene Respiratory Pathogens 21 is intended for qualitative detection and differentiation of 21 respiratory pathogens. - The complete workflow can be automated on the OpenChek platform. - The assay comes from the former Fast Track Diagnostics molecular diagnostic portfolio transferred to the ABL group after a 2025 know-how and technology transfer agreement with Siemens Healthineers. - Manufacturing, technical documentation and quality processes were transferred before the assay was released under ABL SA Luxembourg’s quality management system. - The intended purpose, technological principles and core performance characteristics remain consistent with the previously marketed FTD product. - ABL Diagnostics says the continuity is meant to support laboratories that have relied on the earlier assay. - The company says it has re-established industrial production and global commercialization of the portfolio under the UltraGene brand. - ABL Diagnostics says distribution now spans Europe, the Middle East, Africa, Asia and Latin America. - The assay is part of a broader program to maintain and commercialize selected legacy products from the former FTD portfolio. - These products are being managed under IVDD and IVDR transitional provisions, so long as regulatory conditions continue to be met and no significant changes affect intended purpose or design. - ABL SA Luxembourg is working with notified body BSI on its IVDR conformity assessment roadmap. - The approach is designed to support regulatory continuity and long-term availability for clinical laboratories worldwide. - UltraGene Respiratory Pathogens 21 complements ABL’s broader molecular diagnostics portfolio.

Between the lines: - The launch shows ABL Diagnostics is trying to turn legacy FTD assays into a durable commercial platform rather than a one-off transfer. - The company is pairing CE-IVD continuity with an IVDR transition plan, which matters because European regulatory changes can affect whether older assays stay on the market. - The company framed the product as both a continuity play for existing labs and a foundation for future portfolio development. - Ronan Boulmé, GRC Director at ABL Diagnostics and PRRC for ABL SA Luxembourg, said the CE-IVD availability alongside the RUO model marks an important milestone in integrating the former FTD portfolio. - ABL Diagnostics said several new syndromic qPCR assays are under development for respiratory, central nervous system, gastrointestinal and tropical infectious diseases. - The company also pointed to growth in the respiratory syndromic testing market, citing rising demand for rapid differential diagnosis, antimicrobial stewardship, infection control and outbreak preparedness. - The company cited MarketsandMarkets projections that the global syndromic multiplex diagnostics market will rise from about $2.6 billion in 2024 to more than $5.0 billion by 2029. - The company also cited Grand View Research as projecting continued double-digit growth for multiplex molecular diagnostics.

What's next: - ABL SA Luxembourg will continue its IVDR transition program for former FTD products. - ABL Diagnostics expects to keep expanding its syndromic assay pipeline across multiple infectious disease areas. - The company will continue global commercialization through its sales team and exclusive distributors. - ABL Diagnostics says the portfolio is positioned for broader use as laboratories seek scalable respiratory testing options.

The bottom line: - UltraGene Respiratory Pathogens 21 is both a product launch and a regulatory continuity move, aimed at keeping an established respiratory PCR assay available while ABL Diagnostics advances its EU compliance strategy.