ABL Diagnostics advances UltraGene Ebola multiplex qPCR assay

By AI, Created 3:51 PM UTC, May 28, 2026, /AGP/ – ABL Diagnostics says it is developing an UltraGene Ebola multiplex qPCR assay to improve detection coverage for selected Ebola disease-causing viruses, including Bundibugyo virus. The program is aimed at outbreak preparedness, species differentiation and future regulatory readiness, with validation and performance studies still ahead.

Why it matters: - The UltraGene Ebola program targets faster molecular detection and species differentiation for Ebola outbreaks, where early lab confirmation can shape containment and response. - ABL Diagnostics is aiming to broaden coverage beyond a single Ebola target, which could improve practical use in outbreak settings if the assay is validated. - The company is also building documentation and validation paths that could support future regulatory review in different jurisdictions.

What happened: - ABL Diagnostics announced continued progress on its UltraGene qPCR Ebola assay portfolio on May 28, 2026. - The assay is being developed to support molecular detection of selected Ebola disease-causing viruses, including Bundibugyo virus. - The company said the work is designed for outbreak-readiness needs raised by regulatory authorities, public-health agencies and laboratory stakeholders. - ABL Diagnostics said the current program includes a multiplex qPCR assay intended to detect additional Ebola disease-causing viruses within a single workflow. - The company said the assay remains under development and performance evaluation studies are planned.

The details: - The UltraGene Ebola assay is intended to support simultaneous detection and differentiation of selected Ebola virus species in one laboratory qPCR process, subject to validation. - ABL Diagnostics said the program builds on technologies and know-how linked to the Fast Track Diagnostics product family. - The company said that historical expertise includes molecular assays targeting Ebola disease associated with Zaire ebolavirus. - ABL Diagnostics said its broader Ebola diagnostics effort is part of a strategy to strengthen preparedness against emerging infectious diseases. - The company said the effort follows earlier work on a syndromic PCR panel that included Hantavirus detection. - The company said the current Bundibugyo virus outbreak reinforces the need for molecular diagnostic tools that support detection, species differentiation and outbreak preparedness. - ABL Diagnostics said scalable laboratory readiness remains important for early case identification, transmission monitoring and containment support. - The company intends to move UltraGene Ebola through assay design, analytical validation, clinical performance evaluation where appropriate and readiness for independent external evaluation. - ABL Diagnostics said it aims to build evidence packages that may support future regulatory interactions, including technical documentation, performance data, risk management documentation, manufacturing controls and post-market planning. - The company said its UltraGene qPCR portfolio is being expanded to address emerging and re-emerging infectious threats. - ABL Diagnostics said the development strategy is meant to translate outbreak-response needs into practical outputs such as target coverage, multiplex differentiation, validation readiness, regulatory documentation and possible deployment planning. - The company said UltraGene Ebola is not WHO EUL listed, FDA-authorized, CE-marked or otherwise regulatory cleared at this stage. - ABL Diagnostics said any future availability or use will depend on successful validation, applicable regulatory pathways and country-specific requirements. - Dr. Sofiane Mohamed, head of R&D at ABL Diagnostics, said Ebola virus disease remains a critical global health challenge because of viral diversity, outbreak unpredictability and the need for rapid laboratory response. - Dr. Mohamed said the goal is to develop a multiplex qPCR solution supporting Bundibugyo virus coverage, Ebola species differentiation, validation readiness and regulatory preparedness, subject to validation and applicable requirements.

Between the lines: - ABL Diagnostics is positioning UltraGene Ebola as a preparedness product, not a finished commercial launch. - The emphasis on multiplex detection suggests the company sees value in one assay handling multiple Ebola targets instead of separate tests. - The regulatory language signals that the company is trying to build a dossier early, before any broader market rollout. - The WHO reference and the mention of a current Bundibugyo outbreak underscore the public-health context behind the development push.

What’s next: - ABL Diagnostics plans performance evaluation studies for the assay. - The company says it will continue the structured development pathway toward analytical validation and clinical performance work where appropriate. - Future steps may include independent external evaluation and preparation for regulatory interactions. - Any market availability would come only after validation and completion of applicable regulatory requirements.