ABL Diagnostics wins CE-IVD clearance for whole-genome HIV resistance test

ABL Diagnostics said July 31 that its DeepChek Whole Genome HIV-1 Genotyping v1.2 has been CE-IVD registered in Europe. The update adds stronger sensitivity at low viral loads and keeps the same workflow, positioning the assay as a broad HIV drug-resistance test for clinical labs.

Why it matters: - The CE-IVD registration gives ABL Diagnostics a regulated whole-genome HIV drug-resistance test for clinical use in Europe. - The assay targets a wider range of resistance mutations than conventional HIV genotyping tests, which can improve decision-making as HIV treatment becomes more personalized. - ABL Diagnostics says the update is designed to fit into existing laboratory workflows, lowering adoption barriers for labs already using earlier versions.

What happened: - ABL Diagnostics announced the CE-IVD registration of DeepChek® Whole Genome HIV-1 Genotyping v1.2 on July 31, 2026. - The product was registered by ABL SA in Luxembourg, the legal manufacturer. - The company described the test as the first and only CE-IVD whole-genome HIV assay with 500 copies/mL sensitivity for comprehensive drug-resistance testing.

The details: - DeepChek® Whole Genome HIV-1 Genotyping v1.2 keeps the same validated primer design and PCR strategy used in previous versions. - The assay amplifies five HIV-1 genomic fragments before next-generation sequencing and bioinformatics analysis. - Labs using earlier versions can keep their current workflow, protocols and downstream analysis software. - Analytical performance showed a limit of detection of 500 HIV RNA copies/mL for fragments 1, 2, 4 and 5. - Fragment 3 showed a limit of detection of 25,000 copies/mL. - At 250 copies/mL, the assay achieved 95% detection for Fragment 1 and 100% for Fragments 4 and 5. - The test sequences virtually the complete HIV-1 genome, including the 5' and 3' long terminal repeats, gag, pol, vif, vpr, tat, rev, vpu, env and nef. - The coverage supports resistance characterization across capsid inhibitors, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, fusion inhibitors and post-attachment inhibitors. - The assay is compatible with multiple sequencing platforms, including Illumina, MGI Tech, Ion Torrent, Oxford Nanopore Technologies, Element Biosciences, PacBio and Salus. - The assay has also been verified with most manual and automated nucleic acid extraction workflows used in molecular labs. - DeepChek® integrates with ABL Diagnostics' CE-IVD bioinformatics tools, DeepChek® HIV and MicrobioChek HIV, available locally or through a secure HDS-certified cloud. - The company says the broader workflow can include OpenChek laboratory automation and a rapid library-preparation process completed in about two hours. - The RUO version remains available for academic research, pharmaceutical development, clinical studies and HIV surveillance programs.

Between the lines: - The product update appears aimed at labs that want broader HIV resistance coverage without changing their current setup. - Whole-genome sequencing may become more important as new treatment classes, including capsid inhibitors and long-acting therapies, expand the resistance-testing burden. - ABL Diagnostics is using the launch to reinforce a strategy built around an end-to-end diagnostics stack that includes sample prep, sequencing, bioinformatics and automation.

What's next: - ABL Diagnostics says product availability may vary by local regulatory requirements. - Clinical labs can begin using the CE-IVD version under professional-use rules, while the RUO version remains for non-diagnostic research. - The company is positioning the assay as a platform that can support both current and future HIV therapies without redesigning the workflow.

The bottom line: - ABL Diagnostics now has a CE-IVD whole-genome HIV test that pairs broad resistance coverage with easier lab adoption.