Independent clinical validation strengthens ABL’s leadership in the fast‑growing HIV drug‑resistance testing market
ABL Diagnostics SA (EPA:ABLD – ISIN : FR001400AHX6)
WOIPPY, MOSELLE, FRANCE, March 11, 2026 /EINPresswire.com/ — ABL Diagnostics (FR001400AHX6 – “ABLD”) announces strengthened positioning in HIV‑1 genomics following the publication of a peer‑reviewed scientific article (Moriceau et al.) in Journal of Clinical Virology Plus validating the Company’s DeepChek® Whole Genome HIV‑1 Genotyping kit, the only full‑genome HIV‑1 genotyping assay holding CE‑IVD certification worldwide.
The study demonstrates that whole‑genome sequencing using ABL’s technology is feasible in routine diagnostic laboratories, provides comprehensive resistance profiling, and reliably identifies mutations across all genomic regions, including minority variants and mutations outside the classical pol region relevant to emerging therapeutic classes.
The article further highlights the robustness of the ABL Diagnostics workflow, which also includes the DeepChek® HIV Software, a CE‑IVD‑certified bioinformatics platform specifically designed to analyze and interpret any CE‑IVD HIV‑1 sequencing output, whether derived from target‑specific assays or from whole‑genome sequencing. This software processes raw FASTQ data and converts them into clinically interpretable resistance reports, ensuring consistent and standardized interpretation aligned with international guidelines.
This scientific validation comes at a time when the global market for HIV genotypic resistance testing, valued at approximately USD 1.34 billion in 2024, is projected to reach USD 2.51 billion by 2033, growing at around 7.2% CAGR , driven by the rising prevalence of HIV and increased adoption of personalized antiretroviral therapy worldwide. International authorities—including the World Health Organization (WHO) and U.S. guideline panels—identify genotypic drug‑resistance testing as essential for initiating or adapting antiretroviral therapy, reinforcing sustained global demand. In parallel, the global HIV diagnostics market is expected to exceed USD 6.64 billion by 2031, with molecular and NGS‑based solutions experiencing the strongest growth .
Within this expanding market, ABL Diagnostics confirms it offers 15 HIV‑1 genotyping assays, available as CE‑IVD and RUO versions, spanning Sanger‑based, NGS‑based and whole‑genome workflows. This comprehensive portfolio enables laboratories with varying infrastructure levels and regulatory constraints to deploy harmonized, high‑quality resistance monitoring strategies aligned with evolving therapeutic standards.
From a financial standpoint, ABL Diagnostics reported revenue of €2.85 million for the first half of 2025, compared to €2.73 million for the same period in 2024. Growth was primarily driven by the HIV franchise, with DeepChek® HIV products generating €1.20 million, an increase of 73% year‑on‑year, while net income reached €288 thousand. The Company also reported a positive net cash position of approximately €1.77 million as of 30 June 2025, supporting continued investment in R&D and global commercial expansion .
As outlined in its regulated disclosures, ABL Diagnostics operates in a market subject to increasing regulatory, technical and automation requirements. The Company has oriented its R&D and Regulatory strategy accordingly to strengthen and expand its global competitive position.
Dr Sofiane Mohamed, Head of Research & Development at ABL Diagnostics, stated that “this peer‑reviewed validation confirms the scientific and clinical strength of our whole‑genome HIV‑1 assay—today the world’s only CE‑IVD‑certified full‑genome solution—and demonstrates the importance of comprehensive sequencing in an evolving therapeutic landscape. Paired with our CE‑IVD DeepChek® HIV Software, our HIV portfolio of 15 IVD and RUO assays offers laboratories a complete and future‑proof approach to HIV drug‑resistance testing for diagnostics, epidemiology and research.”
ABL Diagnostics believes that the combination of unique CE‑IVD full‑genome technology, certified analytical software, broad portfolio coverage, and strengthening financial performance provides a solid foundation for long‑term value creation. Forward‑looking statements remain subject to market conditions, regulatory developments and competitive factors described in the Company’s public filings.
About ABL Diagnostics (ABLD)
ABL Diagnostics (ABLD) is an international company that specializes in innovative molecular biology tests and global solutions for its customers:
• Molecular polymerase chain reaction (PCR) detection – UltraGene, and
• Genotyping by DNA sequencing – DeepChek®.
ABL Diagnostics markets its entire product range globally through its own sales team and a network of exclusive distributors active on all continents. ABL Diagnostics’ customers are academic clinical pathology laboratories, private reference laboratories and researchers willing to implement innovative and robust microbiological content in constant expansion.
ABL Diagnostics has been marketing the products and services of its sister company CDL Pharma since the second half of 2025 through an intra-group strategy agreement.
An expanding portfolio of microbiology products:
• HIV – Drug resistance testing, including a whole genome kit.
• SARS-CoV-2, Tuberculosis, Hepatitis B and C – Advanced Detection Solutions.
• Microbiome and taxonomy – 16s/18s RNA-based analyses.
• Other viral and bacterial targets – Comprehensive molecular assays.
Integrated Solutions
• Real-time syndromic PCR tests
• Nadis® – Patient Medical Record used in more than 200 hospitals in France for the management of HIV and hepatitis.
• MediaChek® – Clinical Sample Collection Kits.
ABL Diagnostics, headquartered in Woippy, is a public limited company listed on compartment B of the regulated market of Euronext in Paris (Euronext: ABLD – ISIN: FR001400AHX6). These molecular biology products generate recurring revenues and cover one of the largest portfolios of applications in microbiology.
Dr Sayada
ABL Diagnostics SA
+33 7 83 64 68 50
email us here
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