Reinforcing long-term IP strength in molecular diagnostics and supporting global laboratory partners
WOIPPY, FRANCE, June 15, 2026 /EINPresswire.com/ -- ABL Diagnostics (FR001400AHX6 – “ABLD”), a specialist in molecular diagnostics, bioinformatics and decision-support solutions for infectious diseases, today announces that its parent company, Advanced Biological Laboratories (ABL) S.A. (Luxembourg), has successfully renewed a key United States patent, US 8,859,198 B2, reinforcing its long-term commitment to innovation in hepatitis B virus (HBV) genotyping and antiviral resistance analysis.Originally granted on October 14, 2014, the patent—titled “Detection and Use of Antiviral Resistance Mutations”—covers technologies for identifying HBV variants associated with reduced susceptibility to antiviral therapies. The invention remains active with an expected expiration around August 19, 2029. (https://patents.google.com/patent/US8859198B2/en).
The renewal follows the latest USPTO maintenance milestone in 2026, ensuring continued protection of this strategic intellectual property.
A Foundational Technology Supporting HBV Genotyping and Resistance Analysis:
US 8,859,198 B2 covers the characterization and detection of hepatitis B viral mutations associated with altered response to widely used antiviral treatments such as lamivudine, adefovir, entecavir, or tenofovir. These capabilities support laboratory-based analysis of HBV genetic profiles and contribute to ongoing research and monitoring strategies in chronic hepatitis B.
A Strong Licensing Model and Recurring revenue visibility:
Through ABL S..A, this patented technology is licensed to leading reference laboratories worldwide. These laboratories leverage the patented methods to perform HBV genotyping and antiviral resistance analysis as part of their testing workflows. ABL’s technology supports a broad international network of diagnostic partners, strengthening its recurring licensing revenues and reinforcing its role in the global HBV diagnostics ecosystem.
An Integrated Offering Combining Assays and Bioinformatics:
ABL Diagnostics offers an integrated workflow combining molecular assays and bioinformatics tools designed to support HBV genomic analysis.
1. Molecular Assays (Wet Lab)
ABL provides DeepChek® Assays, targeted and whole-genome, designed for HBV genotyping, Detection of resistance-associated and vaccine escape mutations and Use with PCR amplification and sequencing workflows (Sanger or NGS). These assays enable laboratories to generate HBV sequence data from patient samples.
2. Bioinformatics and Data Interpretation Tools (Dry Lab)
ABL provides a range of software tools for sequence analysis and interpretation such as DeepChek® Software (HBV module), CE-IVD marked in the European Union, providing validated analysis and reporting functionalities in accordance with applicable IVD regulations and SeqHepB, an online data interpretation and research-use platform for Resistance-associated mutations identification, Genotype determination and resistance profiling and Standardized interpretation outputs generation. SeqHepB is intended for research or informational purposes only and is not a CE-IVD or FDA-cleared medical device.
3. An Integrated Workflow Approach
Laboratories generate HBV sequence data using DeepChek® Assays which may be analyzed using DeepChek® Software (within its regulatory scope) and additional interpretation may be performed using SeqHepB. The availability and regulatory status of each component vary depending on the country.
“The renewal of US 8,859,198 B2 highlights the enduring importance of HBV genotyping and resistance analysis in the context of long-term antiviral treatment,” said Ronan Boulmé, GRC Director at ABL Diagnostics. “ABL is proud to support laboratories worldwide with robust technologies and tools contributing to the understanding of HBV genetic variability and resistance patterns.”
A Growing Market Driven by Molecular Diagnostics Adoption:
The global demand for HBV genotyping continues to expand, driven by the significant burden of chronic hepatitis B, affecting nearly 296 million people worldwide, and the increasing adoption of molecular diagnostic technologies.
The HBV genotyping market was valued at approximately USD 1.19 billion in 2024 and is projected to grow steadily. (https://dataintelo.com/report/hbv-genotyping-market).
Genotyping and resistance analysis are increasingly used to Characterize viral genetic diversity, Monitor treatment-experienced patients and Support long-term disease management strategies.
Evolving Therapeutics Reinforce the Role of Genomic Analysis:
Current HBV treatments include nucleos(t)ide analogues such as entecavir and tenofovir (including tenofovir alafenamide), which have significantly improved viral suppression.
https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247%2825%2900004-7/fulltext
However, as for HIV, Resistance-associated mutations may still emerge in certain contexts, Long-term monitoring remains important and New therapeutic approaches are under development. These trends reinforce the importance of tools and technologies enabling detailed viral genomic analysis.
Regulatory Disclaimer : Certain components described, including SeqHepB, are not in vitro diagnostic medical devices and are not CE-IVD marked or FDA cleared. The DeepChek® Software HBV module is CE-IVD marked in the European Union. Product availability and regulatory status may vary by country.
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.
Contact
ABL Diagnostics SA
Société anonyme au capital de 1 611 465,60 euros
Headquarters : 72C route de Thionville - 57140 WOIPPY
552 064 933 R.C.S. METZ Tel : +33 (0)7 83 64 68 50
Email : info@abldiagnostics.com
https://www.abldiagnostics.com/
Dr Sayada
ABL Diagnostics SA
+33 7 83 64 68 50
email us here
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