Originally granted on October 14, 2014, the patent\u2014titled \u201cDetection and Use of Antiviral Resistance Mutations\u201d\u2014covers 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<\/a>). A Foundational Technology Supporting HBV Genotyping and Resistance Analysis:<\/p>\n 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.<\/p>\n A Strong Licensing Model and Recurring revenue visibility:<\/p>\n 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\u2019s technology supports a broad international network of diagnostic partners, strengthening its recurring licensing revenues and reinforcing its role in the global HBV diagnostics ecosystem.<\/p>\n An Integrated Offering Combining Assays and Bioinformatics:<\/p>\n ABL Diagnostics offers an integrated workflow combining molecular assays and bioinformatics tools designed to support HBV genomic analysis.<\/p>\n 1. Molecular Assays (Wet Lab)<\/p>\n ABL provides DeepChek\u00ae 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.<\/p>\n 2. Bioinformatics and Data Interpretation Tools (Dry Lab)<\/p>\n ABL provides a range of software tools for sequence analysis and interpretation such as DeepChek\u00ae 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.<\/p>\n 3. An Integrated Workflow Approach<\/p>\n Laboratories generate HBV sequence data using DeepChek\u00ae Assays which may be analyzed using DeepChek\u00ae 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.<\/p>\n \u201cThe 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,\u201d said Ronan Boulm\u00e9, GRC Director at ABL Diagnostics. \u201cABL is proud to support laboratories worldwide with robust technologies and tools contributing to the understanding of HBV genetic variability and resistance patterns.\u201d<\/p>\n A Growing Market Driven by Molecular Diagnostics Adoption:<\/p>\n 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. Evolving Therapeutics Reinforce the Role of Genomic Analysis:<\/p>\n Current HBV treatments include nucleos(t)ide analogues such as entecavir and tenofovir (including tenofovir alafenamide), which have significantly improved viral suppression. About ABL Diagnostics (ABLD): 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.<\/p>\n 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.<\/p>\n An expanding portfolio of microbiology products: Integrated Solutions ABL Diagnostics, headquartered in Woippy, is a public limited company listed on compartment B of the regulated market of Euronext in Paris (Euronext: ABLD \u2013 ISIN: FR001400AHX6). These molecular biology products generate recurring revenues and cover one of the largest portfolios of applications in microbiology.<\/p>\n Contact
\nThe renewal follows the latest USPTO maintenance milestone in 2026, ensuring continued protection of this strategic intellectual property.<\/p>\n
\nThe 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<\/a>).
\nGenotyping and resistance analysis are increasingly used to Characterize viral genetic diversity, Monitor treatment-experienced patients and Support long-term disease management strategies.<\/p>\n
\nhttps:\/\/www.thelancet.com\/journals\/lanmic\/article\/PIIS2666-5247%2825%2900004-7\/fulltext<\/a>
\nHowever, 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.
\nRegulatory Disclaimer : Certain components described, including SeqHepB, are not in vitro diagnostic medical devices and are not CE-IVD marked or FDA cleared. The DeepChek\u00ae Software HBV module is CE-IVD marked in the European Union. Product availability and regulatory status may vary by country.<\/p>\n
\nABL Diagnostics (ABLD) is an international company that specializes in innovative molecular biology tests and global solutions for its customers:
\n– Molecular polymerase chain reaction (PCR) detection \u2013 UltraGene, and
\n– Genotyping by DNA sequencing \u2013 DeepChek\u00ae.<\/p>\n
\n– HIV \u2013 Drug resistance testing, including a whole genome kit.
\n– SARS-CoV-2, Tuberculosis, Hepatitis B and C \u2013 Advanced Detection Solutions.
\n– Microbiome and taxonomy \u2013 16s\/18s RNA-based analyses.
\n– Other viral and bacterial targets \u2013 Comprehensive molecular assays.<\/p>\n
\n– Real-time syndromic PCR tests
\n– Nadis\u00ae \u2013 Patient Medical Record used in more than 200 hospitals in France for the management of HIV and hepatitis.
\n– MediaChek\u00ae \u2013 Clinical Sample Collection Kits.<\/p>\n
\nABL Diagnostics SA
\nSoci\u00e9t\u00e9 anonyme au capital de 1 611 465,60 euros
\nHeadquarters : 72C route de Thionville – 57140 WOIPPY
\n552 064 933 R.C.S. METZ\tTel : +33 (0)7 83 64 68 50
\nEmail : info@abldiagnostics.com
\nhttps:\/\/www.abldiagnostics.com\/<\/a><\/p>\n
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