“ABL Diagnostics Launches DeepChek®-HPV Assay for Efficient Human Papillomavirus Screening, Genotyping, and Sequencing”

ABL Diagnostics, a publicly-listed company on Euronext (FR001400AHX6 – ABLD), has announced the release of its new DeepChek®-HPV Assay and software on Thursday, January 18th, 2024. This innovative solution aims to screen, genotype, and discriminate the Human Papillomavirus (HPV), a virus known to cause genital warts and cancer.

The DeepChek®-HPV Assay uses an advanced design that allows laboratories to perform reflex genotyping (Research Use Only) through Next Generation Sequencing (NGS) on positive samples. This enables further analysis of genetic evolution, prevention and control measures, and the development of therapeutic regimens and products. The assay utilizes the amplicons of a CE-IVD qPCR assay, which is intended for HPV detection and is distributed by ABL Diagnostics.

The solution has been validated on multiple NGS platforms and includes a CE IVD marked downstream analysis software, accessible through secured Cloud or local installations. This allows for precise genotyping of the viruses and the ability to discriminate between oncogenic and non-oncogenic strains.

The DeepChek® technology also allows for the pooling of HPV samples with other types of samples, such as HIV and viral hepatitis, resulting in increased efficiency, reduced turnaround time, and lower sequencing costs. This makes it easier for high-throughput laboratories to transition to NGS technology.

The global market for HPV testing is estimated to reach US$2.2 billion in 2021, with a projected value of US$15 billion by 2032.

Dimitri Gonzalez, Head of Diagnostics at ABL Diagnostics, stated, “The implications of HPV infection are clear as it impacts populations worldwide. Offering our customers and partners a robust solution to screen, discriminate, and genotype this virus is an important step for ABL Diagnostics. It complements our portfolio of microbiology applications and has the potential to become a flagship product alongside our GenomeMe technology.”

Sofiane Mohamed, Head of Research and Development, added, “The ability to quickly screen for HPV infection and to genotype and discriminate between oncogenic and non-oncogenic strains is critical. Our team has used our accumulated experience in viral genomics and collaborated with GenomeMe to provide high-quality, efficient, and cost-effective services for HPV genetic evolution analysis, infectious disease prevention and control, therapeutic regimen development, and product development to limit clinical complications in the general population.”

ABL Diagnostics is a leading international company that offers innovative molecular biology assays and end-to-end solutions for molecular detection and genotyping. Their products cover a wide range of microbiology applications, with a primary focus on HIV, SARS-CoV-2, tuberculosis, and viral hepatitis B and C. The company also develops and markets kits for clinical specimen collection and digital solutions, such as Nadis®, an Electronic Medical Record system used in over 200 hospitals in France.

For more information, please visit www.abldiagnostics.com.

Media Contact:

Ronan Boulme

General Manager, ABL Diagnostics

Tel: +33 7 83 64 68 50

Email: info@abldiagnostics.com

Forward-Looking Statements:

This press release contains certain implicit or explicit forward-looking statements regarding ABL Diagnostics and its business. These forward-looking statements are based on assumptions that ABL Diagnostics considers reasonable but are subject to numerous risks, including those outlined in the “Risk Factors” section of the company’s universal registration document filed with the AMF on July 12, 2022, under number 22-296. The occurrence of any of these risks could cause the actual results, financial condition, performance, or achievements of ABL Diagnostics to differ materially from the forward-looking statements. This press release and the information contained herein should not be construed as an offer or invitation to sell or subscribe to ABL Diagnostics shares in any country, as distribution of this press release in certain countries may be a violation of applicable laws. Those in possession of this press release should inquire about any local restrictions and comply with them.

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