ABL Diagnostics - TEXCELL Strengthens Its Position as an International Reference in Safety and Viral Clearance With a New Strategic Partnership With ABIONYX Pharma

• Selection of ABL Diagnostics' TEXCELL division for CER-001 viral safety and clearance studies

• Support for a key stage of ABIONYX Pharma's industrial and regulatory program

• Confirmation of TEXCELL's international positioning in biopharmaceutical development

• Enhancement of synergies between the expertise of TEXCELL and ABL Diagnostics

WOIPPY, France--(BUSINESS WIRE)--Regulatory News:

ABL Diagnostics (Euronext Paris: ABLD - ISIN: FR001400AHX6), a company specializing in molecular diagnostic solutions, healthcare software and clinical research services, today announced the conclusion of a strategic partnership with ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible), a next-generation biopharmaceutical company developing innovative therapies in sepsis and intensive care, based on an exclusive apoA-I-based technology platform, with its TEXCELL division, an international reference in viral safety, viral clearance, biosafety and virology applied to biopharmaceutical development.

As part of this partnership, TEXCELL will carry out the safety and viral clearance studies associated with the preparation of validation batches for the manufacturing process of CER-001, a biologic drug candidate developed by ABIONYX Pharma in several indications, including LCAT deficiency.

Recognition of TEXCELL's scientific and regulatory expertise

Viral safety studies are an essential step in the development and industrialization of biological drugs. They aim to demonstrate the ability of manufacturing processes to eliminate or inactivate possible viral contaminants in accordance with the expectations of international regulatory authorities.

The choice of ABL Diagnostics' TEXCELL division by ABIONYX Pharma confirms the recognition of its scientific expertise and technological platforms among innovative players in the biopharmaceutical sector. The solutions developed by TEXCELL meet the scientific, quality and regulatory standards required for the main global markets, particularly in Europe, the United States and Asia.

A strengthened platform since the integration into ABL Diagnostics

Since its integration into ABL Diagnostics, the TEXCELL division has benefited from an expanded scientific environment combining expertise in viral safety, molecular diagnostics, microbiology, virology, sequencing and genomic analysis.

This complementarity of know-how allows ABL Diagnostics to support its partners at all critical stages of the development of biological products, from biosafety studies to the most advanced phases of industrial and regulatory development.

The partnership announced today illustrates ABL Diagnostics' ability to provide its customers with a unique offer combining innovative technologies, regulatory expertise and high-level scientific know-how.

Sustained momentum in biopharma activities

This new collaboration is fully in line with ABL Diagnostics' development strategy aimed at strengthening its position in high value-added services related to the development of biological products.

Through its TEXCELL division, ABL Diagnostics now supports a growing number of international biotechnology and biopharmaceutical companies in their development projects, with services covering biosafety, viral safety, viral clearance and the specialized studies necessary to obtain regulatory approvals.

"We thank ABIONYX Pharma for its trust. The choice of TEXCELL to support this strategic step in the development of CER-001 illustrates the international recognition of our expertise in safety and viral clearance," said Dr. Chalom Sayada, Chief Executive Officer of ABL Diagnostics. "Thanks to the combination of the know-how of TEXCELL and ABL Diagnostics, we are able to provide our biopharmaceutical partners with first-rate scientific and regulatory support, meeting the highest requirements of international health authorities."

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.

Following the acquisition of TEXCELL’s operations, ABL Diagnostics is expanding its activities in the life sciences sector by integrating expertise and services dedicated to virology, biosafety testing and biopharmaceutical development support.

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.

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.