Merck Becomes Sole Testing Provider for Genetix Biotherapeutics’ FDA-Approved Gene Therapies

Darmstadt, Germany, May 07, 2026 (GLOBE NEWSWIRE) --

• Merck enters five-year agreement to provide end-to-end testing services for Genetix Biotherapeutics’ commercial therapies
• Partnership builds on more than a decade of collaboration, reinforcing Merck’s role in supporting the safe, reliable commercialization of novel modalities

Merck, a leading science and technology company, today announced a five-year agreement with Genetix Biotherapeutics to provide analytical and biosafety release testing services for its portfolio of FDA-approved gene therapies.

The agreement covers three FDA-approved gene therapies developed by Genetix to treat sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. These therapies are designed as one-time treatments that target the underlying causes of serious, life-limiting rare diseases.

“As cell and gene therapies continue to move into commercial use as treatments for devastating diseases, this agreement underscores the critical role our high-quality BioReliance^® analytical and biosafety testing plays,” said Paolo Carli, Head of Advanced Solutions for the Life Science business of Merck. “With more than 75 years of specialized expertise in these areas, we are the innovation partner for customers at their most complex points in the development and commercialization of novel modalities.”

“At Genetix Biotherapeutics, we are focused on scaling our commercial operations to expand access to our transformative genetic therapies as demand continues to grow”, said Brian Riley, President and Chief Technical Officer. “That requires a testing partner with deep technical expertise, proven commercial-scale execution and broad geographical reach. Beyond capabilities, sharing a patient-centric mindset makes the Life Science business of Merck a natural fit as we work together to deliver one-time curative therapies reliably and consistently to patients who need them most.”

The partnership builds on more than a decade of collaboration between Merck and Genetix, including the joint development and validation of specialized test methods to support the release and commercialization of advanced therapies. Merck’s end-to-end testing services for novel modalities include analytical and bioassay testing, biosafety testing, viral clearance studies and cell banking services, helping customers meet development and release requirements while supporting the safety, consistency and reliability of their therapies.

From established biologics to novel modalities, customers need deep scientific expertise, integrated capabilities and reliable testing infrastructure to move from development to commercialization with confidence. Merck’s commitment to advancing testing innovation is reflected in the continuous expansion of its BioReliance^® portfolio, which includes next-generation testing platforms such as Blazar^® for rapid virus detection and Aptegra®, an all-in-one, validated genetic stability assay.

About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2025, Merck generated sales of € 21.1 billion in 65 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

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• Merck: Sole Testing Provider for Genetix Biotherapeutics' Gene Therapies

Jenny Wuestner Merck +4915114543158 jenny.wuestner@merckgroup.com