Is gene therapy safety regulation keeping pace with the science? The FDA's recent draft guidance on the safety assessment of genome editing products is an important milestone. Its emphasis on next-generation sequencing, long-read sequencing and robust genomic analysis reflects the remarkable advances that have transformed our ability to detect unintended genomic alterations. But the science has already moved further. In a comment submitted by us at TestAVec and Brunel Univers

On 13 May 2026, The New England Journal of Medicine published a case report describing what appears to be the first documented human cancer associated with AAV-mediated gene therapy. The patient, a boy with severe mucopolysaccharidosis type I (Hurler syndrome), received an AAV9 vector carrying the IDUA gene at 13 months of age. The treatment successfully preserved cognitive function, but four years later routine MRI imaging detected a brain tumour that was subsequently remove

TestaVec was proud to sponsor the annual conference of the British Society for Gene and Cell Therapy, held this year in Newcastle. Representing the company were CSO Mike Themis, Associate Scientist Hassan Abdulrazzak, and Principal Scientific Officer Saqlain Suleman. The conference proved to be highly engaging, offering valuable opportunities for discussion with a wide range of scientists from both academia and industry. These conversations highlighted the continued momentum

Gene therapy offers hope for treating rare genetic diseases with potentially one-time, long-lasting solutions. Yet, the path to safe and effective gene therapies has faced challenges, especially due to serious side effects linked to the viral vectors used to deliver therapeutic genes. The FDA’s new regulatory roadmap, introduced in late 2025, aims to address these challenges and accelerate the approval of gene therapies for rare diseases, particularly those that are life-thre

Our paper highlighted the transcriptomics of the induced pluripotent stem cells and liver derivatives has been selected as the Editor's choice article. This paper titled " 𝗧𝗿𝗮𝗻𝘀𝗰𝗿𝗶𝗽𝘁𝗼𝗺𝗶𝗰 𝗣𝗿𝗼𝗳𝗶𝗹𝗶𝗻𝗴 𝗼𝗳 𝗶𝗣𝗦 𝗖𝗲𝗹𝗹-𝗗𝗲𝗿𝗶𝘃𝗲𝗱 𝗛𝗲𝗽𝗮𝘁𝗼𝗰𝘆𝘁𝗲-𝗹𝗶𝗸𝗲 𝗖𝗲𝗹𝗹𝘀 𝗥𝗲𝘃𝗲𝗮𝗹𝘀 𝗧𝗵𝗲𝗶𝗿 𝗖𝗹𝗼𝘀𝗲 𝗦𝗶𝗺𝗶𝗹𝗮𝗿𝗶𝘁𝘆 𝘁𝗼 𝗣𝗿𝗶𝗺𝗮𝗿𝘆 𝗟𝗶𝘃𝗲𝗿 𝗛𝗲𝗽𝗮𝘁𝗼𝗰𝘆𝘁𝗲𝘀" compares the profile of the cells we use in the TestAVec laboratories