Kuala lumpur: Several research prototypes developed by Universiti Sains Malaysia (USM) are being evaluated for the development of local diagnostic products capable of detecting diseases earlier and more accurately before being commercialised. USM Institute for Research in Molecular Medicine (INFORMM) director Associate Prof Dr Aziah Ismail stated that the institute currently has several products and prototypes in the development pipeline with commercialisation potential, including through the establishment of a spin-off company.
According to BERNAMA News Agency, several technologies developed by INFORMM researchers had previously been commercialised through technology licensing to companies, while current efforts are more focused on establishing a spin-off company to manage new products under development. Dr Aziah mentioned that several products and prototypes developed by lecturers and researchers are in the pipeline, with plans to start with one flagship product before moving on to others.
The new products are currently at the proof-of-concept stage and will subsequently undergo evaluation before moving on to ISO 13485 certification and approval by the Medical Device Authority (MDA). This was revealed during the 8th International Conference on Molecular Diagnostics and Biomarker Discovery (MDBD), organised by INFORMM USM in collaboration with Thermo Fisher Scientific. The conference brings together around 150 scientists, healthcare practitioners, researchers, policymakers, and industry representatives from Malaysia and abroad, focusing on the theme 'Redefining Healthcare: Multi-Omics Driven Diagnostics and Therapeutics'.
Aziah pointed out a significant challenge in bringing research-based diagnostic products to market is the time required to meet regulatory requirements. Since these products are categorised as in vitro diagnostics (IVD), they must undergo documentation, preparation, and audit processes to obtain ISO 13485 certification before submission to MDA for the next stage. Unlike other products, IVD products demand a longer regulatory process involving ISO 13485 certification and MDA approval before they can be used, making time the main constraint due to the extensive documentation, preparation, audit, and certification processes required.