USM Develops Local Diagnostic Product Prototypes

GEORGE TOWN, Aug 19 (Bernama) -- 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 said the institute currently has several products and prototypes in the development pipeline with commercialisation potential, including through the establishment of a spin-off company.

She said 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.

“Currently, we have several products and prototypes developed by lecturers and researchers in the pipeline, and we plan to start with one flagship product before moving on to the 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),” she said when met by reporters after the 8th International Conference on Molecular Diagnostics and Biomarker Discovery (MDBD) here today.

The two-day conference, which ends tomorrow, is organised by INFORMM USM in collaboration with its sole sponsor, Thermo Fisher Scientific, and brings together about 150 scientists, healthcare practitioners, researchers, policymakers and industry representatives from Malaysia and abroad.

Held under the theme ‘Redefining Healthcare: Multi-Omics Driven Diagnostics and Therapeutics’, MDBD 2026 focuses on the use of emerging technologies to improve diagnostic accuracy, targeted treatment and personalised healthcare.

Aziah said one of the main challenges in bringing research-based diagnostic products to market is the time required to meet regulatory requirements, particularly as the products are categorised as in vitro diagnostics (IVD), which are a type of medical device.

She said IVD products must undergo documentation, preparation and audit processes to obtain ISO 13485 certification before they can be submitted to MDA for the next stage.

“For other products being commercialised, the regulatory process may not be as lengthy, but diagnostic or IVD products must undergo ISO 13485 certification and MDA approval before they can be used. Therefore, the main constraint is time, as the documentation, preparation, audit and certification processes are all required,” she said.

-- BERNAMA