NEW vaccines and novel drugs often dominate headlines, but affordable diagnostics – the quieter sibling of medical innovation – brings universal health coverage to the remotest clinics. Affordable tests enable earlier detection, faster treatment and better outcomes. For rural patients, timely diagnostics can mean the difference between life and death. Or financial stability versus catastrophic health expenditure. Yet, in low- and middle-income countries, where needs are greatest, high-quality diagnostics remain scarce.
The future of diagnostics
Better, more accessible diagnostics will be vital to Malaysia's healthcare in the next decade. Diagnostics lag as the weakest link in the health system: 47% of the global population lacks basic diagnostics. The Universiti Malaya Affordable Diagnostics and Therapeutics (UMADT) programme, a member of the International Affordable Diagnostics and Therapeutics Alliance (IA-DATA), has developed a blueprint to transform this. With this, Malaysia aims to become a high-impact diagnostics hub for Asean's 700 million population, partnering with the Ministry of Health Malaysia and Universiti Malaysia Sarawak (UNIMAS).
Prototype-to-patient bridge
MyLiSA, Universiti Malaya's ISO13485-accredited facility, bridges the research-to-adoption gap building manufacturability into its design and linking small-batch production with clinical need. It guides UMADT tech through validation and regulation for Malaysian rollout, enabling local design, testing and scaling.
National ecosystem support
The New Industrial Masterplan 2030 (NIMP 2030) and Medical Device Authority (MDA) bolster this ambition through targeted medtech reforms. NIMP 2030 designates medical devices a strategic sector. The Masterplan emphasises high-value manufacturing and university-government-industry links to speed development, testing and compliance. This pathway turns prototypes into competitive products via incentives for innovation and exports. MDA, under the 2012 Medical Device Authority Act, ensures safety and efficacy through licensing, registration and conformity assessments, balancing protection with trade. MDA is also working on building regional and Global South reliance through close collaboration with other Asean countries as well as China and Gulf Cooperative Countries (GCC). For innovators like UMADT and MyLiSA, appropriately abridged reviews for reference-market approvals cut time-to-market, cementing Malaysia's Asean hub status.
Clinical Research Malaysia (CRM), a Health Ministry entity since 2012, accelerates trials by identifying site capabilities and fast approvals and support. CRM success has drawn RM1bil FDI, mainly from the pharmaceutical sector thanks to access to ethnically diverse populations, a skilled research workforce and cost-efficiency. Malaysia is now recognised as a leading destination for early phase trials, with a diverse case mix of non-communicable and infectious diseases, genetically diverse population, highly trained research personnel and streamlined regulatory pathways major pull factors. Although pharmaceutical trials currently make up the majority of sponsored research studies, CRM is poised to consolidate the evidence base for diagnostics development via multi-centre studies, thereby boosting health tech investment.
Enhancing accessibility
These innovations are crucial in the challenges Malaysia faces with endemic infections like dengue, malaria, leptospirosis and melioidosis. Their diagnostic gaps are worsened by urban-rural divides. In Sabah and Sarawak, half the population lives hours from hospitals, facing undifferentiated fevers with overlapping symptoms that demand multiple tests, delaying care and raising costs.
UMADT is partnering with Sansure Biotech Inc. on point-of-care molecular tests: a dengue-specific test and a "4-in-1" test for dengue, Plasmodium knowlesi ("monkey malaria"), leptospirosis and melioidosis from one sample. The backpack-portable (10kg) platform delivers results in 30-45 minutes for multiple samples. Validation studies will be delivered in collaboration with Ministry of Health and University Malaysia Sarawak (UNIMAS). This solution is scalable for other Asean countries facing similar epidemiological and geographic challenges.
UMADT is also validating a novel lateral flow test for urinary tract infections (UTIs) with the Ministry of Health and Global Access Diagnostics (GADx, UK). UTIs risk sepsis; current options – slow cultures (48 hours) or nonspecific dipsticks – fuel antibiotic overuse. This instrument-free, 5-minute test detects immune signals for precise point-of-care use in rural clinics, curbing antibiotic resistance risks.
Regional hub vision
These initiatives are not isolated projects. Together, they sit within a broader Malaysian effort to build an affordable diagnostics hub capable of producing low-cost, high quality tests locally for use across the region. The 4-in-1 febrile illness test and the rapid UTI test are early exemplars of what a coordinated ecosystem – linking UMADT, MyLiSA, the NIMP 2030 industrial agenda, the MDA's regulatory framework and CRM's clinical trial platform – can deliver.
With non-communicable and infectious disease burdens both rising, affordable and smarter diagnostics will be central to safeguarding population health. This aligns with both Malaysia's Health White Paper for preventive primary care and the vision and mission of the IA-DATA. Affordable, accessible diagnostic tools – developed, validated and manufactured within Malaysia's own ecosystem – will be essential to making that vision a reality for communities from Kuala Lumpur to the most remote longhouses in Borneo and across Asean.
About the Authors
Professor Sanjeev Krishna is Em Professor of Medicine and Molecular Parasitology and a Visiting Professor at Universiti Malaya. He is also the Director for the South-South Diagnostic Alliance, a project under the umbrella of the International Affordable Diagnostics and Therapeutics Alliance.
Dr Ivy Chung is a Professor of Pharmacology based at the Faculty of Medicine, Universiti Malaya. She is the lead Principal Investigator for the Universiti Malaya Affordable Diagnostics and Therapeutics program, a project under the umbrella of the International Affordable Diagnostics and Therapeutics Alliance.
Dr Yolanda Augustin is a Clinical Oncologist at City St George's University of London and a Honorary Visiting Lecturer at Universiti Malaya and Universiti Malaysia Sarawak. She is a lead co-ordinator of the International Affordable Diagnostics and Therapeutics Alliance.
