KUALA LUMPUR, July 2026 — As Malaysia confronts a significant surge in Tuberculosis (TB) cases, with over 3,100 confirmed infections recorded in the first two months of 2026 alone, Medical Innovation Ventures Sdn. Bhd. (Mediven®) announced that the Pluslife MiniDock MTB Test is now an MDA-registered medical device under the Medical Device Authority (MDA). This landmark approval introduces a World Health Organization (WHO) recommended, “first-in-class” molecular diagnostic tool to the Malaysian market. The system is specifically designed to decentralize TB detection and accelerate treatment in community settings, prisons, and rural hotspots, directly addressing the limitations of traditional laboratory infrastructure.
The urgency of this rollout is underscored by recent government observations regarding the national TB burden. During recent public health briefings, officials noted that TB remains a top priority for the Ministry of Health, particularly as Epidemiological Week 6 data showed a 10% increase in notifications compared to the previous year, with nearly 600 new infections detected per week. Clusters are increasingly concentrated in dense urban areas and remote rural regions, necessitating a shift toward “test and treat” models. The Pluslife MiniDock provides the technological bridge for this transition; its portability allows for deployment in rural clinics where centralised testing is inaccessible, while its 30-minute turnaround time ensures that urban patients are diagnosed and linked to care within a single visit, consistent with the latest international standards for infectious disease control.
In March 2026 WHO Policy Update, WHO describes Pluslife MiniDock as the first-in-class near-of-care nucleic acid amplification test (nPOC-NAAT) for the initial detection of TB. This low-complexity, portable molecular diagnostic test is designed for use by professionals or trained personnel in decentralized, peripheral health settings, such as primary healthcare centers. Its technical design allows for molecular testing to be performed at the point of care, providing access to diagnostic results in locations with limited or no centralized laboratory infrastructure.
Professor Norazmi Mohd Nor, Professor of Molecular Immunology, School of Health Sciences, University Sains Malaysia, emphasised the importance of this shift:
“Tuberculosis control hinges on early and accurate detection. Rapid molecular diagnostics such as the Pluslife MiniDock MTB Test may complement existing diagnostic approaches. Tools like this enable us to detect infections earlier, including in asymptomatic or difficult-to-diagnose patients, which is critical for breaking transmission chains in endemic settings in Malaysia.”
Dr. Muhammad Nazri bin Aziz, Consultant Medical Microbiologist and Pathologist at Lablink Bhd., further highlighted the operational advantages of decentralised testing:
“From a laboratory and diagnostics network perspective, decentralised molecular testing is a game changer. It reduces dependency on central lab infrastructure such as smear microscopy, while maintaining diagnostic accuracy of 100% specificity and 77–78% sensitivity. More importantly, it allows clinicians to make immediate decisions, which is critical in infectious diseases like TB where every delay increases transmission risk.”
A major innovation highlighted by the WHO and integrated into the Pluslife MiniDock system is the use of tongue swabs. This painless, non-invasive method allows samples to be collected from the surface of the tongue for molecular testing, providing a diagnostic option for individuals aged 12 years and older who may have difficulty producing sputum. While sputum is the primary sample for initial detection, tongue swabs provide an alternative diagnostic option in decentralized healthcare settings, such as peripheral laboratories and primary clinics. This platform is intended for use by trained personnel to facilitate molecular TB testing by trained users in locations with limited laboratory infrastructure. The Pluslife MiniDock System is already implemented in 12 countries globally.
The necessity for heightened public participation in these screening efforts was recently emphasised by Dr. Ismuni bin Bohari, Deputy Director-General of Health (Public Health). While noting that the national infection status has remained stable at approximately 61 to 80 cases per 100,000, Dr. Ismuni cautioned against public complacency, urging individuals to remain vigilant and seek early TB screening to prevent further community transmission. This vigilance is especially critical in congregate settings like correctional facilities, dormitories etc., where transmission risks are among the highest.
The latest Ministry of Health data for 2026 also reveals a sobering reality: 85% of all TB cases in Malaysia involve local citizens (Ahmad, 2026). This statistic underscores that the disease has transitioned from isolated clusters in congregate worker settings to a broader community health challenge, necessitating the widespread deployment of rapid molecular tools to safeguard the public.
Expanding on these systemic risks, Azrul Mohd Khalib, CEO of the Galen Centre for Health and Social Policy, recently drew parallels between the current rapid community spread and the early stages of the COVID-19 pandemic, noting active clusters in workplaces, factories, and dormitories. To address the requirements of these environments, the Pluslife MiniDock MTB Test features a portable design intended for use in near-point-of-care (nPOC) settings by trained users. This technical capability facilitates molecular testing with a turnaround time of less than 30 minutes at the point of care. By providing a high-sensitivity alternative to conventional microscopy, the device enables trained users to generate molecular results within 30 minutes, a rapid sample-to-result capability that supports initial TB detection in settings identified by the Ministry of Health as high-burden areas.
Visiting Infectious Diseases Consultant at University Malaysia Sabah (UMS) and former Deputy Director-General of Health at Ministry of Health, Datuk Dr. Christopher Lee, underscored the broader public health impact:
“Timely diagnosis remains important in TB management. Deploying rapid molecular diagnostics at the point of care may support timely diagnostic workflows when used by trained users and interpreted with clinical and laboratory findings.”
The approval of this breakthrough technology is viewed as a vital component of Malaysia’s broader mission to eradicate TB by 2035. With the Pluslife MiniDock MTB Test registered with MDA, Mediven® provides a near-point-of-care (nPOC) molecular platform for use by trained users in decentralized healthcare settings. This is a critical step in reaching the national goal of ending TB.
About Mediven®
Medical Innovation Ventures Sdn. Bhd. (Mediven®) is a Malaysian diagnostics company that develops, manufactures, and distributes molecular and rapid diagnostic solutions. As an authorised distributor of Pluslife System, Mediven® is committed to supply the MDA-registered Pluslife MiniDock MTB Test to the Malaysian healthcare market as an aid in the diagnosis of pulmonary TB.
About Pluslife Biotech
Pluslife Biotech is a biotechnology company that specializes in the development and manufacturing of isothermal molecular point-of-care (POC) diagnostic systems. Its MiniDock MTB system is recognised by the WHO as a ‘first-in-class’ solution for decentralised TB detection, enabling rapid and accurate diagnosis in any environment.
References:
- Ministry of Health (2026). Tuberculosis Situational Report: Epidemiological Week 6, 2026. Putrajaya: Disease Control Division (Tuberculosis/Leprosy Sector) University Sains Malaysia (USM) Medical Microbiology & Immunology Faculty Perspectives, 2026.
- Ministry of Health (2026). Health Sector Assessment of Congregate Settings. Putrajaya.
- Bernama / Malay (2026). TB cases stable in Malaysia at 61–80 per 100,000 population, but public urged not to be complacent. Published February 25, 2026.
- Ahmad, S. D. (2026, February 18). Ministerial Statement on Tuberculosis Demographic Data in Malaysia. Ministry of Health Malaysia.
- Code Blue / Galen (2026). Galen Centre Gets Covid Deja Vu with Nationwide TB Epidemic. Published February 16, 2026.
- Malaysian Infectious Diseases Expert Consensus Forum, 2026.
- Guideline: WHO Consolidated Guidelines on Tuberculosis, Module 3: Diagnosis (2024).
- Handbook: WHO Operational Handbook on Tuberculosis, Module 3: Diagnosis (2024/2026 Update).
- Lablink (M) Sdn Bhd Diagnostic Ecosystem Report, 2026.
Registered under Act 737
IVDA10491026-223305 ; IVDC8711226-229135
MDAMD172/2026
