Pluslife Advances Global TB Testing Innovation and Expands Development of Drug-Resistant TB Products
In a remote village in Indonesia, 40-year-old Ravi has been suffering from persistent chest pain, coughing, and low fever for over a month. He visited the local health center, where the doctor could only rely on traditional acid-fast bacillus smear tests to diagnose tuberculosis (TB). However, smear microscopy has low diagnostic sensitivity, which often leads to misdiagnosis, potentially worsening Ravi's condition during the delay.
If the doctor had chosen to use more advanced molecular testing technologies, they would have needed to send the sputum sample to a laboratory in a major city hundreds of kilometers away, incurring high testing costs.
Although molecular diagnostic technologies like GeneXpert offer faster and more accurate TB testing methods, their high cost and technical requirements limit their availability in some regions. Providing a fast, reliable, and affordable testing tool for patients like Ravi has become an urgent challenge.
This is not an isolated case. According to the 2024 Global Tuberculosis Report, TB remains a significant public health challenge worldwide. In 2023, an estimated 10.8 million people developed TB, with 55% being male, 33% female, and 12% children and adolescents. TB is prevalent across all countries and age groups, with a heavy burden. Furthermore, 1.25 million people died of TB globally in 2023, including 161,000 HIV-infected individuals—TB may now be the leading cause of death from infectious diseases worldwide. TB is also a leading cause of death among HIV patients and a major contributor to antimicrobial resistance-related deaths.
The growing resistance of Mycobacterium tuberculosis (MTB) to TB drugs, especially rifampin (RIF), is intensifying the difficulty in treatment and control.
Current diagnostic methods like sputum smear microscopy and culture still face issues of slow speed and the need for complex laboratory equipment, which is often lacking in low- and middle-income countries (LMICs). Molecular diagnostic technologies, such as GeneXpert, are accurate and effective but are expensive and require specialized personnel and stable power supply, limiting their use in primary healthcare institutions in these regions.
The challenge lies in designing an easy-to-use and cost-effective molecular diagnostic tool to meet the needs of low- and middle-income countries. Pluslife is continuously working to address this challenge.
Pluslife has developed a new isothermal amplification technology—its proprietary RHAM isothermal amplification system. The unique probe reporting system enhances the signal from specific amplification products, making it superior to traditional isothermal amplification systems. By optimizing reagent formulations and leveraging the advantages of large-scale production, Pluslife is promoting a new generation of molecular POCT (Point-of-Care Testing) tools specifically for detecting Mycobacterium tuberculosis (MTB) and drug-resistant tuberculosis (MDR-TB), addressing the urgent need for effective diagnostic tools in low- and middle-income countries. This project aims to provide cost-efficient, easy-to-use testing solutions to shorten diagnostic time and address the lack of laboratory infrastructure in these regions. This innovative tool will aid in early TB diagnosis and timely treatment in resource-limited settings.
Pluslife hopes to bring this testing tool to more places in need, especially in low- and middle-income countries, helping more people access timely TB diagnoses.
Innovation Breakthrough: Fast, Accurate, Accessible, Cost-efficient Tongue Swab Testing
At a clinic in South Africa, 48-year-old Carol, a long-term HIV patient, visits with persistent coughing and weight loss. The doctor suspects she has tuberculosis (TB), but is unsure how to test her. Research shows that up to a third of HIV patients may not be able to provide sufficient sputum samples for testing, a situation especially common in severely immunocompromised patients.
According to studies from BMJ Open and the World Health Organization's 2021 Global Tuberculosis Report, in 2020, only 59% of 5.8 million newly diagnosed TB cases were confirmed by bacteriological tests (like sputum testing). This means nearly half of patients cannot be diagnosed using traditional sputum-based methods because they cannot cough up sufficient sputum. This problem is especially prevalent in children, the elderly, and the immunocompromised, making it a significant challenge in TB diagnosis. HIV patients may face similar difficulties, particularly those with severely compromised immune systems who cannot effectively produce enough sputum for accurate TB testing.
In situations where testing conditions are inadequate or patients cannot provide samples, the need for alternative solutions is urgent. Tongue swab sampling and rapid molecular diagnostic technologies (such as the WHO-recommended rapid nucleic acid amplification test) are gradually being promoted, and Pluslife's tongue swab testing solution offers a fresh approach to this issue.
Pluslife's innovative TB tongue swab testing solution provides significant advantages in speed, cost, and accuracy. The test can provide TB diagnosis results from simple tongue swabs or sputum samples in just 5-25 minutes, after a brief preparation time. Compared to traditional TB testing methods, Pluslife's technology drastically shortens testing times and offers an on-site solution, making it highly suitable for resource-limited areas.
Pluslife's TB (tongue swab) rapid molecular diagnostic kit received an import medical device license from the Indonesian government in August of this year, making Pluslife the first company in Indonesia to receive certification for a dual-sample (sputum and tongue swab) TB detection technology.
Additionally, recent data released at the 55th World Conference on Lung Health showed that Pluslife's TB testing products surpassed the World Health Organization's requirements for "near POC non-sputum diagnostic," demonstrating exceptional performance.
For patients like Carol, Pluslife's TB tongue swab testing solution offers significant help. This non-sputum sample test overcomes the sputum shortage problem, providing fast, accurate, on-site TB diagnosis. This method is particularly important for TB detection in the elderly, children, and HIV patients, as rapid diagnosis can significantly reduce diagnostic delays, enabling early treatment and improving outcomes.
This solution offers two key advantages, greatly enhancing the accessibility of TB testing. First, in terms of platform performance, Pluslife's testing devices are fast, cost-efficient, and accurate, making them suitable for deployment in resource-limited settings. This allows remote areas or primary healthcare institutions to offer high-quality TB diagnostic services at lower costs, significantly lowering technical and economic barriers and enabling more patients to access affordable medical support.
Second, the sample collection process is simple, requiring only a tongue swab, making it crucial for patients like Carol who cannot provide sputum samples due to their health conditions, as well as for children, the elderly, and others who struggle to cough up sputum. This simplified sampling method not only makes the testing process easier and more patient-friendly but also greatly expands diagnostic coverage, enabling more patients to be identified and diagnosed in time, advancing the universal and efficient TB testing initiative globally.
Decentralized TB Tongue Swab Testing: Enabling Active Case Finding in High-Burden Regions
Pluslife's TB molecular diagnostic products meet the World Health Organization's definition of a "near POC non-sputum diagnostic," meaning the platform can resolve diagnostic challenges for patients who cannot provide sputum samples using simple tongue swab sampling, significantly reducing diagnostic and treatment wait times. Patients can begin treatment sooner. Moreover, this simplified process allows more asymptomatic or active patients to receive timely screening and diagnosis.
Additionally, because the equipment requires minimal environmental conditions, Pluslife's TB testing solution is highly suitable for use in primary healthcare settings. Unlike traditional methods that require samples to be sent to laboratories, Pluslife's tongue swab test cards can be used directly at primary healthcare points, saving time and costs, and providing feasible solutions for high-burden areas. Through this TB testing solution, Pluslife not only improves diagnostic efficiency but also actively promotes the implementation of Active Case Finding (ACF). ACF is a strategy of proactively reaching out to potential patients for early testing, especially in high TB-burden areas. It effectively identifies active infections or patients who have not sought medical care, preventing the spread of TB and reducing the disease burden.
Active Case Finding has profound public health significance in TB control, particularly in resource-poor areas. Early detection and timely treatment of TB are critical to reducing its transmission, but in low- and middle-income countries, diagnostic rates remain low due to difficulty in sample collection and scarce diagnostic resources. By using Pluslife's TB tongue swab testing solution for ACF, it is possible to identify potential TB patients who cannot provide sputum samples, ensuring early diagnosis and treatment to slow disease transmission.
Furthermore, this initiative helps promote healthcare equity, ensuring that vulnerable groups (such as children, the elderly, and HIV patients) have access to diagnostic opportunities, narrowing the healthcare gap between high-income and low- and middle-income regions. Early detection and treatment help reduce later treatment costs and prevent impoverishment due to illness.
Staying true to its mission of “Revolutionizing and Decentralizing Infectious Disease Diagnosis with Innovative, Rapid, Accurate, and Affordable Molecular POCT Solutions,” Pluslife is dedicated to providing affordable and rapid testing solutions for areas with limited resources. From a global perspective, enhancing testing capabilities is also a critical part of achieving the 2030 Sustainable Development Goals and supports the global goal of ending tuberculosis.
Gates Foundation Supports Pluslife in WHO Prequalification Application, Advancing TB Control in Low- and Middle-Income Countries
Pluslife's tuberculosis (TB) diagnostic solutions are progressing toward achieving prequalification by the World Health Organization (WHO). In this endeavor, Pluslife's molecular diagnostic products for TB have received funding support from the Bill & Melinda Gates Foundation. The Gates Foundation is committed to promoting global health, particularly in low- and middle-income countries, ensuring the availability of low-cost, high-performance TB diagnostic tools.
This collaboration follows the signing of an agreement with the Gates Foundation in July on a precision diagnostic project for sexually transmitted infections (STIs). It marks another milestone in Pluslife's expanding partnerships in the healthcare sector.
The mission and vision of Pluslife align closely with those of the Gates Foundation. We sincerely thank the Gates Foundation for its generous support of our TB diagnostic project. Through this initiative, Pluslife aims to accelerate the adoption of TB diagnostic solutions in high-burden regions, advancing global TB control efforts toward greater sustainability. Together, we strive for a win-win partnership in the fight against TB.
Pluslifes Comprehensive TB and Drug Resistance Solutions: Enhancing Accessibility
To build an integrated TB diagnostic solution, Pluslife is also fast-tracking the development of drug-resistant TB detection cards. This holistic diagnostic approach will significantly enhance diagnostic efficiency, providing comprehensive and rapid testing support for resource-limited regions and enabling patients to receive timely treatment.
In low- and middle-income areas, where healthcare resources are often insufficient, patients typically face a complex and time-consuming process of sending samples to urban laboratories. Pluslife's comprehensive TB diagnostic solution simplifies this process, enabling dual diagnostics for TB and drug resistance, expediting treatment, and preventing disease progression and transmission.
Pluslifes Global Vision and Future Plans
In TB diagnostics, Pluslife will continue to drive innovation by exploring diverse sample types and testing scenarios, refining product performance to meet the varying needs of different regions and populations. The company plans to increase investments in research and development, production, and global supply chains to build a more resilient and inclusive public health ecosystem.
Our goal is to contribute to the global fight for zero TB prevalence, ensuring that patients in the most underserved regions receive timely diagnosis and treatment regardless of economic or accessibility barriers. By making TB control feasible, Pluslife aspires to support the broader vision of global health equity.
Ravi and Carol may seem distant to us, but their stories reflect the plight of thousands of patients worldwide. Through innovative technology and proactive screening strategies, this initiative can save lives, curb TB's spread, and provide tangible support for global public health improvement.
