InnoWave DX's Novel IP-10.TB™ Assay Receives Approval: A Global First for Fully Automated, Rapid Tuberculosis Immune Response Testing
In April 2020, Suzhou Chuanglan Biotechnology’s kit for detecting Mycobacterium tuberculosis-specific cellular immune responses (IP-10.TB™) was approved for market launch, marking the world’s first approved kit of its kind based on the IP-10 mRNA target.
After five years of independent development, the IP-10.TB™ assay, launched alongside a fully automated system for nucleic acid extraction and reaction setup, provides a convenient, rapid, precise, and efficient new solution for diagnosing suspected tuberculosis cases and conducting TB screening. Its market introduction may fill the gap in the field of TB-specific cellular immune response testing, which currently lacks fully automated, rapid diagnostic products, marking a significant breakthrough in China’s tuberculosis diagnostic capabilities.
In a clinical study involving over 1,000 cases conducted by a renowned domestic tuberculosis clinical institution, the IP-10.TB™ assay was completed within hours after whole blood sample collection, significantly reducing the turnaround time for this type of testing. The study data demonstrated that the clinical sensitivity of IP-10.TB™ exceeded 90%, with detection rates of 92% for smear-positive pulmonary tuberculosis cases, 90% for smear-negative pulmonary tuberculosis cases, and 90% for extrapulmonary tuberculosis cases. Meanwhile, the test achieved a negative rate of 99% among individuals at low risk for tuberculosis who were PPD-negative and had normal chest radiographs. These findings indicate that IP-10.TB™ holds substantial reference value for the rapid differential diagnosis of tuberculosis, particularly for forms such as smear-negative tuberculosis where bacteriological evidence is difficult to obtain, thereby offering new possibilities for optimizing tuberculosis diagnosis and treatment strategies.
Tuberculosis is a very ancient disease. In 1882, the German scientist Robert Koch identified Mycobacterium tuberculosis as the pathogen causing tuberculosis. This bacterium can invade multiple organs in the human body, including the brain, gastrointestinal tract, pericardium, pelvic cavity, bones, peritoneum, and lymph nodes. Tuberculosis is also one of the top 10 causes of death worldwide.
According to World Health Organization estimates, approximately one-quarter of the global population is currently infected with Mycobacterium tuberculosis and faces the risk of progressing to active tuberculosis. In 2018, there were an estimated 10 million new cases of tuberculosis worldwide, and nearly 1.491 million people died from the disease. In 2016, the World Health Organization set forth the goal of ending the global tuberculosis epidemic by 2035 and eliminating tuberculosis entirely by 2050.
Since the founding of the People's Republic of China, tuberculosis (TB) prevention and control have been highly prioritized. Starting in 2011, China implemented five-year special plans for TB control and gradually established a three-tiered TB prevention and control network spanning provincial, municipal, and county levels. This network relies on designated medical institutions, primary healthcare facilities, and centers for disease control and prevention as key pillars, providing free screening and routine treatment for TB patients. Although China has made significant progress in TB control, it remains a country with a high burden of the disease. There are currently approximately 5 to 6 million TB patients in China, with around 900,000 new cases reported annually, indicating that the situation for prevention and control remains severe.
Under the current diagnostic framework, inadequate diagnostic capacity and the limited number of reported detected cases have long been bottlenecks constraining the improvement of global tuberculosis (TB) prevention and control. In the diagnosis of pulmonary TB, sputum smear microscopy, with a positivity rate of less than 30%, remains widely used. The World Health Organization’s Global Tuberculosis Report 2019 shows that in 2018, 7 million new TB cases were notified globally, which is 30% lower than the estimated 10 million new cases based on countries’ TB prevention and control capacities, resulting in an inversion where the number of notified TB cases falls significantly short of the estimated burden.
Currently, tuberculosis (TB) diagnostics primarily include microbiological, biochemical, immunological, and molecular biological tests. IP-10.TB™ is a next-generation cellular immunodiagnostic product for tuberculosis.
The first-generation immunological test, the Tuberculin Skin Test (TST), was the earliest method used for diagnosing tuberculosis infection. Due to its simplicity and low cost, it has been widely employed in tuberculosis screening. China has explicitly mandated screening for close contacts of patients with infectious pulmonary tuberculosis. In 2013, the "Measures for the Administration of Tuberculosis Prevention and Control" were issued, expanding the scope of high-risk populations for tuberculosis screening and designating seven key groups—including faculty and staff at schools and childcare institutions, as well as newly enrolled students—as priority populations for screening. The "Action Plan to End Tuberculosis," released in 2019, also provided clear stipulations regarding the scope of tuberculosis screening. However, TST suffers from poor specificity due to cross-reactivity with the Bacille Calmette-Guérin (BCG) vaccine and non-tuberculous mycobacteria, limiting its broader utility in tuberculosis detection. The second-generation immunological test, the Interferon-Gamma Release Assay (IGRA), avoids cross-reactivity between antigens and BCG or non-tuberculous mycobacteria, thereby enhancing specificity. Nevertheless, IGRA involves extensive manual procedures, and existing products require prolonged sample incubation times (nearly 24 hours), making it difficult to apply to more widespread tuberculosis testing.
IP-10.TB™ utilizes real-time fluorescent PCR technology to detect IP-10 mRNA levels in whole blood samples in vitro, both before and after stimulation with tuberculosis-specific antigens, thereby determining whether the human body has mounted a TB-specific cellular immune response. By targeting transiently expressed, highly stable IP-10 mRNA, IP-10.TB™ not only delivers more accurate results but also simplifies the operational workflow and significantly reduces testing time, with results available within hours after sample collection. This will help improve the efficiency of tuberculosis diagnosis and screening. Furthermore, due to the rapid and highly stable expression of the target analyte, this convenient and efficient diagnostic product demonstrates promising clinical performance in effectively reducing background interference and in special populations, such as those with immunodeficiency.
In recent years, IP-10 has been extensively studied in basic research on human inflammation and is regarded as an ideal target for tuberculosis (TB) detection. However, due to the significant challenges in capturing IP-10 mRNA and the complexity of industrial-scale manufacturing processes, few TB diagnostic products based on IP-10 mRNA have been brought to market. The approval of IP-10.TB™ represents a major step forward in the commercialization of TB diagnostics targeting IP-10 worldwide.
It is understood that Chuanglan Bio, founded in 2015, comprises senior experts in clinical microbiology, proteogenomics, cellular and molecular biology, and bioinformatics, along with a professional market operations team. Driven by a profound understanding of customer needs and clinical value, the team has optimized product workflows and clinical performance through various technological breakthroughs and micro-innovations. This ensures the rapid amplification and precise capture of IP-10 mRNA in human whole blood, ultimately establishing a technical pathway for in vitro release of IP-10 mRNA and delivering stable, reliable diagnostic products.
Over the past five years since its inception, Chuanlan Bio has not only deeply cultivated and strategically positioned itself in the field of tuberculosis testing but also actively expanded into pathogen diagnostics for other infectious diseases, offering a series of advanced product solutions. VCBeat will continue to monitor Chuanlan Bio’s future developments.