January 20-22 2025, the World Health Organization organized its first workshop on in vitro diagnostics prequalification (IVD PQ) for Asian manufacturers in Jakarta, Indonesia. As a prominent TB IVD technology hatchery in China, Innovation Alliance on Tuberculosis Diagnosis and Treatment (Beijing) was invited to attend the workshop. As Asia pacific region, especially China has become the global hotspot for IVDs technological innovation, many of these technologies harbor great promise in the global disease burden alleviation efforts led by the WHO and various other UN agencies. In order to maximize the impact of this wave of IVD innovation in the Asia pacific. The WHO decided to raise the awareness of its Prequalification mechanism amongst the region’s IVD manufacturers by hosting this event in Jakarta, Indonesia. 

The WHO IVD PQ was established in 2010, its operations were coordinated by the dept of Essential Medicines and Health Products (the WHO, Geneva). The purpose of IVD PQ is to certify in vitro diagnostic products for certain high priority diseases (likes of tuberculosis, HIV, Malaria, HBV, HCV and STIs among others) to see if it is of sound quality, safety and meet the performance thresholds as well as operational characteristics that make it suitable for deployment in resource constraint high disease burden countries. Once an IVD product has been successfully certified by PQ. It is then qualified for participating the tendering of various UN agencies and for the collaborative registration process (CRP) by which a little less than 40 countries recognize PQ listing to expedite the IVD product's in-country registration process. Currently there are more than 120 IVD products that have successfully certified by WHO PQ.

Tuberculosis IVD PQ is the most recent addition. Q4 2022, the WHO Global TB Program (WHO GTP) decided to undergo a transition, from recommending TB IVD products (first in the class) through its guidelines to gradually incorporating all other TB IVD products of the existing testing classes into the PQ process. Now, there are eight TB nucleic acid amplification tests (TB NATs) at various stages of PQ assessment, with one product having already received PQ certification.

During the workshop, representatives from the Gates Foundation, the Global Funds, the PATH institute have all shared their thoughts on the importance of PQ if an IVD product sets its eyes on the global public health market, which is growing exponentially since the COVID-19 pandemic.

As a prominent TB IVD technology hatchery in China, Innovation Alliance has been closely collaborating with many of China’s major TB IVD innovators in early clinical performance validation and qualitative user experience studies. A number of these technologies have shown promise in meeting the WHO TPPs profiling ideal performance and operational characteristics for deployment in resource constraint high TB burden countries. With an extensive TB laboratory and clinical trial network, Innovation Alliance is striving to play a more prominent role in the entire vertical of TB IVD development and translation, specifically from high quality evidence generation at the up stream to performance validation and eventually to be a facilitator of overseas market shaping and development at the downstream. In addition, Innovation Alliance is open for all partnerships who are interested in TB IVD global market development.