Danda Bio's Therapeutic Drug Monitoring Chemiluminescence Solution Launches, Poised to Make Immunoassay the Mainstream TDM Technology

Therapeutic Drug Monitoring (TDM) is a core pillar supporting the personalization of dosing regimens in clinical practice, effectively enhancing the safety and efficacy of pharmacotherapy. In recent years, with the rapid development of precision medicine and the continuous emergence of clinical demands, therapeutic drug monitoring has entered a period of robust growth.

However, as clinical drug concentration monitoring in China is primarilyDominated by imported brands, the market also suffers from limited testing panels, prolonged turnaround times, high costs, and complex operations....and many other pain points. Currently, the average hospital procurement price for instruments from imported manufacturers exceeds RMB 1 million, yet they offer only a dozen or so test items, which falls far short of clinical needs. This limitation hinders the widespread adoption of therapeutic drug monitoring (TDM), resulting in unsatisfactory implementation of TDM in clinical practice, particularly in primary healthcare institutions.

Recently, Diagreat developedChemiluminescence Solution for Therapeutic Drug Monitoring Receives NMPA Registration Certificate and Successfully Launches on the Market.This solution adoptsAlkaline phosphatase-labeled chemiluminescence immunoassay technology enables fully automated, high-throughput testing with a sample-in-result-out workflow, offering advantages such as unattended operation, comprehensive quality control, and stable, reliable results.It effectively addresses challenges such as the operational complexity and high costs associated with drug concentration testing, thereby significantly promoting the clinical application of therapeutic drug monitoring.

Therapeutic drug monitoring technologies primarily fall into two categories: chromatographic analysis and immunoassay. Chromatographic analysis includes high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS), with the market dominated by imported brands. Immunoassay encompasses enzyme-multiplied immunoassay technique (EMIT), chemiluminescence (represented by Diagreat), and fluorescent immunochromatographic point-of-care testing (POCT) (exclusively offered by Diagreat).

Chromatographic analysis offers high specificity but is characterized by high costs, complex operations, and long detection times. Although it is not limited by the number of analytes, it requires in-house method development, which restricts its clinical application. Immunoassays provide rapid detection, a high degree of automation, and good specificity; however, they currently offer a limited menu of tests, and imported instruments are expensive.

Chromatographic analysis and immunoassay each have their own advantages. Dr. Zhang Wang, Marketing Director at Diagreat, stated: “From the perspective of their respective characteristics, in terms of applications in the field of drug concentration monitoring,”Chromatographic analysis is more research-oriented., which can assist departments in exploring and launching new testing projects without being constrained by the types of test kits available, thereby offering unique application value; however, it has a relatively high barrier to entry.Immunoassays represented by chemiluminescence are better suited to the clinical application needs for therapeutic drug monitoring.If the limitation of a limited number of testable analytes can be overcome, it will be a more promising methodology for therapeutic drug monitoring in the long run.”

Precisely because of the long-term advantages of immunoassays in the field of therapeutic drug monitoring (TDM), Diagreat has remained steadfast in its strategic focus on immunoassay-based TDM solutions, even as chromatographic analysis gains increasing popularity.

In response to the clinical demand for precision and efficiency in drug concentration monitoring, Diagreat has launched two drug concentration monitoring solutions based on chemiluminescence and immunochromatography.

First, the newly launchedChemiluminescence Solutions for Therapeutic Drug Monitoring, Primarily Designed for Clinical Laboratories and Pharmacy Departments in Grade A Tertiary Hospitals to Meet High-Precision Monitoring Requirements.

Currently, imported brands Siemens and Abbott have both established a presence in chemiluminescence products for therapeutic drug monitoring. Unlike Diagreat, both companies utilize acridinium ester-based direct chemiluminescence assays. This approach not only incurs higher costs but also suffers from a limited availability of reagent raw materials, resulting in a scarce portfolio of chemiluminescence assays for therapeutic drug monitoring. According to registration certificates listed on the National Medical Products Administration (NMPA) website, Siemens offers only 10 test parameters, while Abbott offers just 12.

Diagreat has innovatively adopted alkaline phosphatase-labeled chemiluminescence technology. Its chemiluminescence-based drug concentration detection solution enables fully automated, high-throughput testing with a "sample-in, result-out" workflow, offering advantages such as unattended operation, comprehensive quality control throughout the process, and stable, reliable results.It offers superior performance in terms of detection capabilities such as linear range.Most importantly,Diagreat has achieved full in-house research, development, and production of reagent raw materials, possessing the capability to continuously launch new testing assays, thereby effectively addressing the challenge of a limited test menu.

Secondly,POCT Solutions for Therapeutic Drug Monitoring: Addressing Timeliness Challenges in Clinical Departments of Tier-3 Hospitals and Laboratory/Pharmacy Departments of Lower-Tier Hospitals

Dr. Zhang Wang stated, “For certain medications with severe toxic side effects, the timeliness of testing is crucial. For instance, digoxin overdose can lead to serious arrhythmias, potentially endangering the patient’s life.” Timely drug concentration monitoring provides a scientific basis for clinical treatment. Diagreat offers point-of-care testing (POCT) solutions for drug concentration monitoring.Results are available within 15 minutes. Since its market launch in 2019, this solution has been deployed in nearly 200 tertiary hospitals across China.

Leveraging chemiluminescence and fluorescent immunochromatography, Diagreat has established a comprehensive portfolio in the therapeutic drug monitoring sector, catering to the diverse needs of hospitals at all levels.

Zhang Wang stated, “Specialization and standardization are the future development directions of the therapeutic drug monitoring market.” To this end, Diagreat has proposed three major research directions from the perspectives of technology development, standardized laboratory construction, and artificial intelligence.

First, we remain committed to the development of therapeutic drug monitoring (TDM) technologies, ensuring both a comprehensive product portfolio and distinctive features, thereby providing clinicians with a full spectrum of specialized testing services.And by continuously improving detection speed, sensitivity, and accuracy while reducing costs, it provides timely and precise data feedback for clinical practice, simultaneously lowering testing expenses for patients. “Currently, the 36 reagent products planned by Diagreat will be launched to the market successively within three years. By the end of this year, the company’s number of test items will reach 19,Become the supplier of therapeutic drug monitoring products with the most comprehensive test menu.”

Secondly, accelerate the development of reference laboratories for therapeutic drug monitoring, standardize laboratory construction, and establish external quality assessment programs and guidelines.“A number of drug concentration monitoring laboratories with initial scale and diverse formats have been established in China, but the lack of corresponding standards and guidelines has limited the depth and breadth of drug concentration monitoring. Therefore, Diagreat has collaborated with the Therapeutic Drug Monitoring Research Professional Committee of the Chinese Pharmacological Society, hoping to contribute to the standardization of drug concentration monitoring by sponsoring academic conferences and providing product and technical solutions.”

Finally, promote the application of artificial intelligence in personalized medication guidance.In the past, medication decisions relied heavily on interpretations by clinical pharmacists, with both the number of pharmacists and their professional expertise influencing these decisions. “Diagreat is highly optimistic about artificial intelligence technology and aims to leverage AI to calculate optimal drug concentrations based on patients’ gender, age, weight, ethnicity, underlying conditions, genetic background, and other factors. Currently, the company has conducted preliminary trials in collaboration with several internet companies and hospitals.”

Notably, in addition to therapeutic drug monitoring, Diagreat has also established a strong presence in niche sectors such as reagent raw materials, clinical biochemistry, and point-of-care testing (POCT).

Dr. Zhou Jianping, founder of Diagreat, was formerly a researcher at the Academy of Military Medical Sciences. He undertook numerous military and national research projects, accumulating extensive experience and achievements in the development of in vitro diagnostic (IVD) products. As part of a National 863 Program project focused on developing IVD reagents for chronic cardiovascular and cerebrovascular injuries and emergency indicators, Dr. Zhou successfully developed several key diagnostic reagents for cardiac biomarkers. Unexpectedly, this project directly led to the establishment of a publicly listed IVD company, profoundly inspiring Dr. Zhou Jianping.

“Applying my research findings to clinical practice has always been my dream. This project allowed me, as a researcher at the time, to see for the first time the potential pathways and methods for translating my research into clinical applications,” said Dr. Zhou Jianping.

Driven by interests in applied research and technological industrialization, Dr. Zhou Jianping founded Deaoping Biotechnology in 2012, focusing on the research and development of reagent raw materials, and developed a fullThe world's first detection reagent for neutrophil gelatinase-associated lipocalin.

Subsequently, in 2013, Dr. Zhou Jianping founded Diagreat, leveraging self-developed reagent raw materials to conduct the research and development, registration, and promotion of in vitro diagnostic reagents.

The development of reagent raw materials is highly challenging, characterized by high barriers and long R&D cycles; therefore, most in vitro diagnostic (IVD) companies rely on externally sourced materials. In-house development of reagent raw materials is a key strength of Diagreat. Dr. Zhang Wang stated, “Raw materials are the source of innovation for in vitro diagnostic reagents.”By independently developing and producing raw materials, Diagreat has avoided the risk of supply disruptions from European and American sources, reduced costs, and gained better control over reagent quality.”

Diagreat has achieved full self-sufficiency in the supply of raw materials for its reagent products. In addition to meeting its own reagent development needs, Diagreat also supplies raw materials to other companies, generating substantial gross margins. Revenue from raw material sales currently accounts for approximately 15% of the company’s total revenue, a proportion expected to continue rising in the future.

On the reagent kit front, Diagreat has established product lines covering clinical chemistry, POCT, chemiluminescence immunoassay, and therapeutic drug monitoring.The entire product system is structured as a pyramid, with foundational products at the base., including biochemistry, routine POCT, and chemiluminescence;Mainstream Products in the Middle, including high-value products in biochemistry, POCT, and chemiluminescence, which feature high gross margins and substantial clinical usage, serving as the primary source of profit for Diagreat at this stage;Top tier: exclusive and innovative products, such as therapeutic drug monitoring products, which face limited competition and serve as a testament to the company’s technological prowess.

Leveraging its advantages in self-developed raw materials and a pyramid-shaped product portfolio, Diagreat has successfully secured a position in the in vitro diagnostics industry. To date, DiagreatOver 100 reagent registration certificates have been obtained, with products covering hundreds of hospitals across more than 20 provinces and municipalities in China.Overseas, Diagreat seized the huge demand for COVID-19 testing.The products have been successfully sold to more than 60 countries overseas, with foreign trade sales accounting for 50% of the company's total sales.

Regarding future plans, Zhang Wang stated, “In an increasingly competitive environment, Diagreat will always orient its product development toward clinical needs. Moving forward, the company will accelerate the completion of its pyramid-shaped product portfolio, establishing itself as ‘an emerging-scale R&D and manufacturing supplier of in vitro diagnostics (IVD) led by innovative products,’ to comprehensively meet hospital testing demands. In the longer term, Diagreat will strive to achieve the goal of ‘systematic, comprehensive, and full-coverage IVD offerings,’ positioning itself as a leading enterprise in the IVD industry.”