TagoBio's Digital PCR-Based Non-Invasive Prenatal Testing Kit Validated in Clinical Trials, Poised for Market Entry
Upon his first encounter with digital PCR technology, Dr. Yang Yanfeng was firmly convincedDigital PCR is one of the ideal technologies applicable to non-invasive prenatal screening., which was also his original intention in founding Tago Biologics in 2016.
Dr. Yanfeng Yang has 30 years of experience in the field of molecular diagnostics. He has held leadership roles in the development and commercialization of in vitro diagnostic (IVD) products at leading healthcare companies, including Abbott, Roche, Novartis, Sequenom, and Mindray. Dr. Yang possesses extensive expertise and insight into the research and development of molecular diagnostic technologies, their clinical applications, and emerging trends.
In 1990, Dr. Yang Yanfeng earned his Ph.D. in Biochemistry from Michigan State University and joined Abbott two years later. At that time, molecular diagnostics was in its early stages of clinical application. As one of the pioneers in molecular diagnostics, Abbott successfully launched two PCR-based tests for infectious diseases, marking the beginning of Dr. Yang’s decades-long engagement with PCR technology.
In 2006, Yang Yanfeng joined Sequenom as Senior Director of Research and Development. Sequenom initially attempted to use mass spectrometry-based nucleic acid analysis for non-invasive prenatal screening (NIPS) before shifting its focus to sequencing, becoming the first company globally to commercialize a sequencing-based NIPS product. During this period, Yang Yanfeng was exposed to digital PCR technology and became firmly convinced of its promising prospects for application in non-invasive prenatal screening.
Next-generation sequencing (NGS) offers high accuracy for non-invasive prenatal screening, but its cumbersome procedures, long turnaround time, and high costs—often requiring out-of-pocket payment in most cities—significantly hinder its clinical adoption. Although serological screening is low-cost, it has a low positive detection rate (50%–80%). Currently, the contingent strategy of “initial serological screening, followed by NGS re-screening, and confirmed diagnosis via amniocentesis” is widely used in clinical practice for prenatal screening.
Based on the digital PCR technology platform, Tagene Biosciences has successfully developed a non-invasive prenatal screening kit for fetal chromosomal aneuploidies (T21, T18, and T13) using digital PCR (dPCR-NIPT), and has completed clinical validation with hundreds of samples.
The positive detection rate of digital PCR-based NIPT is similar to that of NGS, with costs approaching those of serological testing., can be included in the aforementioned emergency strategiesReplace serology as a primary screening method with higher sensitivity and specificity, to effectively increase the positive detection rate, reduce the number of false-positive samples requiring rescreening, and save overall screening costs.
With its advantages of absolute quantification, high detection sensitivity, the ability to detect low-abundance targets against a high-abundance background, and strong resistance to interference, digital PCR technology is regarded as one of the most critical technological platforms for the future of molecular diagnostics and is poised to occupy a prominent position in the field of PCR testing. Over the past decade, the digital PCR market has experienced rapid growth at an annual rate of 20%. In recent years, the digital PCR market has become increasingly dynamic: internationally, established players such as Bio-Rad and Thermo Fisher Scientific have continued to increase their investments, while new entrants such as Qiagen and Roche have actively established their presence.
Digital PCR holds broad application prospects and can be utilized in areas such as pathogenic microorganism detection, tumor gene testing, non-invasive prenatal screening, and validation of sequencing results. However, at present, most digital PCR instruments purchased by hospitals are used for research purposes; clinical applications remain in their infancy and have not yet been widely adopted.
Non-invasive prenatal screening is poised to become the killer application for the rapid clinical adoption of digital PCR.First, the demand for innovative technologies in the field of non-invasive prenatal screening (NIPS) that balance cost, accuracy, and speed remains unmet. Second, the NIPS market offers substantial growth potential; although the annual growth rate of newborns in China is slowing, the country still sees over 10 million births each year, presenting significant opportunities.
However, the development of digital PCR-based non-invasive prenatal screening (NIPS) kits is extremely challenging, requiring substantial technical accumulation and experience from the team, making it a largely unexplored field globally. Tago Bio has entered the market through NIPS, dedicating over three years to developing a digital PCR kit for non-invasive prenatal screening of fetal chromosomal aneuploidies. The product has completed clinical validation with hundreds of samples.
In June 2022, the Center for Genetics and Prenatal Diagnosis of the First Affiliated Hospital of Zhengzhou University and Tago Biotech jointly published an article in the Journal of Translational Medicine (impact factor: 5.531), validating the feasibility of digital PCR as a prenatal screening method for T21, T18, and T13. This isThe World’s First Digital PCR-Based Non-Invasive Prenatal Screening Kit Capable of Simultaneously Detecting T21, T18, and T13 from Maternal Plasma Samples in a Single-Tube Reaction Under Blind Testing in Real-World Clinical Settings
The article shows that the overall screening performance of Tago Biosciences' digital PCR kit for non-invasive prenatal screening of fetal chromosomal aneuploidySensitivity was 100%, and specificity was 95.12%., all of which were significantly superior to serological screening.
In addition to its high accuracy, Tago Biotech’s products offer advantages such as low cost, ease of use, and rapid detection, which can accelerate the widespread adoption of non-invasive prenatal screening in hospitals at all levels, particularly in grassroots areas, thereby supporting China’s efforts in birth defect prevention and control.
Tago Bio has establishedModular Reagent Development System, enabling the rapid development of various diagnostic applications. In addition to non-invasive prenatal screening, the company is also strategically positioning itself based on digital PCR technology,Pathogenic Microorganisms, Liquid Biopsy, Cancer Screening...and other application scenarios. However, applications such as cancer genetic testing and liquid biopsy have a relatively small target audience, and the cost of obtaining regulatory approval for these products is high. Companies face an imbalance between investment and return, which limits their enthusiasm for market expansion.
Dr. Yang Yanfeng stated, “Cost is one of the primary factors determining whether a product can be widely adopted in clinical practice.”The explosive growth of emerging technologies such as digital PCR in clinical applications hinges on the opening up of the LDT market.”
The U.S. molecular diagnostics market is highly prosperous, largely due to the standardization and maturity of the Laboratory Developed Tests (LDT) model. In China, the variety of molecular diagnostic tests that have obtained registration certificates is limited, with many being duplicate approvals for the same test, which restricts market development. Currently, China’s LDT policies lack clarity and transparency, exhibit inconsistent levels of openness, and suffer from non-standardized applications. Furthermore, participants demonstrate varying degrees of self-regulation and technical capability. It is imperative for China to promptly establish LDT regulations and standards. Local governments should clearly support and encourage the clinical application of new technologies through LDTs.
“It is foreseeable that the LDT model in China will become increasingly prevalent and standardized in the future.“On June 1, 2021, the latest version of the Regulations on the Supervision and Administration of Medical Devices, issued by the State Council, officially came into effect. Article 53 of these Regulations stipulates that for in vitro diagnostic (IVD) reagents with no domestically marketed equivalents, eligible medical institutions may develop them in-house to meet their clinical needs and use them within their own facilities under the guidance of licensed physicians. The promulgation of these Regulations marks a significant step forward in the standardization of the Laboratory Developed Tests (LDT) model, facilitating the smoother implementation and application of cutting-edge technologies such as digital PCR.”
“As LDT models become increasingly standardized, clinical testing in China will grow more diverse and personalized under their support, making it even feasible to develop customized testing products for small patient populations.”
Dr. Yang Yanfeng believes that molecular diagnostics is a sunrise sector worthy of long-term cultivation. “From a technological perspective, PCR-based nucleic acid testing platforms will remain the mainstay of molecular diagnostics for a considerable period. PCR technology will continue to be improved in terms of simplifying testing processes, shortening turnaround times, increasing multiplexing capabilities, and enhancing throughput. From a business model perspective, many applications are difficult to implement by relying solely on the IVD model; it is necessary to combine the IVD and LDT models to reduce development costs and shorten R&D timelines.”
Tago Biotech's goal isDevelop innovative diagnostic products that are truly applicable in clinical practice.In the digital PCR arena, Tago Bio will accelerate the regulatory submission for its non-invasive prenatal screening (NIPS) test for fetal chromosomal aneuploidy, while actively expediting the application of digital PCR technology in scenarios such as NIPS. Furthermore, the company is not limited to digital PCR but focuses on all detection platforms based on PCR amplification, includingDigital PCR, Fluorescent PCR, Nucleic Acid Mass Spectrometry, Multiplex Detection Chipetc., formingMulti-Technology Platform Layout。