Dipu Diagnostics Launches China's First Universal MALDI-TOF Nucleic Acid Mass Spectrometry System, Driving Clinical Adoption of Mass Spectrometry
Clinical mass spectrometry testing is hailed as the next trillion-yuan blue-ocean market. Among its applications, time-of-flight mass spectrometry systems have become essential tools in the genetic testing industry, owing to their multiple advantages, including high throughput, high accuracy, short turnaround times, and low costs.
However, due to the long-standing absence of general-purpose time-of-flight mass spectrometry (TOF-MS) detection systems on the market, TOF-MS testing has faced challenges such as limited clinical application and a narrow range of indications. The approval of DP-TOF, the first domestic general-purpose TOF-MS detection system, undoubtedly marks a new chapter for the clinical application of TOF-MS systems.
On March 26, developed by Digena DiagnosticsLaunch Event for China’s First Approved Universal Time-of-Flight Mass Spectrometry Detection System Held in Hangzhou
The first domestically approved universal time-of-flight nucleic acid mass spectrometry detection system was officially launched at the conference,Director Zhou Zhou, Center for Laboratory Diagnostics, Fuwai Hospital, Chinese Academy of Medical Sciences,Professor Zhu Baoli, Institute of Microbiology, Chinese Academy of Sciences,Dr. Li Tong'en, General Manager of Beijing Zhongyuan Weikang Gene Technology Co., Ltd.,Dr. He Ti, General Manager of Shanghai GeneChem Medical Laboratory, et al.Numerous experts and scholars shared on-site the application achievements and latest advancements of nucleic acid mass spectrometry technology across various fields. Nearly 100 guests from government agencies, healthcare institutions, and enterprises attended in person, while nearly 10,000 industry professionals participated online via live streaming.
Time-of-flight mass spectrometry detection systems began to emerge in China around 2016 and are currently in an early stage of development. Only a very limited number of such systems, including DP-TOF, have obtained registration certificates in the country.
DP-TOF is a medium-throughput genetic testing platform based on the principle of Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS), featuring high sensitivity and high precision. The platform seamlessly integratesHigh Sensitivity of PCR Technology, High-Throughput of Chip Technology, High Precision of Mass Spectrometry, and Intelligent Computer Analysis's powerful features,Offers advantages including multi-gene, multi-locus detection; flexibility in sample volume and type; ease of operation; low cost; short turnaround time for reporting; and high accuracy.
Time-of-Flight Mass Spectrometry Detection System DP-TOF
It is worth noting that, with the exception of DP-TOF, the other approved time-of-flight mass spectrometers have narrow indications and are primarily used for genetic testing of hereditary deafness.DP-TOF is the first domestically approved universal time-of-flight mass spectrometry detection system in China. It can be used for the detection of known nucleotides in samples such as blood, body fluids, and tissues, providing a fully automated solution covering multiple clinical application areas.
Currently, Digena Diagnostics is strategically positioning itself across five key application areas: rational drug use, genetic disease testing, oncology, microbiological testing, and functional medicine. The company is actively developing clinical application products, accelerating the registration and market launch of its reagents, and building a high-end genetic testing ecosystem.
Zhang Yu, CEO of Digena Diagnostics, has dedicated over two decades to the fields of clinical genetic testing and diagnostic applications in China and the United States. Having previously held positions at leading companies such as PerkinElmer, ABI, and Thermo Fisher Scientific in the U.S., he has amassed extensive experience in leading and managing international global teams.
In 2018, after returning to China, Zhang Yu targeted the high-end genetic testing industry and founded Digena Diagnostics, embarking on his entrepreneurial journey.
Why Choose to Start a Business in the High-End Genetic Testing Industry? Zhang Yu stated,The Biggest Pain Point in China's High-End Genetic Testing Market Lies in Instrument Manufacturing“Most companies focus on reagent kit development, while very few are engaged in the manufacturing of high-end equipment, particularly time-of-flight mass spectrometry detection systems. The bottleneck issue of relying on imported instruments is widespread.”
Digena Diagnostic leverages domestically produced high-end genetic testing equipment as its entry point, focusing on the R&D, manufacturing, NMPA registration, and clinical application of high-end genetic testing devices such as time-of-flight mass spectrometry systems, as well as innovative diagnostic kits.Enable everyone to access accurate, affordable, rapid, and simple genetic testing services.
Within just a few months of its establishment, Digena Diagnostic completed its infrastructure construction and built a standard GMP-compliant manufacturing facility. In 2019, Digena Diagnostic overcame multiple technical challenges, including primer design, chip quality stability, and amplification, successfully developing the DP-TOF system. The DP-TOF was subsequently selected as a Key High-Tech Product Development Project in Zhejiang Province for 2019. In July 2020, the DP-TOF completed clinical trials, and in December, it received registration approval from the China National Medical Products Administration (NMPA). In March 2021, the DP-TOF launch event was successfully held, ushering in a new era for the clinical application of time-of-flight mass spectrometry.
As Digena Diagnostic’s comprehensive strengths have become increasingly prominent and clinical mass spectrometry has gained growing momentum year by year, the company has attracted strong confidence from numerous investors. In August 2020, Digena Diagnostic completed its Series A financing round, led by CITIC Securities.
Driven by factors such as consumption upgrading, technological advancements, and policy support, China’s molecular diagnostics market is transitioning from the introduction stage to the growth stage, with promising development prospects. Data shows that from 2013 to 2019, the market size of molecular diagnostics in China increased from RMB 2.5 billion to approximately RMB 13.2 billion, with an average annual growth rate about twice the global average.
The COVID-19 outbreak in 2020 further ignited China’s molecular diagnostics market. During the pandemic, genetic testing played a crucial role in understanding and controlling SARS-CoV-2, allowing the public to fully appreciate the value of genetic testing.As an accurate, rapid, cost-effective, and user-friendly medium-throughput genetic testing platform, the time-of-flight mass spectrometry detection system is poised to enter a golden period of development, driven by the booming molecular diagnostics market.
“Currently, dozens of third-party medical laboratories, including BGI Genomics, Dian Diagnostics, KingMed Diagnostics, and GeneChem, are offering matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) testing services. However, frankly speaking, the clinical adoption of MALDI-TOF MS systems remains limited. Their current stage of development is similar to that of next-generation sequencing (NGS) instruments in their early days around 2012. It took nearly a decade for NGS technology to mature, and I believeTime-of-flight mass spectrometry detection systems will mature more rapidly,It is expected to enter a period of rapid growth in 2023.“, achieving relatively widespread clinical application,” stated Zhang Yu.
Furthermore, to further consolidate Digena Diagnostic’s competitiveness in the high-end genetic testing sector, in addition to developing time-of-flight mass spectrometry detection systems, Digena Diagnostic has also established a presence in the single-molecule nanopore sequencing platform.
Zhang Yu believes that single-molecule nanopore sequencing is a key technology in the genetic testing industry and holds a pivotal position within the sector. “We have observed that clinical attention to and demand for single-molecule nanopore sequencing platforms have gradually increased in recent years, making now the optimal time to establish a strategic presence.”
Next,Digena Diagnostics will leverage its time-of-flight mass spectrometry detection platform and single-molecule nanopore sequencing platform,form complementary advantages,Creating a Leading Manufacturer of Intelligent Gene Analysis Tools, to promote the sound development of China's high-end genetic testing industry.