Digital PCR, open the golden age!
In the post-epidemic era, where will molecular diagnostic technology go?
Fluorescent quantitative PCR technology with a high market maturity lost its direction with the disappearance of the epidemic, and its products were homogeneous and seriously involved. According to media reports, medical institutions have tens of thousands of sets of fluorescent PCR instruments shelved.
The involution of conventional PCR opens a window for digital PCR.
Digital PCR (Digital PCR, dPCR for short) is the third-generation PCR technology and one of the key technologies in life science and medical diagnosis. The core idea is to dilute template molecules and evenly distribute them to tens of thousands or hundreds of thousands of independent reaction units, perform PCR amplification, and achieve single-molecule absolute quantification independent of standards and standard curves through the presence or absence of PCR end-point signals.
Compared with fluorescent PCR technology (second-generation PCR), dPCR has many advantages, which are mainly reflected in the following aspects: high sensitivity, single-molecule-level detection; accurate quantification, independent of standard substances and standard curves, absolute quantification can be achieved, which is the gold standard for absolute quantification; high stability, good at detecting rare targets under the interference of complex background templates, and good tolerance to inhibitors.
According to the forecast of Gaohe Investment Research Center, from 2020 to 2024, the market size of China's dPCR industry will still maintain a relatively high growth rate, and the market size will increase from 2.133 billion yuan to 7.011 billion yuan, with a compound annual growth rate of 34.65%.
Internationally, companies such as Bio-Rad, Qiagen, Thermo Fisher Scientific, Roche, and Illumina have deployed dPCR business through acquisitions and investments. Domestically, IVD companies such as Xinyi Bio, Ruixun Bio, Pioneer Gene, Little Turtle Technology, Zhenzhun Bio, Covis, Yongnuo Bio, and Sinafor Medical have emerged. Listed IVD companies such as Mike Bio, New Industry, and Ambion have all invested in dPCR companies.
At present, the application of dPCR has covered many fields.
One is the early and rapid diagnosis of infectious diseases. Utilizing the characteristics of high sensitivity and absolute quantification of digital PCR, it can dynamically monitor pathogenic microorganisms and drug-resistant genes, and provide reference for the formulation and adjustment of clinical programs.
The second is tumor gene detection, which provides reliable detection products for early warning, prognosis judgment, curative effect prediction and evaluation of lung cancer, breast cancer, digestive tract tumors, thyroid cancer and other diseases. With its ultra-high sensitivity and absolute quantitative advantages, digital PCR is especially suitable for liquid biopsy of tumors. It can overcome the shortcomings of low tumor-derived nucleic acid content and complex background in such specimens, and has good application prospects in minimal residual disease (MRD), efficacy evaluation, disease progression, and dynamic monitoring of clonal evolution.
The third is birth defect screening, which can carry out faster, cheaper and more accurate screening for chromosomal diseases such as Down syndrome and genetic diseases such as SMA (spinal muscular atrophy). Digital PCR technology can ensure the accuracy of chromosome copy number quantification when the sample size is relatively rare, and meets the technical needs of Down syndrome screening. The detection of SMN2 gene copy number is accurate, fast and economical, which can meet the needs of SMA clinical gene detection and prenatal diagnosis.
The advanced nature and important value of digital PCR technology have become the consensus of the industry. With the continuous growth of the detection market and the continuous improvement of detection requirements, digital PCR is bound to become a key technology platform for clinical molecular diagnosis and usher in rapid growth.
The national public bidding results show that since 2013, the number of digital PCR winning bids has changed from a single-digit era to more than a hundred. Especially in 2021 and 2022, the number of digital PCR winning bids exceeds more than 300 sets each year, and digital PCR is being deployed in major fields such as university research institutes, customs, disease control, and hospitals. In addition to the above-mentioned government bidding departments, the industrial field includes the fields of molecular diagnosis, measurement and valuation, and biopharmaceuticals. Therefore, digital PCR has become a technology recognized and affirmed by the country and the whole industry, and there is huge room for future development.
2023 may become the first year of the outbreak of digital PCR clinical application. Since 2019, many domestic IVD manufacturers are deploying digital PCR clinical detection kits (tumor, pathogen, reproductive health, etc.). After the new coronavirus (2019-nCoV) nucleic acid detection kit independently developed by Beijing Xinyi Biotechnology Co., Ltd. in January 2022 obtained the Class III medical device registration certificate. On June 20, the "MPR1A/PLAC8 gene methylation detection kit (digital PCR method)" of Guangzhou Youze Biotechnology Co., Ltd. was approved by the NMPA of the State Food and Drug Administration. This also means that more and more reagents based on digital PCR methods will obtain registration certificates, behind which are countless IVD manufacturers queuing up for registration based on digital PCR.
The spring of digital PCR has arrived.
