Although it is still autumn, the cold winter has already arrived for the IVD industry. The sporadic growth dividends are no longer present, and the entire industry is caught in fierce competition, prompting companies to seek leaner operations for survival and new development opportunities. This trend is not unique to the IVD industry; even the IT and mobile internet industry, which has led global economic development for many years, is entering a period of contraction.

Currently, the world is more eager than ever for white knights to bring new technological breakthroughs and industrial upgrades. Just as Korean scientists were about to ignite the flame of room temperature superconductivity, the fourth industrial revolution seemed imminent, only to have the flame of hope extinguished. Fortunately, the emergence of OpenAI's large language model has unveiled the true beginning of the AI era, with generative AI and embodied AI poised to take over from the mobile internet, rekindling the spark that will lead the world into a new industrial revolution.

So, in the field of molecular diagnostic IVD, are there similarly disruptive and innovative technologies and products with breakthrough potential?

After the pandemic, numerous hospitals established PCR laboratories, but most fluorescence PCR devices are now gathering dust. The NGS field is also facing challenges, with the leading industry significantly cutting down on tumor LDT business, highlighting the difficult situation of NGS business under the backdrop of healthcare reform and anti-corruption in the medical field. Although tNGS showed some popularity in the infectious disease detection field, it also faced controversies. At this juncture, a new technology/product platform that combines the advantages of fluorescence PCR and NGS while overcoming their disadvantages becomes urgent. This ideal product can be defined as qPCR-PLUS/NGS-SHARP:

As a third-generation PCR technology, digital PCR has garnered attention since its inception and has been applied in areas such as liquid biopsy for tumors, genetic reproductive testing, and environmental microbiology testing. However, due to the insufficient technological innovation and product improvement of digital PCR, it has not truly gained momentum in the IVD field. Moreover, it faces the dilemma of being squeezed between qPCR and NGS, leading many to hold a pessimistic view of the application prospects of digital PCR in the IVD field.

Nevertheless, several companies in the industry continue to innovate and make breakthroughs in the field of digital PCR. Particularly noteworthy is Turtle Technology's recent release of the digital PCR 2.0 solution and the latest SCI Digital digital PCR mini all-in-one machine, which has taken the lead in heralding the transformation of digital PCR towards qPCR-PLUS/NGS-SHARP.

Digital PCR technology has long been a focus in the molecular diagnostic field. Besides Turtle Technology, numerous innovative domestic enterprises such as TargetingOne, Pilot Gene, Forevergen, Sniper Tech, and ZZBio, as well as internationally renowned companies like Illumina, Thermo Fisher, Roche, and Qiagen, are actively positioning themselves in this field. Whether the qPCR-PLUS/NGS-SHARP solution based on digital PCR 2.0 can truly bring about a transformative change in the IVD industry after decades of stagnation remains to be seen. We look forward to witnessing more innovation from both domestic and international IVD manufacturers, fostering collaboration, and anticipating policy-making bodies to provide policy-level support for leading innovation by IVD enterprises, making precision diagnostics more widespread, accessible, and efficient.