BigFish Bio-Tech Files IPO Prospectus, Pioneering China's Molecular POCT Market with Innovative Point-of-Care Gene Testing Solutions

BigBioFly recently secured nearly RMB 10 million in angel-round funding earlier this year, with Eagle Fund as the investor. BigBioFly specializes in the research and development of instruments (both hardware and software) and reagents for point-of-care testing (POCT) and mid-to-high-end genetic testing technologies, such as digital PCR. Centered on its cost-effective molecular diagnostic instruments and reagent products leveraging proprietary patented technologies, the company offers a comprehensive automated, intelligent, and industrialized solution. This solution is complemented by the industry’s first IoT modules, an intelligent instrument-reagent data management platform, and fully automated liquid-handling robotic arms.

Currently, Bige Feixu’s product portfolio primarily consists of two major categories: instruments and reagents. In terms of instruments, Bige Feixu offers key products such as gene amplifiers, nucleic acid extractors, and handheld genetic testers (POCT). Gene amplifiers and nucleic acid extractors are relatively mature products in the market. Bige Feixu leverages its core technologies to endow these mature products with unique competitive advantages. Meanwhile, the handheld genetic tester (POCT) is Bige Feixu’s flagship product, filling a gap in the domestic market.

In the IVD market, molecular diagnostics and POCT both hold significant market value. Molecular diagnostics feature high technical barriers and are developing rapidly. Meanwhile, POCT has consistently been in high demand due to its point-of-care testing capabilities. The convergence of molecular diagnostics with POCT means that genetic testing can also offer point-of-care advantages. While this places higher demands on corporate technological capabilities, it also brings substantial market value.

BigFisher’s handheld point-of-care testing (POCT) genetic analyzer is only the size of a water cup, yet it integrates sample preparation, gene amplification, and genetic detection into a single device. It eliminates the risk of cross-contamination by consolidating the functions of traditional professional genetic testing laboratories and large-scale instruments. Paired with rapid-test reagents, it can complete genetic testing within 30 minutes. The product was expected to launch in the first half of 2019.

Company CEO Xie Lianyi stated, “The performance of BigeSeq is consistent with that of large-scale instruments, while the cost of both the instrument and single tests is significantly lower than Cepheid’s, estimated at one-tenth of Cepheid’s price. This represents a major advantage for the company.”

In addition to medical applications, Bige Sequencing’s molecular POCT products can also be deployed in public security, animal husbandry, food safety, and other sectors. Equipped with built-in batteries, these devices enable rapid genetic testing without external power sources, thereby broadening their applicability across diverse scenarios. Currently, the company’s handheld gene analyzer has established substantial cooperation intentions with several state-owned enterprises and central state-owned enterprises in areas such as animal husbandry, elderly care, and health checkups.

For mature instrument products such as thermal cyclers and nucleic acid extraction systems, Bige Sequencing utilizes self-produced raw materials and proprietary core technologies, reducing instrument and reagent costs by 30% and offering a price advantage over competitors.

Taking the domestic PCR market as an example, PCR technology is widely used and is currently evolving from qualitative to quantitative applications. Although domestically produced products have been adopted in the mid- and downstream sectors, upstream raw materials such as polymerases and primer fragments still rely heavily on imports. To break the deadlock of foreign giants’ monopoly on the market and gain greater bargaining power, Chinese enterprises need to master more core technologies.

In addition to its price advantage, Bige Feixu also boasts performance advantages (such as ultra-micro extraction technology). Its core instrument specifications and supporting reagent performance are on par with similar products from well-known foreign companies, further raising the technical barrier for domestically produced products and enabling them to compete in the international market.

In addition to its molecular POCT product portfolio, Bige Feixu has also expanded into the fields of high-end digital PCR instruments and nanopore sequencing. Currently, these two product lines are in the technology reserve stage. Bige Feixu is engaging with consumables suppliers and has already developed a relatively mature design for experimental sample processing.

Digital PCR can directly quantify the number of DNA molecules, representing the most advanced technology in PCR detection. Nanopore sequencing, which represents the third generation of gene sequencing technologies, offers higher throughput, lower costs, and more compact, portable instruments. Once the technology matures, it has the potential to disrupt Illumina’s current dominance in the upstream gene sequencing market.

BigFisseq has also built an instrument-and-reagent-based Internet of Things (IoT) platform by embedding NB-IoT modules into its laboratory instruments, enabling users to upload test data in real time and thereby providing intelligent data analytics services.

Furthermore, the various sensors built into the instrument can upload its status in real time, accelerating after-sales response. The platform also monitors customers’ daily experimental activities, enabling fully automated settlement of reagent and consumable usage, thereby making companion reagent sales more intelligent.

Xie Lianyi, Founder and CEO of Bige Feixu, graduated from Zhejiang University with a degree in Information Engineering. He has held senior executive positions at Fortune 500 companies and renowned genetic testing firms, accumulating nearly two decades of R&D experience in the IT and life sciences sectors.

Following the completion of its angel round earlier this year, Bigfishseq is currently raising a Pre-A round. The proceeds from this financing will be directed toward R&D investments in core product areas, including molecular point-of-care testing (POCT) and digital PCR.