The Jiangsu Provincial Department of Industry and Information Technology recently published its proposed 2026 list of technologies and products under the ‘Three Firsts, Two New’ programme. Xuzhou High-Tech Zone recorded one first-of-its-kind equipment system, one first-batch new material and 13 new technologies or products on the list. The programme is a core evaluation system for fostering innovation in Jiangsu: the ‘Three Firsts’ refer to first-of-its-kind equipment, first-batch new materials and first-release software, while the ‘Two New’ categories are new technologies and new products. To showcase local companies' scientific and technological capabilities, Xuzhou High-Tech Zone's publication is presenting a series of features on selected enterprises and their materials, technologies and products.

Mycobacterium tuberculosis and Rifampicin Resistance Gene Detection Kit (Fluorescence PCR Method)

The Mycobacterium tuberculosis and Rifampicin Resistance Gene Detection Kit (Fluorescence PCR Method) is an innovative molecular diagnostic product for tuberculosis prevention and control. Built on Rocgene (Xuzhou)'s independently developed iFIND fully automated testing and analysis platform, it combines amplification with probe melting curve analysis to detect Mycobacterium tuberculosis and rifampicin resistance-associated genes simultaneously. The assay covers the full 81-bp target region of the rpoB gene and uses multiple verification targets in IS1081 and IS6110. Its detection limit is 10 bacteria/mL, with a resistance detection limit of 100 bacteria/mL. Its performance reaches an advanced international level, and it is described as the only domestically developed tuberculosis testing product capable of providing an equivalent alternative to WHO-recommended methodology. Freeze-dried reagents can be stored and transported at room temperature without a cold chain. An integrated microfluidic cartridge enables fully enclosed, automated processing: after sample loading, the instrument completes nucleic acid extraction, amplification, detection and result interpretation without opening the cartridge or requiring manual intervention. The design addresses challenges in conventional tuberculosis testing, including difficult cell-wall disruption, complex operation, contamination risk and limited suitability for primary healthcare facilities.

Applications

The product supports a broad range of applications across the tuberculosis prevention and control pathway, including centres for disease control and prevention, tuberculosis control institutions, designated hospitals and primary healthcare facilities. Uses include initial diagnosis of suspected cases, identification of sputum smear-negative cases, rapid rifampicin resistance screening, testing of extrapulmonary tuberculosis samples and screening of high-risk populations. Beyond tuberculosis, the platform can be expanded to testing for viruses such as HIV, HPV and influenza, and bacteria such as Clostridioides difficile and MRSA. It supports diagnosis of infectious diseases, clinical drug selection and hospital infection control, contributing to the tuberculosis control goals of Healthy China 2030 and the public-health emergency response system.

Innovations

1. Built-in ultrasonic extraction: Integrates cell-wall disruption and nucleic acid extraction to process organisms with thick cell walls efficiently, while avoiding open-lid contamination associated with separate external equipment.

2. Nested amplification: Efficient, staged amplification with two primer sets improves sensitivity and specificity and reduces missed detection in samples with low bacterial loads.

3. Fully enclosed intelligent microfluidic cartridge: A one-piece injection-moulded design reduces leakage risk. Seven testing processes are automated, enabling a sample-in, result-out workflow with a single sample-loading step.

4. Modular, on-demand testing: Multiple modules operate in parallel and accept samples as they arrive, improving equipment utilisation and testing efficiency. Highly specific primers and probes, high-fidelity enzymes and an innovative freeze-drying protectant formulation support precise amplification and long-term room-temperature stability, balancing performance, cost and convenience.

Results in Practice

In clinical use, the product provides rapid diagnostic results to support timely care. Its fully enclosed workflow, with no cartridge opening, helps prevent aerosol contamination and meets high biosafety requirements. The equipment does not require a dedicated PCR laboratory and can be operated by personnel after training, helping address gaps in tuberculosis testing capacity at primary healthcare facilities. Performance is benchmarked against imported products, with a price equivalent to 70% of comparable imports, reducing procurement and operating costs for disease control and medical institutions. Across the industrial value chain, the instrument, reagents and core technologies are independently developed and produced in China. The product strengthens tuberculosis prevention and control capabilities, supports WHO's goal of ending the tuberculosis epidemic by 2035, and provides a practical example of domestic development of advanced molecular diagnostic medical devices while supporting innovation in the high-tech zone's biopharmaceutical industry.

Company Profile

Rocgene (Xuzhou) Scientific Instruments Co., Ltd. established operations in Huaihai Pharmaceutical Industrial Park in Xuzhou High-Tech Zone in 2019. It is a National High-Tech Enterprise and a Jiangsu specialised and innovative enterprise. The company has more than 10,000 m² of GMP-standard production space, four instrument production lines and three reagent production lines. Certified to ISO 13485 and ISO 9001, it covers research and development, manufacturing, sales and service. Its team of scientists and international business professionals focuses on translating life-science technologies into precise diagnostics for infectious diseases, particularly tuberculosis and respiratory pathogens. The company has obtained eight Class III medical device registration certificates and multiple international certifications and approvals, including CE, FDA and MHRA. It holds 10 invention patents, seven utility model patents and 27 software copyrights, and exports to nearly 20 countries. It combines independently developed core technologies with competitiveness in global molecular diagnostic markets.