Focusing on POCT Innovation,

Domestic Molecular Diagnostics Leading New Trends in Tuberculosis Control

On June 26, 2025, the "iFIND TBR New Product Launch Conference" hosted by Rocgene was successfully held in Shaoxing. The conference invited authoritative experts from the Chinese Antituberculosis Association, Chinese Center for Disease Control and Prevention, many tertiary hospitals, and provincial/municipal CDCs to discuss the latest advances in molecular diagnostic technologies for tuberculosis and witness the launch of Rocgene’s domestically developed Mycobacterium tuberculosis and rifampicin resistance detection kit.

Domestic Innovation Breakthrough, A Promising Future

Mr. Guo Qiuzhen, Founder and Chairman of Rocgene, delivered a welcome speech on behalf of the company and thanked all guests for their presence: "The core of POCT lies in miniaturization and convenience, and Rocgene’s vision is to make molecular diagnostic technology accessible to everyone. As a domestic enterprise with 10 years of deep cultivation in the industry, we have always been clinical‑needs‑driven, committed to technological innovation, and forged ahead through continuous exploration." He especially thanked the expert team for their support to domestic enterprises and emphasized that Rocgene will always uphold the mission of "diagnosis for the people".

Professor Liu Jianjun, Chairman of the Chinese Antituberculosis Association, emphasized: "Ending the tuberculosis epidemic still has a long way to go, but technological innovation has greatly boosted our confidence. Over the past decade, with national policy support and joint industrial efforts, the etiological positivity rate of tuberculosis patients in China has risen from 30% to 71%." Chairman Liu highly recognized the iFIND system and called: "Local enterprises must continue to innovate and break through, and all parties need to unite and collaborate to build a China TB Prevention Consortium and jointly achieve the strategic goal of ending TB through nationwide action."

Director Yu Fangyou from Shanghai Pulmonary Hospital also expressed his expectation for trial evaluation and stressed: "As a newly launched product, iFIND TBR needs long‑term practice to verify its performance stability and accumulate more comprehensive clinical usage data. Market recognition ultimately depends on its actual quality and performance."

Mr. Chen Bin, Vice Chairman of Zhejiang Antituberculosis Association, congratulated the launch of iFIND on behalf of the host city and expressed hope that more molecular diagnostic technologies will play a role in primary diagnosis and screening to help end the tuberculosis epidemic.

Clinical Validation and Performance Advantages Widely Recognized

At the conference, Director Huang Hairong from Beijing Chest Hospital, on behalf of all clinical institutions participating in the iFIND clinical study, announced the clinical data of the TBR and IFQ kits: "iFIND TBR shows high consistency with Xpert and phenotypic drug susceptibility results. Its IFQ kit is the first domestically developed pre‑XDR detection product based on a fully integrated platform using sputum samples, providing an important tool for early screening of drug‑resistant tuberculosis."

Researcher Ou Xichao, Secretary‑General of the Basic Professional Committee of the Chinese Antituberculosis Association, commented from a public health perspective: "The iFIND detection system demonstrates significant performance advantages: its sensitivity reaches 13.4 CFU/mL, nearly 10 times higher than the first‑generation Xpert, and comparable to Xpert Ultra. In previous single‑center validation studies, iFIND TBR showed excellent detection efficiency compared with clinical diagnosis, solid culture, and Xpert results, especially in positive detection rate. In addition, the IFQ kit also showed good consistency with phenotypic drug susceptibility test results." The Chinese Antituberculosis Association will conduct a multicenter clinical application evaluation of iFIND TBR with Rocgene to further verify its clinical value.

Mr. Xu Gang, Marketing Director of Rocgene, reviewed the R&D journey of iFIND with the theme of "Breaking Through and Innovating": "From the optimization of fluorescence system algorithms to the miniaturization of ultrasonic modules, we have gradually broken technical barriers and achieved a leap in domestic fully integrated platforms."

Roundtable Discussion

Clinical Needs Drive Product Progress

The roundtable discussion was moderated by Professor Xia Hui, Deputy Director of the Basic Professional Committee of the Chinese Antituberculosis Association, and invited senior experts in the tuberculosis field to participate.

Director Ren Yi from Wuhan Pulmonary Hospital recalled: "From the early use of Rocgene domestic PCR instruments to participating in the multicenter clinical trial of iFIND TBR, we have witnessed the rapid growth and technological breakthroughs of domestic medical devices."

Director Tan Yunhong from Hunan Chest Hospital pointed out: "During the GCP certification process, the professionalism and pragmatic style demonstrated by the Rocgene team in the face of challenges impressed us deeply. Through close cooperation and joint efforts, both parties successfully completed the certification."

Director Deng Yunfeng from Shandong Public Health Clinical Center stated: "I hope that in the future we will have high‑quality domestic products to choose from, especially looking forward to the implementation of POCT at the primary level. Just as the name 'iFIND' implies, future evaluations may come not only from clinical laboratories but also from real feedback of primary medical institutions and the general public."

Director Shen Adong from Beijing Children’s Hospital specially emphasized: "Pediatric tuberculosis diagnosis faces difficulties in sample collection, and gastric juice testing is an urgent clinical pain point. We expect Rocgene to achieve key breakthroughs in this field."

Professor Tan Yaoju from the State Key Laboratory of Respiratory Diseases proposed: "I hope iFIND TBR can expand its application in the diagnosis of extrapulmonary tuberculosis and asymptomatic tuberculosis. Meanwhile, full‑process quality control from sample collection, processing to detection is crucial. As a local enterprise, if it can provide more cost‑effective solutions, it will surely make a greater contribution to ending tuberculosis."

With the successful conclusion of the launch conference, iFIND TBR officially sets sail. It is expected that this heavyweight new product, with its brand‑new appearance, excellent performance, reliable quality, and high‑quality service, will join hands with experts and customers in tuberculosis prevention, control, diagnosis, and treatment to strive for the strategic goal of ending the tuberculosis epidemic.