Roche Diagnostics Receives NMPA Approval for Expanded cobas® 4800 HPV Test Indications in China
Roche Diagnostics recently announced that its cobas® 4800 HPV Test (PCR Fluorescence Method) has received approval from China’s National Medical Products Administration (NMPA) for expanded indications covering both primary cervical cancer screening and co-testing applications.
The newly approved intended uses include:
l Primary cervical cancer screening: For women aged 30 years and older, detection of high-risk human papillomavirus (HPV) infection to support cervical cancer screening and patient management.
l Cervical cancer co-testing: For women aged 30 years and older, detection of high-risk HPV infection in combination with cervical cytology testing to support cervical cancer screening and patient management.
As the first imported HPV test approved in China for primary cervical cancer screening, the cobas® 4800 HPV Test significantly expands its clinical application beyond its original indication for triaging ASC-US (Atypical Squamous Cells of Undetermined Significance) patients. The approval broadens its role from targeted risk-based patient management to population-level screening strategies centered on HPV testing, enabling comprehensive coverage across both primary screening and HPV-cytology co-testing pathways.
South African Deputy President Visits Mindray Headquarters in Shenzhen
On June 25, South African Deputy President H.E. Paul Mashatile led a delegation on an official visit to Mindray’s headquarters in Shenzhen, China. The delegation included Mr. Zuko Godlimpi, Deputy Minister of Trade, Industry and Competition of South Africa, and Ms. Dipuo Letsatsi Duba, South Africa’s Ambassador to China. The delegation was received by Mr. Wu Hao, President of Mindray, and Mr. Xu Kewen, General Manager of Mindray’s International Business Division.
During the visit, both sides engaged in in-depth discussions on medical artificial intelligence, digital transformation, talent development, and localization strategies. Mindray has maintained a presence in South Africa for over two decades and established its South African subsidiary in Johannesburg in 2014. Today, the company serves both public and private healthcare sectors across the country, providing medical devices, digital healthcare solutions, and long-term service support. Mindray has developed strong partnerships with leading public hospitals, including Chris Hani Baragwanath Hospital, as well as major private healthcare groups such as Life Healthcare, Mediclinic, and Netcare, contributing to the continuous improvement of healthcare services throughout South Africa.
Kindstar Global and Chongqing Center for Brain and Intelligence Sciences Establish Joint Precision Diagnostics Laboratory
Kindstar Global Group recently entered into a strategic partnership with the Chongqing Center for Brain and Intelligence Sciences to jointly establish a Precision Diagnostics Laboratory. The collaboration will focus on molecular oncology diagnostics and prognostic assessment, while exploring the application of artificial intelligence (AI) foundation models in disease diagnosis, aiming to advance early cancer screening and precision medicine.
The partnership represents a deep integration of industrial clinical expertise and cutting-edge scientific research. Since its establishment in 2022, the center has developed nearly 50,000 square meters of specialized research facilities and attracted leading national scientific talent. It has built strong capabilities and unique platform advantages in biomarker discovery, multi-omics technology development, and translational applications. Kindstar Global is one of China’s leading providers of specialized high-end diagnostic testing services. The company has long been committed to advancing specialty diagnostic technologies and service innovation, playing a pioneering role in promoting the standardization and professionalization of precision diagnostics across China.
BGI Partners with Chulalongkorn Hospital to Introduce NIPT Technology to Thailand for the First Time
To unlock the potential of genomics in precision medicine and public health, the Thai government officially launched the Thailand Genomics Initiative in 2022. Under the program, BGI successfully completed the first-phase whole-genome sequencing of 50,000 Thai individuals in 2025 using its proprietary high-throughput sequencing platform, providing critical technological support and foundational data for the development of Thailand’s population-specific genomic reference database.
Under the leadership of Thailand’s Ministry of Public Health, BGI has also collaborated with several leading local institutions to advance gene therapy applications for thalassemia. In May 2026, BGI Genomics signed a memorandum of understanding with Thailand’s Department of Medical Sciences and GenePlus Thailand to further promote the application of genomic technologies in public health. The collaboration will leverage BGI’s COLOTECT™ stool DNA methylation-based non-invasive colorectal cancer screening technology to strengthen disease prevention and screening capabilities.
Orient Gene Secures Canadian Home Self-Test Authorization and Multiple EU IVDR Certifications
Orient Gene recently announced that several of its domestic and international subsidiaries have obtained a series of major regulatory approvals, including Class III medical device registrations from China’s NMPA, Canadian authorization for home self-testing products, and multiple certifications under the European Union’s In Vitro Diagnostic Regulation (IVDR).
In North America, the company’s wholly owned overseas subsidiary, Healgen Scientific, obtained a Canadian medical device license for its COVID-19 and Influenza A/B Rapid Test Kit (Home Self-Test Version), creating new opportunities in the growing home testing market.
Meanwhile, multiple product categories have successfully obtained EU IVDR certification, further strengthening the company’s global multi-disease diagnostic portfolio. Orient Gene continues to expand its presence in the UK and EU markets, where its immunochromatographic products have already achieved meaningful market penetration. The company is also accelerating the commercialization of advanced technologies, including time-resolved fluorescence diagnostics, molecular diagnostics, microfluidic biochemistry platforms, pathology solutions, and quantum-dot flow fluorescence (liquid chip) systems across European markets.
