Wantai BioPharm Launches ISO 15189 Solution for Blood Centers
Wantai BioPharm has launched an integrated ISO 15189 solution for blood collection and supply institutions, combining professional consulting services with quality control products. The solution is designed to support laboratories in establishing standardized quality management systems aligned with ISO 15189:2022 and CNAS-CL02 requirements, helping improve testing quality, operational efficiency and compliance.
The initiative reflects the growing focus on laboratory standardization and quality management in China’s IVD sector. Beyond diagnostic products, IVD companies are increasingly expanding into laboratory services and quality solutions, supporting blood centers in strengthening personnel management, reducing testing risks and enhancing confidence in laboratory results.
Yeasen Biotechnology and MGI Tech Enter Strategic Partnership on Long-Read Sequencing
Yeasen Biotechnology and MGI Tech have signed a strategic cooperation agreement to jointly develop nanopore sequencing platforms and related reagents. Combining Yeasen Biotechnology’s expertise in molecular biology reagent development with MGI Tech’s nanopore sequencing platform and ecosystem, the partnership will focus on long-read sequencing products and solutions for applications such as complex genome analysis, structural variant detection and transcriptome research.
The collaboration highlights the growing importance of coordination between sequencing platforms and upstream reagents in expanding long-read sequencing applications. The two companies will work on reagent development and commercialization, while exploring broader applications through MGI Tech’s CycloneSEQ ecosystem. By combining long-read and short-read sequencing capabilities, the partnership could further expand sequencing solutions for research, clinical and emerging life science applications.
Mirxes’ FITRAPID Receives Singapore HSA Approval, Expanding into the At-Home B2C Testing Market
Singapore-based RNA biotechnology company Mirxes has announced that its FITRAPID™ at-home colorectal cancer risk screening kit has been approved by the Health Sciences Authority (HSA) of Singapore. Previously approved and launched in Thailand, FITRAPID™ is designed for at-home fecal occult blood testing, offering a simpler and more accessible approach to colorectal cancer and polyp screening. The approval marks Mirxes’ further expansion from the professional healthcare market into consumer-facing B2C testing, with retail pharmacies, e-commerce and direct-to-consumer channels providing new routes to market.
FITRAPID™ is also expected to complement Mirxes’ upcoming CADENCE CRC blood-based colorectal cancer screening product, potentially creating a pathway from at-home initial screening to more advanced molecular testing. Together with its existing products across cancer screening and precision diagnostics, the move reflects the broader shift toward decentralized testing and consumer health management in Southeast Asia. From an industry perspective, Mirxes is increasingly building a dual commercial model that combines professional medical diagnostics with accessible consumer testing, while using at-home screening as a potential entry point for broader cancer prevention and early-detection services.
Yingsheng Bio and Sinopharm Group Med-Tech Partner on High-End Mass Spectrometry
Yingsheng Bio and Sinopharm Group Med-Tech have signed a strategic cooperation agreement to promote the development and adoption of domestically developed high-end mass spectrometry solutions. The partnership combines Yingsheng Bio’s mass spectrometry instruments and reagents with S Sinopharm Group Med-Tech’s nationwide distribution and healthcare supply network, with a focus on expanding access to precision diagnostics and precision medication applications.
The cooperation reflects a broader shift in China’s high-end IVD sector from individual technological breakthroughs toward integrated industrial collaboration. As mass spectrometry is increasingly applied in clinical testing, drug monitoring and other precision medicine scenarios, partnerships spanning technology, manufacturing and distribution could help accelerate the commercialization of domestic solutions and improve their accessibility across different levels of healthcare institutions.
China’s First BCI Product for Cognitive Impairment Auxiliary Diagnosis Approved
China has approved its first brain-computer interface (BCI)-related medical device for the auxiliary diagnosis of cognitive impairment. Developed by Tiankai Suishi (Tianjin) Intelligent Technology, the “Shengong-Shenggao” EEG Signal Acquisition and Cognitive Function Assessment System received a Class II medical device registration certificate from the Tianjin Medical Products Administration on August 31, marking its transition from research into clinical application. The system combines EEG acquisition hardware with software for signal processing and cognitive function assessment, supporting the detection and analysis of brain electrical activity associated with information stimuli.
The approval highlights the accelerating transition of BCI technologies from laboratory research to clinical applications in China. The company has also developed a broader “Shengong” product portfolio covering neurological rehabilitation, cognitive assessment and emotional evaluation, including products targeting conditions such as stroke-related impairment and neurodegenerative diseases. As regulatory pathways for innovative medical devices continue to develop, BCI-based technologies are expected to expand further across neurological diagnosis, rehabilitation and brain health management.
