IVD China last week: Autobio, Wondfo, Dynamiker

Over 40 IVD Companies Support Chikungunya Virus Diagnosis Amid WHO Alert

On July 22, the World Health Organization (WHO) issued a global alert concerning chikungunya, a mosquito-borne disease, urging countries to prepare and prevent potential large-scale outbreaks. At a press briefing held in Geneva, head of WHO’s Arbovirus Unit stated that chikungunya virus transmission has now been reported in 119 countries and regions, placing approximately 5.5 million people at risk.

Chikungunya is an acute infectious disease caused by the chikungunya virus and is primarily transmitted through bites from Aedesmosquitoes, commonly known as "tiger mosquitoes." The virus is not transmitted directly between humans. Effective prevention hinges on mosquito control, elimination of standing water, and protection against bites. According to a statement issued by the Foshan Municipal Health Commissions, as of July 23, 2025, the city has reported 3,645 confirmed cases of chikungunya.

In line with the Chikungunya Diagnosis and Treatment Protocol (2018), chikungunya virus testing includes nucleic acid detection, virus isolation, and serological assays. More than 40 in vitro diagnostics (IVD) companies have stepped up to support the screening and identification of the virus—among them: Wondfo Biotech, Fosun Diagnostics, Bojie Medical, BGI, Dian Diagnostics, BioPerfectus, Rendu Biotechnology, QIAGEN, Wantai BioPharm, Sansure Biotech, Daan Gene, Easy Diagnosis, and ZJ Bio-Tech, among others.

Autobio Expands Regional Collaboration in Malaysia

From July 17 to 21, Autobio Diagnostics hosted a series of high-level events in Kuala Lumpur, Malaysia. On July 17, Autobio signed a Memorandum of Understanding (MoU) with its strategic partner Interscience Sdn Bhd and Malaysia’s leading diagnostic chain Premier Integrated Lab (PIL), which operates 35 laboratories across the country. PIL holds multiple international accreditations, including CAP, MS ISO 15189, MSQH, and JCI, and is part of IHH Healthcare Berhad, the world’s second-largest healthcare group.

On July 19, in collaboration with its Indian strategic partner Matrix Labs Diagnocare PVT. LTD., Autobio officially launched the AutoLumo S900 chemiluminescent immunoassay system tailored for the Indian market.

On July 21, during the 50th Malaysian Conference of Pathology and Laboratory Medicine organized by the College of Pathologists, Malaysia, Autobio subsidiary Bioyuan signed an MoU with MCPATH QAP SDN. BHD. (McQAS), a prominent provider of external quality assessment (EQA) services in Malaysia, underscoring its influence in IVD quality control within the region.

Wondfo Biotech Launches Human MSI Detection Kit

Wondfo Biotech received Class III medical device registration approval from China’s National Medical Products Administration (NMPA) for its independently developed Human Microsatellite Instability (MSI) Detection Kit (based on fluorescence PCR melting curve analysis). The kit features innovative site design and a breakthrough methodological approach, setting a new paradigm in MSI detection.

Microsatellite instability (MSI) is a genetic phenomenon resulting from DNA replication errors that cause changes in the length of microsatellite sequences. MSI is commonly found in colorectal, endometrial, and gastric cancers. MSI testing holds significant clinical value in solid tumors, playing a critical role in Lynch syndrome screening, 5-FU-based chemotherapy guidance, prognosis stratification, and identifying patients who may benefit from immune checkpoint inhibitors.

Dynamiker Biotechnology's G and GM Fungal Diagnostic Kits Approved by New York State CLEP

On July 21, 2025, Dynamiker Biotechnology announced that its proprietary (1-3)-β-D-Glucan Detection Kit (colorimetric method, "G test") and Galactomannan Detection Kit for Aspergillus (ELISA method, "GM test") have received approval under the New York State Clinical Laboratory Evaluation Program (NYS CLEP). Both kits are now authorized as Laboratory Developed Tests (LDTs) in the state of New York (see attachments for documentation).

This milestone reflects Dynamiker Biotechnology’s technological leadership in the diagnosis of invasive fungal diseases and marks a major step forward in the internationalization of its precision diagnostic products for fungal infections.