Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Not every assay needs the same substrate. But every assay needs the right one.

Roche announced on Monday that its Cobas Pure Integrated Solutions instrument has received 510(k) clearance from the US Food and Drug Administration.

Cancer detection startup Naveris said Monday it has secured a $33.4 million expansion of its Series A financing round to reach a total investment in the firm of $51 million that will be used to commercialize and advance its early, viral-driven cancer detection tests.

The domestic in vitro diagnostic (IVD) leader in the post-epidemic era is targeting India, which is growing as fast as the Chinese market. Fapon Biotech has been deployed in the Indian market for nearly 15 years, and the in vitro testing raw materials have more than half of the local market share.

BriaCell Therapeutics said that it has signed an agreement with Caris Life Sciences to support patient identification and enrollment of genetically defined subgroups for a current Phase I/II clinical trial in advanced metastatic breast cancer.

Qiagen announced on Thursday that it has obtained the CE-IVD mark for RT-PCR assays to detect and quantify Epstein-Barr virus and human herpesvirus-6 on its NeuMoDx instruments.

At the beginning of this year, Roche Diagnostics China and Changchun Sunostik Medical Technology Co., Ltd. entered into a strategic partnership and jointly launched a new RS600 laboratory automated system for the Chinese market.

NIMA Partners and EmpowerDx said Thursday they will jointly promote EmpowerDx's genetic test that helps determine a patient's risk for developing celiac disease.

Belgian molecular laboratory software vendor UgenTec said Thursday that it has entered into a deal with Thermo Fisher Scientific to jointly commercialize several new CE-marked respiratory assay plug-ins for its FastFinder analysis software.

On September 14, Shanghai Upper Bio-Tech Pharma Co., Ltd. was listed on the National Equities Exchange and Quotations (NEEQ) in China market. The transaction method is call auction, and the level to which it belongs is the basic layer.

DiaSorin said Wednesday it had gained US Food and Drug Administration 510(k) clearance for a swab-based COVID-19 PCR assay that delivers results in about one hour.