Different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.

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

As of the end of August 2021, the first-half reports of IVD-related listed companies have basically been released. 64 IVD-related listed companies have achieved steady growth in the first half of 2021, and more than 70% of companies have shown positive growth in net profits.

Companies that have already registered their devices in the EU will still be able to sell their products in Great Britain until June 2023. From this point, they will be required to register their device for UK Conformity Assessed (UKCA) marking.

The second quarter revenues of Burning Rock Biotech were up 19 percent year over year. The Chinese precision oncology firm recorded total revenues of RMB 127.3 million ($19.7 million) for the three months ended June 30, 2021, up from RMB 107 million for the same period in 2020.

The US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver to a multiplex assay from Visby Medical to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The assay uses an instrument-free, single-use PCR device.

On August 17th, Autobio released a semi-annual performance report stating that the operating income was 1.678 billion yuan, an increase of 39.13% year-on-year; the net profit attributable to shareholders of listed companies was 413 million yuan, an increase of 50.63% year-on-year.

A federal jury on Friday ruled that Qiagen willfully infringed two patents owned by ArcherDx (now part of Invitae) and Massachusetts General Hospital and ruled that Qiagen must pay royalties and lost profits totaling about $4.7 million.

The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).

LumiraDx reduced the terms of the valuation for its SPAC merger from $5 billion to$3 billion citing a decline in COVID-19 testing

The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Mount Sinai Hospital and Empire City Laboratories.

Genetron Health collaborates with Yikon Genomics, expanding S5 Platform's reach to reproductive health field; AmoyDx collaborates with Amgen to develop companion diagnostics for Japan market; AcornDx collaborates with BGI to develop accurate diagnosis on urinary system tumors