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.

Point-of-care diagnostic firm Cue Health is laying off all of its employees and shuttering its operations.

T2 Biosystems announced Wednesday that it has regained compliance with a listing requirement to remain on the Nasdaq.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue.

In the First Catalogue of Rare Diseases, which was jointly developed by the National Health Commission of the PRC and five other departments in 2018, there is a rare disease called IgG4-Related Disease (IgG4-RD).

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.

With the application of the latex-enhanced immunoturbidimetry and the enzyme immunoassay amplification, the sensitivity of biochemical test items is greatly improved. Representative products applied in the biochemical technology platform in 2019-2020 are as follows:

The American Society of Clinical Oncology on Friday released guidelines to help guide use of multigene germline genetic testing panels for cancer patients.

Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

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