QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).

The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.

The $3.95 billion worldwide molecular diagnostic POC testing market is seeing increasing international activity with China becoming a particularly intriguing part of the Asia Pacific region according to The Market and Future Potential for Molecular Point of Care, published by Kalorama Information.

QuidelOrtho said on Monday that it has received Canadian approval for a rapid point-of-care assay for myocardial infarction diagnosis.

Canadian firm Genomadix has entered into a collaboration with the Mayo Clinic to advance its point-of-care molecular analyzer technology.

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.

Point-of-care diagnostics firm LumiraDx and special purpose acquisition company CA Healthcare Acquisition said on Monday that they have revised the terms of their previously announced merger to lower the equity value of the combined company.

Researchers have demonstrated a prototype of a rapid COVID-19 molecular test and a simple-to-use, portable instrument for reading the results with a smartphone in 30 minutes, which could enable point-of-care diagnosis without needing to send