Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use.

Kryptos Biotechnologies said this week that the Research Investment for Global Health Technology (RIGHT) Foundation has awarded it $1.2 million to further develop its molecular diagnostic testing system for use at the point of care.

bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire SpinChip Diagnostics ASA (“SpinChip”), a privately held Norwegian diagnostics company that has developed a game-changing immunoassay diagnostics platform. The small benchtop analyzer is well adapted to near patient testing as it can deliver a result from a whole blood sample within 10 minutes with the same high-sensitivity performance as the laboratory instruments. bioMérieux has held a minority stake in SpinChip since March 2024.

OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has approved a labeling change to the OraQuick® HIV Self-Test that will increase access to HIV testing for adolescents. The change expands the approved age range to include individuals 14 years of age and older for the OraQuick® HIV Self-Test. Previously the test was approved for use in those 17 and older.

QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in-vitro diagnostic technologies designed for point-of-care settings, clinical labs, and transfusion medicine, today announced financial results for the third quarter ended September 29, 2024.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Roche will now embark on the full integration of the company’s innovative multi-assay point of care platform and the related R&D, operational and commercial sites into its global organisation.

The US Food and Drug Administration recently granted Emergency Use Authorization for a combination COVID-19 and influenza point-of-care test developed by Nano-Ditech.

Challenge Works said Wednesday that it has awarded an £8 million prize to Sweden's Sysmex Astrego for its development of a point-of-care urinary tract infection test that delivers antibiotic susceptibility information in 45 minutes.

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

QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in-vitro diagnostic technologies designed for point-of-care settings, clinical labs, and transfusion medicine, today announced financial results for the first quarter ended March 31, 2024.