Diagnostic test maker Technoclone on Tuesday said it has secured US Food and Drug Administration de novo marketing authorization for a test that is used to aid the diagnosis of a rare, life-threatening blood-clotting disorder.

Invitae (OTC: NVTA), a leading medical genetics company, today announced estimated unaudited fourth quarter and full year 2023 revenue, gross profit and cash burn.

Fujirebio Europe has acquired the nonexclusive distribution rights to Self-screen's PreCursor-M AnoGyn assay in Europe, the Middle East, Africa, and Asia, the companies said on Tuesday.

Danaher subsidiary Beckman Coulter Life Sciences announced Tuesday that its DxFlex Clinical Flow Cytometer has received 510(k) clearance from the US Food and Drug Administration.

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DiaSorin has received the US Food and Drug Administration’s 510(k) clearance for its LIAISON PLEX platform and the accompanying LIAISON PLEX Respiratory flex assay.

The US Food and Drug Administration last week granted Emergency Use Authorizations for two point-of-care COVID-19 and influenza combination tests developed by Sekisui Diagnostics.

Thermo Fisher Scientific, the world leader in serving science, will significantly expand local operations in Indonesia with the opening of its first official office. The inauguration of the new facility in Jakarta is scheduled for April, signifying a key milestone as the company transitions from its current representative office to a larger workspace.

Ginkgo Bioworks (NYSE: DNA), a Boston, MA-based company which is building a platform for cell programming and biosecurity, announced the acquisition of Proof Diagnostics, a life sciences tools, diagnostics and computational discovery company.

French diagnostics firm Sebia said Thursday that it has received US Food and Drug Administration 510(k) clearance for its FLC Kappa and Lambda assays.

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the fourth quarter and year ended Dec. 31, 2023.

CareDx, Inc. (Nasdaq: CDNA) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported its financial results for the fourth quarter and year ended December 31, 2023.

In 2023, a total of 12,213 first registrations, renewals of registrations and changes of registrations of medical devices were approved by NMPA, representing an increase of 2.3% in the total number of registration approvals compared with 2022.

OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, sample management solutions, and microbiome laboratory and analytical services, today announced its financial results for the three months ended December 31, 2023.