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

Canadian diagnostics firm MedMira on Wednesday said it has secured US Food and Drug Administration 510(k) clearance for the HIV-2 claim that will be used in its rapid antigen tests for HIV-1/2 detection.

Liquid biopsy firm SeekIn said Friday that it has entered into a strategic collaboration with Oncolnv, a fully-owned affiliate of Inspire2Live to expand the global accessibility of the firm's menu of cancer detection tests.

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa) and Sysmex Corporation (President: Kaoru Asano) today announced that they have signed an agreement for the mutual supply of reagent raw materials owned by both companies (“the Agreement”). The Agreement is based on a basic agreement on business collaboration in the field of immunoassay*1 which the two companies signed in October 2023.

Abbott’s new laboratory automation system has received U.S. Food and Drug Administration (FDA) approval, the company announced in a statement.

Two recent Parkinson’s announcements suggest a new biomarker test panel coming, as well as cell culture systems for studying Parkinson’s in the laboratory.

Alveo Technologies said Wednesday that it has struck 19 agreements for the distribution of its point-of-care molecular diagnostic products throughout Europe, Africa, and the Middle East.a

On 8 December, Zhejiang Healthcare Security Administration issued a notice on managing and encouraging the breakthrough medical technology.

Tome Biosciences, a new genome editing company, emerged from stealth on Tuesday and announced that it has raised $213 million between its Series A and B financing rounds.

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of the Thermo Scientific™ KingFisher™ Apex™ Dx, an automated nucleic acid purification instrument, and Applied Biosystems™ MagMAX™ Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens. Together these products provide laboratories with an in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions for increased confidence in downstream results.

Various automated immunoassay analyzers were applied in clinical lab using different principles, which offered great convenience to our daily work in the laboratory, with more stability and accuracy than manual operation.

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

PlumCare and Fabric Genomics said Thursday that they have partnered to integrate the Fabric AI platform with PlumCare’s FirstSteps newborn genome screening program in Greece.

Danish diagnostic firm Bioporto announced on Friday that its test for acute kidney injury in hospitalized children has received clearance from the US Food and Drug Administration.

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QScout™ rapid-result hematology system, which provides fast, point-of-care white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number and percent of five types of mature WBCs as well as immature granulocytes.