CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.

Owkin announced on Tuesday that it entered into a collaboration with MSD — known as Merck in the US and Canada — to develop and commercialize microsatellite instability high (MSI-H) diagnostics for four types of cancer.

Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations.

The immunoassay market has been the main driven force for the development of the in vitro diagnostics industry in recent years.

Euroimmun, a Revvity company, and Xpedite Diagnostics have partnered to offer DNA extraction protocols for point-of-care diagnostics.

Today, Illumina, Inc. (NASDAQ: ILMN) announced that the company will divest GRAIL.

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.