The home-collected vaginal samples can be shipped to CLIA-certified labs for testing on the Roche Cobas system.

Kuppusamy noted that Quest does offer testing, and advanced diagnostic testing in particular, through its Global Diagnostics ...

NEW YORK – Eight German associations are calling for changes to be made to the European In Vitro Diagnostics Regulation (IVDR ...

NEW YORK – Although it had multiple products with regulatory clearance and technology that had been validated by outside users, Accelerate Diagnostics' inability to attract buyers for its instruments ...

Congress has passed delays to PAMA implementation, but such a pause could be less likely this year, warn industry stakeholders.

The agreement enables rapid diagnostic test manufacturing in the Africa region and will initially focus on HIV testing.

Note: This story has been updated with comments from a conference call to discuss the firm's financial results. NEW YORK – Siemens Healthineers said Wednesday that it expects tariffs implemented by ...

The money will support the development of the firm's PidPort system for storage, viewing, sharing, and analysis of digital images of pathology slides.

NEW YORK – Kiffik Biomedical and Rubix LS are working together to combine an interstitial fluid collection device and aptamer biosensing for rapid, at-home, cancer detection at the point of care.