The UK-based firm has issued five Class II recalls for its RX-series analyzers since 2018 for issues related to reagent carryover between subsequent tests.

NEW YORK — Owlstone Medical, a UK-based developer of breath-based diagnostics, said on Wednesday that it has closed a $27 million Series E financing round.

The test detects HIV-1/2 antibodies in finger prick samples and is intended for use by healthcare professionals in any healthcare setting.

The firm said preliminary core Q4 2024 revenues are expected to be flat, exceeding prior expectations, while its China business has stabilized and will recover.

The report also indicates that while PAMA has cut spending on routine tests, overall lab spending has risen as genetic testing continues to grow.

The recent clearance and a previous clearance together allow the use of Paige's FullFocus digital pathology image viewing software with scanners by Philips, Leica, and Hamamatsu.

Highlights from the first day included updates from Exact Sciences about its plans for new tests slated for this year and ...

NEW YORK – Pathology software developer Aiosyn said recently that it has gained CE marking for an algorithm that is used for mitotic figure counting in breast cancer diagnostics. The Nijmegen, ...

The reagents are meant for measuring aCL and aβ2GP1 antibody levels in human serum to aid the diagnosis of primary and secondary APS.

Following OraSure's November 2024 lawsuit accusing NowDx of misappropriating trade secrets, NowDx has countersued OraSure over similar allegations.

The company received conditional approval from New York state for its new systemic lupus erythematosus and rheumatoid arthritis biomarker assays.

Numerous firms reported preliminary revenues along with other business updates on Sunday and Monday ahead of the annual JP Morgan Healthcare Conference.