Genetic Technologies said that it will offer its test for the risk of cancers and other chronic diseases through Stayhealthy's online discount pharmacy.

The Liaison Plex Yeast Blood Culture Assay is used for the detection of 16 pathogens that are commonly associated with fungal bloodstream infections.

Pathology directors expect that they will be unable to send out or receive samples for new tests when the FDA's new LDT rule ...

The Australian molecular diagnostics firm's PCR-based assay is used to identify infections with eight of the most common and clinically relevant GI parasites.

The system, which was submitted to the FDA for clearance about a year ago, is designed to provide quantitative IgE testing in allergy clinics.

Of the 30 companies in the list, 19 companies saw their share prices rise, while 11 firms saw their stock prices decline.

Last week, readers were most interested in a story about ACLA suing the FDA, as anticipated, over its final rule to regulate LDTs.

The firm said that each American Depositary Share is now worth 10 Class A ordinary shares compared to a previous value of one ADS per Class A ordinary share.

Company executives noted that the firm has plans to launch approximately 125 new tests in the next three years.

The updated regulations, which went into effect in January, reverse a previous CMS policy that had drawn broad opposition ...

NEW YORK – Biolabs International announced Thursday that its exclusive distribution partner, Watmind USA, has obtained Emergency Use Authorizations from the US Food and Drug Administration for ...

The companies will jointly develop next-generation sequencing-based companion diagnostic tests for Bayer's precision cancer therapies.