Clinical laboratories in the US and Europe are facing pressure from all sides as budget cuts and staffing shortages compete with a growing demand for ever-more-sophisticated lab tests to serve an aging population. As a result, lab directors are seeking innovative ways to improve efficiency and do more with less, and those goals are driving innovation in technology-based solutions such as laboratory automation and informatics. These solutions are increasingly becoming integrated into the total laboratory process – encompassing not only sample analysis, but also up- and downstream workflows – paving the way for the fully integrated, automated lab of the future.

Laboratory-developed tests are not explicitly mentioned in FDA’s 12-page draft guidance on companion diagnostics issued this summer, but the issue attracted significant attention in written comments in response to the document.

FDA's draft guidance on the development of companion diagnostics for drug therapies, released July 12, delivers on a promise to publicly outline how it will address review of those products, but at only 12 pages, it has left some in industry longing for more insight.