Drug-Diagnostic Collaborations.  Monogram Biosciences launched its Trofile HIV diagnostic, the same day as FDA approval of Pfizer's first-in-class (CCR5 antagonist) HIV drug Selzentry (maraviroc). The assay identifies candidates for treatment with Selzentry, which blocks entry of HIV into uninfected cells.  This is a new business strategy for diagnostic test firms - supplying a companion diagnostic to a pharmaceutical company for the drug development process and then relying on the success of the drug to drive test sales.  The approved drug labeling specifically instructs physicians to test patients for CCR5-tropic HIV - virus that has the ability enter cells via the receptor that Selzentry blocks - before prescribing the drug.  Trofile is the only available CCR5 tropism test.  FDA is in the process of developing guidelines to help companies co-develop drugs and diagnostics.  Additional information is available at  http://www.thegraysheet.com (paid subscription service).

Call For Study On Device-Related Infections.  A section of the House FDA user fee bill (H.R. 2900) calls for a study on hospital-acquired infections attributable to new and reused medical devices.  It asks the GAO to report on the number and causes of such infections. Specifically, it directs GAO to consider reprocessed single-use devices, and handling of sterilized devices, as well as in-hospital device sterilization.  As the Senate version of the FDA bill lacks this provision, the two bills will have to be reconciled when Congress reconvenes.  The provision sponsor says "these devices were designed for optimal performance and safety under their intended conditions of use, not necessarily designed for their ease of cleaning and even secondary use, which makes it extremely difficult to effectively clean and resterilize."  He cited a Centers for Disease Control and Prevention report that said that preventing such infections could save more than 90,000 lives and $50 billion annually.  The reprocessing industry supports the study, and says that the reprocessing industry has an excellent safety record, and is not concerned that reprocessed devices will be identified as a source of nosocomial infections.  GAO has been studying third-party reprocessing since January 2006 at the request of House Oversight Committee leaders Tom Davis (R-Va.) and Henry Waxman (D-Calif.).  Additional information is available at  http://www.thegraysheet.com (paid subscription service).

Lyme Disease Tests Under Investigation.  Scientists are calling for a test that can identify when the bacteria causing Lyme disease is active in the body.  Current tests only identify antibodies.  Early stage detection could give patients more successful treatment options.  Tools currently under investigation include an antibody test that could track treatment response and brain imaging that could tell when Lyme penetrates the nervous system.  The CDC estimates that 20,000 new cases of Lyme disease are reported each year.  The true figure may be five times higher due to unreported cases.  Additional information is available at http://www.devicelink.com/mddi/blog/?p=458.