Female condom given approval
The FDA's Obstetrics and Gynecology Devices Advisory Committee has unanimously voted that the Female Health Company's (Chicago, Ill) FC2 female condom is approved with one condition; instructions for use must continue to follow use instructions for the FC1 (first generation) female condom and appropriately identify the study that was performed to establish the second-generation FC2 condom's comparable safety and effectiveness with FC1.
According to the Female Health Company, the FC2 is a low-cost option in the fight against unintended pregnancy, AIDS, and sexually transmitted diseases. The committee's advisors found that the FC2, which is similar to the FC1, has a failure rate equivalent to the FC1.
The company notes that the FC Female Condom is the first and only female-initiated barrier method that is safe and effective if used correctly and consistently, and is highly accepted by both men and women.
First NAT to screen for other HIV types
The FDA approved Roche Molecular Systems Inc.'s (Pleasanton, CA) cobas TaqScreen MPX test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue. The new test detects nucleic acid from HIV-2 and from HIV-1 Group O. HIV-2 infections and HIV-1 Group O infections are predominantly found on the African continent. Some cases of infection with these two types of viruses have also been detected in the United States.
The test also simultaneously detects nucleic acid from the most common form of HIV, HIV-1 Group M, as well as the hepatitis C and hepatitis B virus. The test is designed for use with plasma specimens from human donors of whole blood and blood components, and for tissue specimens obtained while the donor's heart is still beating.
The cobas TaqScreen MPX test runs on Roche Molecular System's fully automated cobas s 201 system.
New test IDs E. coli and P. aeruginosa
AdvanDx (Woburn, MA, and Vedbaek, Denmark) received FDA approval for its Escherichia coli/ Pseudomonas aeruginosa PNA FISH test to identify E. coli and P. aeruginosa directly from positive blood cultures. It is the first-ever test for identifying E. coli and P. aeruginosa directly from blood cultures and the latest addition to AdvanDx's easy to use, molecular-based PNA FISH diagnostics platform. PNA FISH tests now provide rapid species ID for the vast majority of Gram stain results in hours instead of days, enabling therapy-guiding results for 95% to 99% of patients with positive blood cultures.
Patients with blood stream infections caused by gram-negative pathogens such as E. coli and P. aeruginosa have long hospital stays and high mortality rates. This is due in part to the increasing resistance of gram-negative pathogens and the fact that conventional lab testing methods for gram-negative pathogens take 24 to 48 hours to provide results. This forces clinicians to treat patients empirically, which may not provide full coverage for the infecting pathogen. Providing a "head start" on appropriate narrow-spectrum therapy for gram-negative bloodstream infections may improve clinical outcomes and reduce resistance rates.
New test diagnoses C. difficile infections
BD Diagnostics (San Diego, CA) has received FDA clearance for its BD GeneOhm Cdiff molecular assay for the rapid detection of the Toxin B gene found in nearly all toxigenic Clostridium difficile. It is the first C. difficile infection (CDI) molecular diagnostic that offers sensitivity, simplicity, and speed in a one-test procedure.
The stool test allows same-day identification of toxigenic C. difficile, and should improve patient care because it gives labs the option of a single assay that will markedly reduce or eliminate the need for multiple screening and confirmatory tests. Reduced wait time will lead to earlier implementation of infection control interventions that help prevent the transmission of the pathogen to other patients.