Fully Automated HIV-1 Test for Diagnostic Use
Roche Diagnostics has received FDA approval for its new HIV-1 test for diagnostic use. The highly accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully automated HIV-1 diagnostic tool using real-time polymerase chain reaction technology in the United States.
According to Roche, it provides a broader range of viral load data than earlier generation tests, quantifying the amount of virus in the blood from very high to very low levels. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy during the treatment course.
The test is intended to be used in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients.
Steerable Lead Helps Pacemakers Monitor, Regulate
The FDA approved Guidant Corporation's steerable pacemaker leads (Acuity Steerable Lead Models 4554, 4555, 4556). The leads provide a connection between the heart and an implanted cardiac resynchronization pacemaker. This allows the pacemaker to monitor and regulate heart rate.
To enhance electrical conduction within surrounding tissues, a small amount of dexamethasone acetate is briefly released from the lead tip.
The leads are contraindicated in patients sensitive to dexamethasone. They also should not be used in patients with mechanical tricuspid heart valves or in patients with blood vessels that are blocked or inadequate for lead placement.
New Delivery Method Approved for Lantus
Sanofi-Aventis received FDA approval for Lantus SoloStar, a new prefilled disposable insulin pen for once-daily 24-hour insulin glargine (Lantus). Lantus SoloStar is used for the treatment of hyperglycemia in people with type 1 or type 2 diabetes and is the only disposable insulin pen that allows patients to administer doses from 1 to up to 80 units in one injection.
Lantus SoloStar should be kept in cool storage until first use. Once in use, it can be kept at room temperature as long as it remains below 86[degrees]F and away from direct heat or light. It can be used for up to 28 days.
Enzyme Immunoassay Test Detects Hepatitis B Virus
The FDA approved the MONOLISA Anti-HBc Enzyme Immunoassay Test (Bio-Rad Laboratories) for use in the qualitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (anti-HBc) in human serum and plasma.
To perform the test, patient serum or plasma specimens are incubated with microwells coated with recombinant HBc antigen. Antibodies to HBc, if present, bind to the antigen, and the antihuman conjugate is added to the microwells. After an incubation period, samples containing HBc turn tetramethylbenzidine solution from colorless to blue.
New Test Predicts Risk of Breast Cancer Relapse
The FDA approved Agendia BV's (Amsterdam, the Netherlands) Mamma Print gene expression profile test to identify breast cancer relapse risk within 5 to 10 years of initial surgery in breast cancer patients. It is the first test of its kind to be approved in the United States.
Mamma Print uses the latest techniques in molecular technology to predict whether existing cancer will metastasize. The test uses microarray analysis, which simultaneously studies behavioral patterns of large numbers of genes in biological specimens.
The FDA's approval was based on data from a European clinical study showing that the test was effective for predicting the time to distant metastasis in women younger than 61 years with Stage I or II lymph node-negative breast cancer and a tumor size of 5 cm or smaller.