Diagnostic Agents

Trio all-in-one blood glucose meters

Pepex Biomedical announced the development of Trio, a multi-function, single-unit blood glucose meter product line, which tests blood glucose levels and delivers insulin.

xTAG CYP2D6 Kit pharmacogenetic test launched

Luminex announced that it has launched its pharmacogenetic test, the xTAG CYP2D6 Kit, which is approved by the FDA to help identify individuals who possess both common and rare CYP2D6 poor-metabolizer variants.

Aridol Bronchial Challenge Test Kit approved

The FDA has approved Aridol (mannitol inhalation powder, from Pharmaxis) Bronchial Challenge Test Kit for the assessment of bronchial hyperresponsiveness in patients ≥6 years of age who do not have clinically apparent asthma.

New warnings for gadolinium-based contrast agents

The FDA is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of nephrogenic systemic fibrosis (NSF), a rare and potentially fatal condition, if the drug is administered to certain patients with kidney disease.

Abbott RealTime HBV test approved

Abbott announced that the FDA has approved its RealTime HBV assay for measuring the amount of hepatitis B virus (HBV) in human plasma or serum from individuals chronically infected with HBV.

Cysview approved for cystoscopic detection of papillary bladder cancer

The FDA has approved Cysview (hexaminolevulinate HCl, from GE Healthcare), an optical imaging agent, for use in the cystoscopic detection of non-muscle-invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.