Chlamydia and Gonorrhea Test Gets Nod
FDA granted Roche clearance to market its cobas CT/NG Test to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections in both symptomatic and asymptomatic patients from male urine and self-collected vaginal swabs. The polymerase chain reaction, multiplex, dual-probe test runs on the company's automated cobas 4800 System.
FDA Rolls Out Plan to Avoid Heparin Contamination
FDA posted draft guidance for drug makers in an effort to help manufacturers of active ingredients and finished products avoid contamination of heparin. The agency's action comes 4 years after a contamination involving the widely used blood-clot prevention drug set off concerns about the global pharmaceutical supply chain. FDA’s recommendations include testing for the species origin and the presence of oversulfated chondroitin sulfate in crude heparin.
Alere Obtains Clearance and CLIA Waiver for Influenza Test
Alere received FDA clearance and a CLIA waiver for its new test to detect influenza A and B. The Alere Influenza A&B Test uses highly sensitive antibodies to identity influenza types A and B antigen. The rapid test is intended for use in physician's offices to aid in managing patients with influenza-like illnesses.
Quest Gets Green Light to Market Test for PML Risk in MS Patients
FDA permitted Quest Diagnostics to market its Stratify JCV Antibody ELISA test. The test is the first assay designed to aid in determining the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people taking the drug Tysabri (natalizumab), a treatment for multiple sclerosis or Crohn's disease.