Digene's DNA test for gonorrhea cleared in US:
This article was originally published in Clinica
The US FDA has cleared Digene's test for Neisseria gonorrhea DNA in cervical specimens from women with or without symptoms of the infection. The test is a signal amplified nucleic acid hybridisation assay that uses the same gene analysis technology employed in Digene's other women's cancer and infectious disease diagnostics. A common collection device will allow tests for human papilloma virus (HPV), chlamydia and gonorrhea to be performed on a single specimen, said Beltsville, Maryland-based Digene. The Hybrid Capture II gonorrhea test will be distributed by Abbott Laboratories, which also distributes the test in Europe, Africa and the Middle East.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.