Digene's papillomavirus test cleared in US:
This article was originally published in Clinica
The FDA has given marketing clearance for Digene's Hybrid Capture II, a DNA-based test for the human papillomavirus (HPV) - the cause of almost all cervical cancer. Dr Attila Lorincz, scientific director of the Beltsville, Maryland-based company, said that the test: "detects up to 90% to 95% of high grade cervical disease. The Pap smear, on the other hand, may miss 20% to 30% of cervical cancers and their pre-malignant lesions." Studies in progress should reveal whether or not supplementing Pap smears with HPV testing not only prevents women with treatable disease being missed, but also allows smears to be done less frequently, thereby reducing the cost of screening.
You may also be interested in...
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.