This site is intended for healthcare professionals
  • Home
  • /
  • News
  • /
  • 2018
  • /
  • 04
  • /
  • FDA approves PartoSure diagnostic to assess risk o...
Drug news

FDA approves PartoSure diagnostic to assess risk of spontaneous preterm birth.- Qiagen.

Read time: 1 mins
Last updated:21st Apr 2018
Published:21st Apr 2018
Source: Pharmawand

Qiagen announced the U.S. regulatory approval of PartoSure, which is a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The pre-market approval of PartoSure by the FDA follows successful uptake of the rapid, accurate test in more than 35 countries across Europe, the Middle East, Asia and Latin America. U.S. commercialization of the PartoSure test is expected to begin in 2018.

A non-invasive strip test that provides results in five minutes or less, PartoSure has been shown in several published studies to have a higher positive predictive value for preterm birth compared to current diagnostic methods, while maintaining an equally high negative predictive value. The novel test detects placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labor.

Comment: PartoSure was CE mark approved in the EU in 2013.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.