QIAGEN Announces FDA Approval of PartoSureTM
April 20 2018 - 2:00AM
Business Wire
Novel point-of-care test to assess risk of
spontaneous preterm birth, reducing unnecessary hospital admissions
and safeguarding babies
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced the U.S. regulatory approval of PartoSureTM , 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 U.S. Food and Drug Administration (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.
PartoSure represents a key milestone in the development of
diagnostic tests for preterm birth. 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.
PartoSure adds to QIAGEN’s comprehensive Sexual and Reproductive
Health portfolio, which includes the AmniSure® ROM Test, the
world’s leading assay for rupture of membranes (ROM);
differentiated core technologies and bioinformatics solutions for
non-invasive prenatal testing (NIPT); and the “gold standard”
digene HC2 HPV Test to screen for human papillomavirus (HPV) and
protect women from cervical cancer. The combination of PartoSure
and AmniSure gives QIAGEN two highly synergistic, biomarker
targeted diagnostics for assessing the risk of two critical aspects
of prenatal labor management. Both tests are leveraging the ability
to assess respective risks quickly without the requirement of a
reader.
Please find the full press release here
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version on businesswire.com: https://www.businesswire.com/news/home/20180419006112/en/
QIAGENInvestor RelationsJohn Gilardi+49 2103 29
11711e-mail: ir@QIAGEN.comorPublic RelationsDr. Thomas
Theuringer+49 2103 29 11826e-mail: pr@QIAGEN.com
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