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Qiagen N.V.. (4/20/18). "Press Release: Qiagen Announces FDA Approval of PartoSure". Germantown, MD & Hilden.

Region Region United States (USA)
Organisations Organisation Qiagen N.V.
  Group Qiagen (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product PartoSure® test
  Product 2 AmniSure® rapid ROM test
Person Person Bernard, Thierry (Qiagen 201502– SVP Molecular Dx business area before bioMérieux Corp VP Commcercial Operations)
     


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 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 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.

According to the March of Dimes, premature birth (before 37 weeks of pregnancy) and its complications are the No. 1 cause of death of babies in the United States. Babies who survive premature birth often have long-term health problems, including cerebral palsy, intellectual disabilities, chronic lung disease, blindness, and hearing loss. In the United States, about 380,000 babies are born prematurely each year.

“Preterm birth is a global condition that has a dramatic impact in the United States, where about one in 10 babies are premature and the cost of preterm births and complications is estimated at more than $26 billion a year. The FDA-approved PartoSure test will help clinicians assess which mothers face an imminent risk of preterm birth, which should reduce healthcare costs and benefit patients,” said Thierry Bernard, Senior Vice President and head of QIAGEN’s Molecular Diagnostics Business Area. “While a significant number of pregnant women experience symptoms of threatened preterm labor, as few as 3% actually progress to giving birth within a week of testing. Clinicians struggle to predict which symptomatic women will give birth prematurely and to decide on appropriate care. Discharging these patients carries a risk of a preterm delivery outside of the hospital, but admitting them always incurs considerable costs and disruptions to the family – often unnecessarily. PartoSure has been proven to reduce the uncertainty.”

The PartoSure test, already is widely accepted for assessing risk of preterm birth in more than 35 countries across Europe, the Middle East, Asia and Latin America. The European Association of Perinatal Medicine’s Preterm Labor and Birth Management Guidelines identify PartoSure’s PAMG-1 as the biomarker with the highest combination of negative predictive value (NPV) and positive predictive value (PPV).(1)

Several peer-reviewed publications have supported the performance of the PartoSure test, most recently a study in the December 2017 issue of Obstetrics & Gynecology(2), the journal of the American College of Obstetricians & Gynecologists (ACOG). In this study, investigators concluded that a positive PartoSure test was significantly better at assessing the risk for preterm birth among symptomatic women than a positive fetal fibronectin test, the only other FDA-approved test for helping to assess the risk of preterm delivery in symptomatic women. The authors also highlighted several practical advantages of the PartoSure test including the capability to rapidly test specimens collected after prior intercourse or vaginal examination, without the requirement for a speculum examination or the need for reading the test on an instrument – all of which can cause risky delays as well as inconvenience.

In a study published in August 2017 in Ultrasound in Obstetrics and Gynecology, the Journal of the International Society of Ultrasound in Obstetrics and Gynecology, investigators compared the performance of PartoSure to fetal fibronectin tests in real-world clinical practice.(3) The authors concluded that a positive PartoSure test was more than four times as reliable as a positive fetal fibronectin test in predicting imminent preterm birth, an advantage that may lead to reductions in unnecessary hospitalizations, avoidable treatments, and preventable use of hospital resources.


1 Di Renzo GC, Cabero Roura L, Facchinetti F et al. Preterm Labor and Birth Management: Recommendations from the European Association of Perinatal Medicine. J Matern Fetal Neonatal Med. 2017 Sep;30(17):2011-30.

2 Wing DA, Haeri S, Silber AC, et al. Placental alpha microglobulin-1 compared with fetal fibronectin to predict preterm delivery in symptomatic women. Obstet Gynecol 2017 Nov 3. [Epub ahead of print]

3 Melchor JC, Navas H, Marcos M, et al. Retrospective cohort study of PAMG-1 and fetal fibronectin test performance in assessing spontaneous preterm birth risk in symptomatic women attending an emergency obstetrical unit. Ultrasound Obstet Gynecol 2017 Aug 29. [Epub ahead of print].


About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, QIAGEN employed approximately 4,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.


Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

   
Record changed: 2018-05-01

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