November 17, 2017
Parsagen Diagnostics, Inc., a women’s healthcare company based at the Harvard Innovation Labs today announced the publication of its first multi-center US clinical trial, alongside other important studies demonstrating the clinical utility of the company’s flagship product: the PartoSure™ test.
Based on the placental alpha microglobulin-1 (PAMG-1) biomarker, the PartoSure test, which is CE marked and not currently approved for sale in the United States, is a novel in vitro diagnostic (IVD) bedside test to aid in the risk assessment of preterm delivery in patients with symptoms of preterm labor.
PartoSure has been shown in several published studies to have a higher positive predictive value when compared to current diagnostic methods, while maintaining an equally high negative predictive value.
In the first and most recent study to be published in the December 2017 issue of Obstetrics & Gynecology, the official journal of the American College of Obstetricians & Gynecologists (ACOG), Wing and colleagues concluded that the PartoSure test was superior to the fetal fibronectin test in predicting preterm birth among symptomatic women, and performed just as well in ruling it out. The investigators went on to state that the PartoSure test may offer a superior solution for clinicians when compared to current methods, since it can be used without a speculum, which increases comfort for the patient and provider.
In a second study published in August 2017 in the Ultrasound in Obstetrics and Gynecology Journal of the International Society of Ultrasound in Obstetrics and Gynecology, investigators compared the performance of PartoSure to fetal fibronectin’s in clinical practice, by retrospectively analyzing their experience over two different time periods at a major European hospital center. Therein, the authors concluded that a positive PartoSure test was over 4 times more reliable than a positive fetal fibronectin test in predicting imminent preterm birth. Further, they posited that when a positive biomarker test’s results are more reliable, this could lead to a reduction in unnecessary hospitalizations, avoidable treatments, and preventable use of hospital resources.
Lastly, in July 2017, the European Association of Perinatal Medicine published its updated Preterm Labor and Birth Management Guidelines, where the PartoSure test’s placental alpha-microglobulin-1 (PAMG-1) was identified as the biomarker test with the highest combination of negative predictive value (NPV) and positive predictive value (PPV) to be used in women with equivocal cervical length measurements between 15 and 30 mm, according to recent literature.
“The data supporting the PartoSure test, now published in several top journals and recognized in European practice guidelines, give clinicians confidence that PartoSure can help better identify patients truly at increased risk of preterm birth in the next few weeks.” said Prof. Carl Weiner, MD MBA, Chair Obstetrics and Gynecology and Division Head of Maternal Fetal Medicine at the University of Kansas Medical School in Kansas City, KS. “Corticosteroids and other antenatal interventions such as tocolytics, magnesium sulphate and antibiotics, are critical if delivery is imminent; but are expensive and potentially harmful if given without a clear indication. The PartoSure test provides information that clinicians need to proactively manage pregnancies at an increased risk.”
“Parsagen Diagnostics is focused on addressing the great burden that preterm birth places on families and healthcare systems globally and we are committed to reducing the impact of this condition around the world.” said Ruben Salinas, President & CEO of Parsagen Diagnostics. “A significant number of pregnant women experience symptoms of threatened preterm labor. However, as few as 3% of them actually progress to delivering within the seven ensuing days. It is a major challenge for clinicians today to predict which women will actually deliver imminently, especially in the absence of clear cervical dilatation or other relevant clinical factors. Discharging patients home creates the risk of a potentially avoidable adverse outcome, yet prophylactically admitting them for observation incurs considerable costs to the healthcare system and disruptions to the mother and family’s life.”
About Premature Birth
According to the March of Dimes, premature birth (birth before 37 weeks of pregnancy) and its complications are the #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.
About Parsagen Diagnostics, Inc.
Parsagen Diagnostics is an early-stage company focused on women’s health that develops next-generation point-of-care diagnostics in the field of high risk obstetrics and prematurity. For more information visit http://parsagendx.com and http://partosure.com.
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