PartoSure

The PartoSure Test is CE marked and is currently investigational use only in the United States. Parsagen Diagnostics, Inc. is the manufacturer of PartoSure™, a novel bedside test to aid in the assessment of preterm delivery in patients with symptoms of preterm labor. Based on the detection of PAMG-1, PartoSure has been shown in published studies to have a higher positive predictive value compared to current methods, while maintaining an equally high negative predictive value. Preterm birth has proven to be a major diagnostic challenge, until now. Clinical evaluation alone, including the measurement of cervical length and dilatation, is not sufficiently predictive of imminent delivery among patients with signs of threatened preterm labour. Similarly, currently available biomarker tests, such as that which is based on the detection of fetal fibronectin (fFN), have extremely poor positive predictive values for imminent delivery. Because of this, 85% of patients admitted to the hospital for threatened preterm labour do not even deliver within the next 7 days, costing hospitals up to 8,000 €. However, the PartoSure test has proven to be a superior test for assessing a patient's risk for preterm birth across various studies and geographies. The test is a rapid, non-invasive strip test for the detection of placental alpha microglobulin-1 (PAMG-1) in patients presenting with signs and symptoms of preterm labour. PartoSure's unique features include: High Positive (PPV) and Negative Predictive Value (NPV); usable shortly after vaginal exam; speculum examination optional; results in 5 minutes or less; no special equipment or training needed; wide gestational age range from 20 to 37 weeks. The test is most useful in cases where cervical length (CL) is between 15 and 30 mm where the predictive value of CL is lowest. While a CL-cutoff of 25 mm is often utilized, up to 1 in 8 women with a CL between 25-30 mm will deliver within the next 7 days.

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• Founded 2012