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FDA Approves Qiagen's Preterm Birth Risk Test

NEW YORK (360Dx) – Qiagen announced today that the US Food and Drug Administration approved the company's test for assessing the risk of spontaneous preterm birth in patients with preterm labor symptoms.

PartoSure includes a noninvasive strip test that detects placental alpha microglobulin in patients. It provides results in five minutes or less, and, said Qiagen, studies have demonstrated that, compared with current diagnostic methods, the test has a higher positive predictive value for preterm birth while maintaining an equally high negative predictive value.

PartoSure is already used in 35 countries in Europe, the Middle East, Asia, and Latin America, Qiagen said, adding it anticipates commercializing the test in the US sometime this year.