Sera Prognostics this week presented results from a study demonstrating that its protein biomarker panel for preterm birth was able to predict incidence of that complication at 24 and 28 weeks gestation with 92 percent sensitivity and 86 percent specificity.
Based on intellectual property that Sera has licensed from the University of Utah and Brigham Young University, the panel consists of five previously identified proteins plus three proprietary peptides. In January, Sera raised $1.4 million to fund development of the test, which it hopes to launch as a CLIA diagnostic by the end of the year or early 2012 and later submit for approval with the US Food and Drug Administration (PM 01/07/2011).
The company presented the study at the Society for Maternal-Fetal Medicine's annual meeting in San Francisco. It follows a previous study published in the November issue of the American Journal of Obstetrics and Gynecology in which the test demonstrated 86.5 percent sensitivity and 80.6 percent specificity for preterm birth at 28 weeks of pregnancy.
There are approximately 525,000 preterm births in the US each year. According to the March of Dimes, the annual public healthcare cost of caring for preterm infants is more than $26 billion. Currently there are no tests on the market for predicting whether an asymptomatic woman will go on to have an early delivery.