Sera Prognostics said this week that it has completed enrollment of 5,500 women in its Proteomic Assessment of Preterm Risk clinical study supporting the validation of its PreTRM proteomic test for predicting risk of preterm birth.
The company plans to have data from these samples in the fourth quarter of this year with launch of the test likely in 2014. The test had originally been slated for release in the fall of this year but will be delayed due to expansion of the PAPR trial size, the company told ProteoMonitor through a spokesperson.
Conducted at 11 clinical centers across the US, the effort represents the largest proteomic study to date in the US for predicting preterm birth, the company said. It is also one of the largest protein biomarker clinical validation studies ever undertaken using mass spec.
Based on intellectual property licensed from the University of Utah and Brigham Young University, Sera's PreTRM test consists of three proprietary peptides plus six additional proteins. The company plans to offer the panel as a mass spec-based test out its CLIA laboratory (PM 3/1/2013).
"We look forward to completing the final analysis of the PAPR study and validating the performance of our PreTRM predictor," Gregory Critchfield, Sera's chairman and CEO, said in a statement. "This large study provides a strong foundation for Sera’s development of a test that could help address the enormous economic and health consequences of preterm birth, with the ultimate goal of benefiting mothers and newborns worldwide."
There are approximately 525,000 preterm births — defined as birth before 37 weeks of gestation — in the US each year, and according to the March of Dimes, the annual public healthcare cost of caring for preterm infants is more than $26 billion.