Sera Prognostics has reported top-line data from the AVERT PRETERM TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls) of the PreTRM test-and-treat strategy.

Conducted at ChristianaCare in Wilmington, Delaware, US, the AVERT PRETERM TRIAL assessed the health benefits that babies experienced when pregnancies were screened with the PreTRM Test and doctors used the results to intervene.

Findings showed that the PreTRM test-and-treat strategy met both of the trial’s co-primary outcomes, namely decreased neonatal hospital stay length and reduced severe neonatal morbidity or neonatal death.

The PreTRM test-and-treat strategy also showed statistically and clinically significant improvement in neonatal health outcomes.

Sera Prognostics chairman and CEO Gregory Critchfield said: “The AVERT PRETERM TRIAL results demonstrate the generalisability of the PreTRM test-and-treat strategy in achieving meaningful clinical results in widely diverse US populations.

“Furthermore, these important AVERT PRETERM TRIAL clinical results build on and reinforce those of past studies- including PAPR, TREETOP and PREVENT-PTB.

“We believe the AVERT PRETERM TRIAL findings add to the growing body of evidence for the PreTRM Test’s clinical benefit to mothers and babies, and that these new results bode well for our ongoing, large multi-centre PRIME study.”

The PreTRM Test is designed to predict spontaneous premature delivery during pregnancy. This enables earlier proactive interventions in patients with increased risk.

It was validated in the Proteomic Assessment of Preterm Risk (PAPR) study in the US.

The PreTRM Test was also validated in the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP), a subsequent large prospective study conducted in the country.

In the TREETOP trial, the biomarkers were found to predict very early preterm birth due to any cause, composite neonatal morbidity/mortality, and neonatal length of hospital stay.