#USA #Salt Lake City #Sera Prognostics #PreTRM Test #neonatal health

Groundbreaking Study on PreTRM® Blood Test

Recent research published in the journal PREGNANCY has unveiled significant advantages of the PreTRM® blood test in decreasing preterm births and enhancing outcomes for newborns. The PRIME Study, which involved a randomized controlled trial with 5,018 women, demonstrated that when this simple blood test is utilized alongside targeted interventions, it considerably reduces the risk of preterm deliveries and associated complications for infants.

Key Findings

Among the remarkable results noted in this study are:

• - A 56% reduction in births before 32 weeks and a 32% reduction before 35 weeks.
• - A 20% decrease in neonatal intensive care unit (NICU) admissions.
• - A significant drop (20%) in the odds of newborn health complications.
• - The study found that one day in the NICU was saved for every 4.2 women screened.

These findings emphasize the effectiveness of the PreTRM Test in pinpointing women at heightened risk for spontaneous preterm birth. The test facilitates tailored preventive care measures, leading to improved health results.

Understanding the PreTRM Test

The PreTRM Test is characterized as a pioneering, personalized, and non-invasive blood test designed to forecast the risk of spontaneous preterm birth among asymptomatic women carrying a single child. Women identified as high-risk through the test benefitted from comprehensive interventions, which included daily vaginal progesterone treatment, low-dose aspirin, and supportive care from nurses. In contrast, lower-risk participants received standard prenatal care.

Dr. Brian Iriye, the principal investigator of the PRIME study, stated, "The PreTRM Test represents a significant advancement in our approach to identifying and managing the risk of preterm birth. Many women who ultimately deliver prematurely are misclassified as 'low risk' based on traditional criteria — a discrepancy that is unacceptable. By quantifying a woman’s biological risk early in her pregnancy, we can replace guesswork with a straightforward, evidence-based care plan aimed at supporting mothers and protecting their infants."

Broader Implications

Zhenya Lindgardt, President and CEO of Sera Prognostics, remarked on the findings, saying, "These results not only reinforce the impressive outcomes observed in the AVERT PRETERM Trial, but they also enhance our capacity to build a solid body of clinical evidence supporting the PreTRM test-and-treat strategy. With preterm birth affecting approximately one in every ten infants in the U.S., our commitment is to extend beyond innovative solutions like the PreTRM Test to foster education, access to care, and awareness."

The repercussions of preterm births are profound, both in terms of health complications for newborns and the economic burden on health systems. By addressing these issues through such innovative testing, Sera Prognostics aims to redefine standards of care that deliver tangible benefits to patients and providers.

Future Discussions

A fireside chat involving Dr. Brian Iriye, Zhenya Lindgardt, and Dr. Tiffany Inglis, the Chief Medical Officer of Sera, is scheduled to take place on January 9, 2026, at 8:30 a.m. Eastern Time, where they will delve further into the detailed results of the PRIME study. Interested parties are encouraged to contact their Jefferies sales representative for further participation details.

Conclusion

The significance of the PreTRM Test extends far beyond individual patient care; it signifies a game-changing advancement in prenatal health, particularly for women who are otherwise classified as low-risk by conventional criteria. By leveraging personalized testing methods, we can substantially improve the landscape of maternal and neonatal health outcomes, ensuring that every baby receives the best possible start to life.