Blood-based, Proteomic Test May ID Preterm Delivery Risk, Saving Infant Lives, Costs

The use of a novel test for identifying pregnant women at risk of spontaneous preterm birth risk could improve infant outcomes and reduce the overall economic impact of preterm birth, according to a study published in the December 2016 issue of the American Journal of Perinatology Reports.

The PreTRM test by Sera Prognostics (Salt Lake City) analyzes maternal blood using liquid chromatography-tandem mass spectrometry as early as 19 weeks of gestation. The proteomic test simultaneously measures multiple proteins associated with preterm birth, including those tied to inflammation, hemorrhage, stress, and uterine over-distention. The test developers say that identifying women at risk for premature delivery enables individualized and informed clinical care.

Approximately one in 10 babies born in the United States is premature (born before 37 weeks gestation), which is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss. These complications are costly, estimated to be an average of $54,194 in medical cost per preterm baby (roughly 10 times the cost for a full-term baby).

In the present study, the researchers developed a decision-analytic model to assess clinical and cost outcomes over a one-year period based a hypothetical population of 3,528,593 pregnant women with a singleton gestation and no history of spontaneous preterm birth. The PreTRM test was hypothetically applied to women in the predictive arm and compared to a hypothetical cohort using the current standard of care and baseline rates of spontaneous preterm birth and associated infant morbidity and mortality (baseline care arm). The model assumed 80 percent for both test sensitivity and specificity, as well as a $1,250 cost for the test (based upon cost for noninvasive prenatal testing at launch).

The researchers found that the model predicted a 23.5 percent reduction in infant mortality (approximately 2,000 fewer neonatal deaths per year) with use of the novel test. The rate of acute conditions at birth decreased from 11.2 percent to 8.1 percent. Similarly, the rate of developmental disabilities decreased from 13.2 percent to 11.5 percent. The rate of spontaneous preterm birth decreased from 9.8 percent to 9.1 percent, translating to roughly 23,430 preterm births. On average, 6.8 percent of births that would have been preterm in the baseline arm shifted to full term in the predictive arm.

Additionally, the researchers identified a direct medical cost savings of $511.7 million, a decline of 2.1 percent during the first year of life. The cost-benefit analysis demonstrated overall total cost savings (direct and total costs) of $1.49B through hypothetical use of the test in the predictive arm. These direct medical cost savings were realized due to a decrease in hospitalization and rehospitalization costs resulting from increasing the average gestational age.

Takeaway: A novel, proteomic blood test may identify women at increased risk of spontaneous, preterm delivery. Through identification of these women and early intervention, improvements in infant outcomes and costs may be achieved.