AMA Creates New PLA Code 0247U for Sera Prognostics PreTRM Test

The most recent laboratory developed test (LDT) to garner CPT code recognition from the American Medical Association (AMA) is Sera Prognostics, Inc.’s PreTRM Test, a proteomic blood test for measuring a woman’s risk of spontaneous preterm birth in time to allow for timely intervention. The new code 0247U, which was established under the AMA’s Proprietary Laboratory Analysis (PLA) code program, was part of the revised set of PLA codes that took effect on April 1, 2021.

New PLA Code 0247U

The official Descriptor associated with new code 0247U states: “Obstetrics (preterm birth), insulin-like growth factor-binding protein 4 (IBP4), sex hormone-binding globulin (SHBG), quantitative measurement by LC-MS/MS, utilizing maternal serum, combined with clinical data, reported as predictive-risk stratification for spontaneous preterm birth.” As such, the Descriptor is specific to the PreTRM Test.

“The receipt of this dedicated CPT PLA code is an important milestone in our commercial strategy to establish coding, coverage and payment for our proprietary PreTRM Test,” Sera Prognostics chairman and CEO Gregory C. Critchfield, MD, MS. “We believe that the PreTRM® Test has an important role to play to improve risk identification that allows earlier proactive interventions designed to decrease adverse outcomes and thereby reduce healthcare costs. We are committed to making the test broadly accessible.”

Preterm birth is a leading cause of illness and death in newborns. The PreTRM Test provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies, according to a company statement.