February 3, 2021
Sera Prognostics, Inc., The Pregnancy Company™, focused on improving maternal and neonatal health through innovative precision biomarker approaches, announced today that the American Medical Association (AMA) has assigned a new, dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA) code to facilitate billing and payment for the PreTRM® Test, the company’s proprietary proteomic blood test for measuring a woman’s risk of spontaneous preterm birth to enable timely intervention.
The establishment of the new code, 0247U, is a result of the AMA’s PLA program, which enables labs with distinct, single-source Laboratory Developed Tests (LDT) to apply for a dedicated code that can be utilized to bill payors in order to receive reimbursement. This code is included in the revised set of PLA codes the AMA released on December 30, 2020, with an effective date of April 1, 2021.
The new code, 0247U, is associated with an official Descriptor that 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, it 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,” said Gregory C. Critchfield, MD, MS, chairman and chief executive officer of Sera Prognostics. “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. This CPT® PLA code is a step in our ongoing efforts to secure reimbursement from individual employer-sponsored, commercial and Medicaid health plans, an essential component of our business and market access strategies.”
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. Identifying higher-risk pregnancies by PreTRM® enables resources to be more efficiently focused on pregnancies that are at the greatest risk of adverse neonatal outcomes.
The PreTRM® Test is the only broadly clinically validated, commercially available blood test that provides an early individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM® Test measures and analyzes proteins in the blood that are highly predictive of preterm birth.
The PreTRM® Test permits physicians to identify, as early as 19 weeks of pregnancy, which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk, so that her care can be personalized to address her risk. The PreTRM® Test is ordered by a medical professional.