LabCorp launches PreTRM test to assess risk of preterm birth

May 23, 2017 – BURLINGTON. LabCorp® today announced the nationwide availability of the PreTRM® test. Developed by Sera Prognostics, Inc., the PreTRM test is the first of its kind validated blood test that provides an early and individualized prediction of preterm birth risk for pregnant women. LabCorp and Sera previously announced their strategic collaboration for LabCorp to be the exclusive U.S. distributor of Sera’s PreTRM test. LabCorp was also a lead investor in Sera’s recently closed Series C financing round.

“As the exclusive U.S. laboratory to offer Sera’s PreTRM test, LabCorp continues to build a leading position in women’s and reproductive health diagnostics,” said Gary M. Huff, chief executive officer of LabCorp Diagnostics. “We are excited about our collaboration with Sera, and this innovative test is part of our ongoing strategy to deliver world-class diagnostics that can improve health and lives.”

The PreTRM test is performed on a standard blood specimen collected during weeks 19 and 20 of pregnancy. The specimen must be collected at one of LabCorp’s over 1,750 patient service centers.

The test can help physicians provide better care by helping to predict the risk of preterm birth, providing the opportunity to intervene earlier to help extend the pregnancy towards full-term. Preterm birth is the leading cause of infant mortality and morbidity in the U.S. and worldwide. Approximately 400,000 of the 4,000,000 annual births in the U.S. are preterm, defined as prior to week 37 of pregnancy, and up to 50 percent of women who delivery prematurely do not have any identified risk factors for preterm birth. According to the March of Dimes, the average cost of care for a premature baby is ten times the average cost for a full-term baby. Children born prematurely can require long-term or lifetime care, with significant additional cost. Each additional week towards full-term pregnancy can help to prevent mortality, improve a variety of health outcomes, including respiratory and neurodevelopmental outcomes, and eliminate or reduce the expense and impact of caring for a preterm infant.

The PreTRM test was supported by the landmark Proteomic Assessment of Preterm Risk study, which followed over 5,500 pregnant women, analyzed over 300 proteins in maternal blood and identified a two-protein signature that was found to be highly predictive of spontaneous preterm birth. The test is a significant addition to LabCorp’s differentiated women’s healthcare and reproductive genetics offerings. These include MaterniT®21, a proprietary, clinically validated non-invasive prenatal test, and the industry’s largest network of genetic counselors who can help patients understand genetic test results. In addition, LabCorp offers patient-focused services such as support to obtain insurance pre-authorization before a test is performed and a personalized estimate of the out-of-pocket cost of services before specimen collection by LabCorp.

The PreTRM test is the first of its kind validated blood test that provides an early and 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 can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk. The PreTRM test enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health. The PreTRM test is ordered by a medical professional.

Source: Laboratory Corporation of America(R) Holdings