Laboratory Corporation of America Holdings (LabCorp) has entered into a strategic collaboration to be the exclusive US distributor of the PreTRM test from Sera Prognostics Inc, Salt Lake City. PreTRM is the first clinically validated blood test that provides an early and individualized prediction of preterm birth risk.
In addition, LabCorp will lead Sera’s $40 million Series C financing. Proceeds from the Series C financing, which includes existing investors, will enable Sera to continue building clinical evidence to support reimbursement and insurance coverage decisions, as well as expand commercialization nationwide for the PreTRM test. Sera plans to leverage LabCorp’s market position in noninvasive prenatal testing (NIPT), women’s healthcare, and reproductive genetics, and its nationwide network of 1,750 patient service centers, to make PreTRM broadly accessible to physicians and patients concerned about preterm birth risk.
The PreTRM test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The 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 test enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health. The test is ordered by a medical professional.
“We are very excited to enter into this collaboration with LabCorp to expand our reach in the maternal fetal medicine community, enabling us to further educate both physicians and patients on the value of knowing the risk, early in pregnancy, of premature birth,” says Gregory C. Critchfield, MD, MS, chairman and chief executive officer of Sera Prognostics. “As highlighted by two recent publications, experts state that use of biomarker testing is ‘a dominant strategy’ for addressing the negative impact of prematurity. We are confident that with this financing and collaboration, Sera can realize its vision of improving neonatal health and associated economics in the United States and worldwide.”1,2,3
Sera initiated a targeted launch of PreTRM with limited commercial access in select geographies in 2016 and will expand the test’s availability nationwide in 2017 in partnership with LabCorp.
“Sera’s PreTRM test is a unique offering and one that has the potential to change the way prematurity is identified and treated today,” says David P. King, chairman and chief executive officer of LabCorp. “The collaboration with Sera expands our ability to provide patients and physicians with one source for the most complete range of testing options in women’s health, in support of our mission to improve health and improve lives.”
“As a market leader in NIPT, women’s health, and reproductive genetics, LabCorp brings a significant depth of experience that will help expand the commercialization of PreTRM,” says Critchfield. “Together, we are working toward reducing the social and economic burden of prematurity by more accurately predicting preterm birth risk and providing both physicians and patients the opportunity to intervene earlier to address prematurity risk, with the goal of improving the lives of women and their babies.”
For more information, visit Sera Prognostics.
- Two peer-reviewed publications highlight clinical utility of PreTRM test [press release, online]. Salt Lake City: Sera Prognostics, Available at: www.seraprognostics.com/two-peer-reviewed-publications-highlight-clinical-utility-of-pretrm-test. Accessed February 23, 2017.
- Caughey AB, Zupancic JA, Greenberg JM, et al. Clinical and cost impact analysis of a novel prognostic test for early detection of preterm birth. AJP Reports. 2016;6(04):e407–e416; doi: 10.1055/s-0036-1593866.
- Sullivan SA, Hoffman M, and Elliott J. Preterm birth: can we do better? POG. 2016;6(3):1–17.