According to the National Institute for Children’s Health Quality, “Ten percent of babies in the United States are born prematurely, facing increased risks of health issues and complications”. At LabWare’s North America Customer Education Conference (CEC), Sera Prognostics, Inc., a client dedicated to improving maternal healthcare and fetal medicine, shared how LabWare LIMS supports their innovative diagnostic process, which helps to predict pre-term complications.
Sera Prognostics developed their flagship PreTRM® test in their CAP and CLIA-certified lab, which detects the greater risk of premature delivery. This test has been shown to reduce the length of stay in hospitals, thereby simultaneously improving health economics. 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…and children born prematurely can require long-term or lifetime care, with significant additional cost”. Furthermore, according to an article released by LabCorp, “up to 50% of women who deliver prematurely do not have any identified risk factors for preterm birth”.
Sera focuses on proteomics, or the analysis of proteins, in this case, circulating protein biomarkers in women around 18-20 weeks of gestation, with the goal of reducing preterm birth rates. The company developed and validated PreTRM® as a mass spectrometry test to help predict spontaneous preterm delivery in asymptomatic pregnant women.
Previously, the LIMS Sera was operating was not robust enough and was difficult to troubleshoot or enhance. By employing the LabWare Clinical Health Solution, the client and LabWare worked together in a multi-phased approach to implement a more intuitive and efficient workflow.
The complexity of the PreTRM® testing process presented challenges in analytical specimen batch building and user workflows. The mass spec test is performed after a multi-step preparation process. Scientists review the mass spec data, and then LabWare applies the lab’s specific algorithm to generate a test report with a score that helps doctors assess preterm birth risk.
Initially, three separate batches existed without linkage, each containing two data sets. By collaborating with LabWare’s services team, in a follow-up phase, Sera implemented a process to automatically generate subsequent batches after creating the initial batch. This streamlined the process, reducing effort for test scripts and documentation by half, while also shortening deployment to LabWare LIMS Go-Live.
Now Sera can build analytical batches of differing sample types in the correct order and track multiple instruments, equipment, reagents, lot numbers, and time points for every batch. Imperative to each user is the navigability and intuitiveness of the interface, and easy access to the results. LabWare provides a batch summary report that effectively allows lab users to locate information associated with any batch, at any phase in the process, avoiding the need for involvement from the LIMS Administrators to respond to daily requests for assistance.
LabWare worked with this customer to drive clinical laboratory workflow automation, resulting in improved workflow efficiency, better organizational communication, and a more efficient deployment cycle.
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