Highlights the Proper Experimental Design and Reporting Required for Accurate Biomarker Prediction Performance
Sera Approach Exemplifies Best Practice for Building Population Screening Tests
SALT LAKE CITY–(BUSINESS WIRE)–Sera Prognostics, Inc., (“Sera” or the “Company”), the leading health diagnostics company dedicated to improving the lives of women and babies through individualized prenatal care, today announced that a key scientific publication, “Effects of Selective Exclusion of Patients on Preterm Birth Test Performance,” authenticates Sera as the leading authority in using biomarkers to assess preterm birth risk. Sera’s comprehensive, best practice approach for building predictive screening tests has resulted in PreTRM®: the only clinically-validated, commercially available blood test to accurately assess a woman’s individualized risk of delivering her infant prematurely.
In their publication, Jay J. Boniface, PhD, Julja Burchard, M.S., and George R. Saade, M.D. explain that when assessing any predictive test’s performance, all patients for whom the test will be applicable clinically (also known as the intended-use population), must be evaluated in order to determine valid predictions that providers can use to improve care delivery. To validate the actual performance of a premature birth prediction, the intended-use population must include patients delivering across the entire spectrum of gestational ages.
In contrast to this best practice, many examples from biomarker research show early discoveries characterized as high performing predictions, when the performance is falsely elevated through selective omission of subsets of patients from the data analysis. Such predictions are actually mis-calibrated—over- or under-calling the actual risks of premature delivery. Mis-calibration could result in suboptimal treatment decisions for the patients tested, and have potentially serious regulatory consequences.
Gregory C. Critchfield, M.D., M.S., Chairman and Chief Executive Officer of Sera, said, “This publication provides unparalleled evidence of the strength of Sera’s science and position as the industry leader in properly calibrated biomarker prediction. At Sera, we take our mission of improving the lives of women and babies very seriously and are proud to call our PreTRM® test the only clinically available, valid biomarker test providing the information doctors and patients require for earlier proactive decision-making and intervention.”
“Effects of Selective Exclusion of Patients on Preterm Birth Test Performance,” was recently released online ahead of print in the journal Obstetrics & Gynecology (December 2019; volume 134, issue 6).
About Preterm Birth
According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity. Of nearly 4 million babies born annually in the U.S., approximately one in ten is born prematurely.1 Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual US health care costs to manage complications of prematurity were estimated at $31.5B for 2015.2
About the PreTRM® Test
The PreTRM® test is the only clinically-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 is ordered by a medical professional. For more information about the PreTRM® test, please visit www.PreTRM.com and the PreTRM® test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.
About Sera Prognostics, Inc.
Sera Prognostics is the leading health diagnostics company dedicated to improving the lives of women and babies through individualized prenatal care. Sera delivers pivotal information to physicians to improve health and the economics of healthcare delivery for pregnant women. Sera is developing innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s PreTRM® test objectively reports to a physician the risk of a woman’s premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve the health of her baby. Sera’s strong management team has significant clinical development and women’s healthcare diagnostic experience. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.