Sera Prognostics Announces Analytical Validation Study
SALT LAKE CITY, June 26, 2017– Sera Prognostics, Inc., a women’s healthcare company, announced today that its recent analytical study, “Analytical Validation of Protein Biomarkers for Risk of Spontaneous Preterm Birth” has been published in the June issue of Clinical Mass Spectrometry. The study details a rigorous analytical validation of Sera’s liquid chromatography/mass spectrometry (LC/MS) platform for sensitive later-generation Agilent mass spectrometers. This work confirms Sera’s ability, across instrument generations, to perform accurate analytical measurements required to provide individualized determination of a woman’s risk of spontaneous early delivery through Sera’s groundbreaking PreTRM® test. The PreTRM® test is the first and only broadly clinically-validated blood test that provides an early and individualized prediction of preterm birth risk.
“The Clinical Mass Spectrometry analytical validation paper highlights the strong science and rigorous analytical process discipline that underpins Sera’s commercial PreTRM® testing. It further demonstrates the robustness of our LC/MS technology platform,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “Sera’s high performing analytical platform accurately measures important biomarkers that are highly predictive of spontaneous premature delivery, a prerequisite for addressing the enormous global challenges of prematurity.”
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. 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.
About the PreTRM® Test
The PreTRM® test is the first and only broadly 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 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.
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, a women’s health company, develops innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera has launched its PreTRM® test, the first and only broadly clinically-validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s technology addresses both the health and economic challenges of PTB. The Company’s strong management team has significant clinical development and women’s healthcare diagnostic experience. Sera is backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, the Bill & Melinda Gates Foundation, and LabCorp, who recently entered into an agreement with the Company to become the exclusive U.S. distributor of the PreTRM test. Currently, Sera is working with the Gates Foundation to translate the Company’s discoveries into technologies well suited for low-income countries in its journey to improve maternal and infant health globally. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.
Andrew Sauter, CFO
Sera Prognostics, Inc.
Media Contact for Sera Prognostics:
Continuum Health Communications