Sera Prognostics announces the publication of the clinical validation of the PreTRM® threshold for clinical action



SALT LAKE CITY, November 3, 2021 / PRNewswire / – Serum prognosis Inc., The Pregnancy Company® (NASDAQ: SERA), focused on improving maternal and newborn health by providing innovative information on pregnancy biomarkers to physicians and patients, today announced the publication of a rigorous point validation. clinical decision at a risk of spontaneous premature birth (sPTB) of 15%, as determined by the Company’s PreTRM® test.

In the Proteomic Assessment of Preterm Risk (PAPR) study, patients at 15% or greater risk, or twice the risk of the intended use population, were shown to have a significantly higher risk of sPTB. This risk threshold was independently validated in the Multicenter Assessment of Spontaneous Preterm Birth Predictor (TREETOP), a completely separate patient cohort, demonstrating that risk stratification at or above this PreTRM® threshold significantly separates high-risk pregnancies from low-risk pregnancies. The study was conducted according to the National Academy of Medicine (NAM) guidelines for test development.

In addition, at or above the threshold, severe neonatal morbidity and / or mortality was significantly elevated. Identifying asymptomatic pregnancies at higher risk for sPTB and adverse maternal and newborn outcomes is critical to reducing the huge impact of preterm birth on health outcomes, as it enables proactive interventions in patients who are really at higher risk. These new findings have been published in the peer-reviewed journal Journal of Clinical Medicine in an article entitled “Clinical validation of a proteomic biomarker threshold for an increased risk of preterm spontaneous birth and associated clinical results: a replication study”.

“The publication of these data adds to the growing body of evidence supporting the clinical validity and utility of Sera’s PreTRM® test to identify women at risk for sPTB and associated adverse neonatal outcomes. Sera’s prospective intervention studies and health economic models are all based on a PreTRM risk threshold of approximately twice the mean risk when testing is applied to populations, ”said Gregory C. Critchfield, MD, MS, President and CEO of Sera Prognostics. “We look forward to discussing the implications of this data as we engage with physicians, employers and payers in our efforts to improve pregnancy outcomes and reduce healthcare costs through expanded access to PreTRM. .® test.”

Study analysis involved the use of Sera’s two large prospective clinical studies (PAPR and TREETOP), which recruited more than 10,000 subjects from 20 sites across the United States.

The main conclusions of the analysis are as follows for subjects with a PreTRM® score equal to or greater than the validated threshold:

  • Significantly increased risk of sPTB
  • Significantly increased risk of preterm birth occurring before 37, 35 and 32 weeks
  • Significant increase in length of stay in neonatal hospital
  • Significant increase in mother’s length of stay in hospital
  • Significant increase in severe neonatal outcomes

This validated cut-off allows physicians to take action and implement a proactive testing and treatment strategy to identify women at risk for BPs and offer evidence-based interventions to reduce the risk, thereby improving outcomes. pregnancy while reducing the economic burden on payers, employers, and health systems.

About Sera Prognostics, Inc.

Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera’s mission is to provide physicians with essential and early information about pregnancy, enabling them to improve the health of their patients, which translates into reduced health care delivery costs. Sera has a strong portfolio of innovative diagnostic tests focused on early prediction of the risk of preterm birth and other pregnancy complications. Precision medicine from Sera PreTRM® The test reports the individualized risk of spontaneous preterm delivery during pregnancy to a doctor, allowing for earlier proactive interventions in women at higher risk. Sera Prognostics is located at Salt Lake City, Utah.

About premature birth

Premature birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. The March of Dimes 2020 report card shows that of the approximately 3.8 million babies born each year in United States, more than one in ten is born prematurely. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory disease, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the life of the children concerned. The annual health care costs to manage the short- and long-term complications of prematurity in United States were estimated at around $ 25 billion for 2016.

About PreTRM® Test

The pre-MRT® is the only commercially available widely clinically validated blood biomarker test that provides early, accurate and individualized prediction of the risk of spontaneous preterm delivery in asymptomatic single pregnancies. The pre-MRT® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The pre-MRT® The test allows doctors to identify, in the 19th or 20th week of pregnancy, which women are at increased risk of preterm delivery, allowing for more informed and personalized clinical decisions based on each woman’s individual risk. . The pre-MRT® the test is ordered by a healthcare professional.

Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc in the United States and / or other countries.

Safe Harbor Declaration

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the discussion of such data with physicians, employers and payers; and corporate strategic guidelines under the title “About Sera Prognostics, Inc.” These “forward-looking statements” are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those stated or under- understood by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation and the potential need to raise more capital; income from the PreTRM test representing almost all of the Company’s income to date; the need for broad scientific and commercial acceptance of the PreTRM test; a concentrated number of hardware customers; our ability to introduce new products; potential competition; our exclusive biobank; critical suppliers; the ongoing COVID-19 pandemic and its impact on our operations, as well as the activities or operations of third parties with whom we do business; estimates of the total addressable market opportunity and market growth forecasts; potential coverage and reimbursement by a third party payment; the new reimbursement methodologies applicable to the PreTRM test, including the new CPT codes and the payment rates for these codes; changes in FDA regulations on lab-developed tests; intellectual property rights protecting our tests and our market position; and other factors discussed under “Risk Factors” contained in our final prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to these risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K or Current Reports on Form 8-K. All information in this press release is as of the date of publication, and the Company does not undertake to update this information, except as required by law.


Investor contact
Peter DeNardo, CapComm Partners
[email protected]
+1 (415) 389-6400

Media contact
Erich Sandoval, Lazar FINN
[email protected]
+1 (917) 497-2867

SOURCE Will be Prognostics, Inc.

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