SALT
LAKE CITY, Dec. 6, 2023 /PRNewswire/ -- Sera
Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA),
focused on improving maternal and neonatal health by providing
innovative pregnancy biomarker information to doctors and patients,
today announced that the Data Safety Monitoring Board (DSMB)
overseeing its pivotal Prematurity Risk Assessment
Combined with Clinical Interventions for Improved Neonatal
OutcoMEs (PRIME) study recommended stopping enrollment due
to efficacy, reporting that either of the co-primary endpoints met
the stopping criteria for statistical significance at the
pre-planned interim analysis. The Company has adopted the DSMB's
recommendation and will stop PRIME study enrollment to focus on
analyzing and reporting the available data.
"We are excited by this report of efficacy from the DSMB," said
Zhenya Lindgardt, President and CEO of Sera Prognostics. "It is
unexpected for trials to stop early for efficacy since most
statistical power is typically reserved for the final analysis,
which makes this event that much more encouraging. We look forward
to sharing top-line results once we have had a chance to analyze
the interim look data. We believe this will add to the PREVENT and
AVERT studies in the growing, consistent body of evidence for our
PreTRM® test that advances our mission to save lives and
improve health for mothers and babies across the globe."
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 early,
pivotal pregnancy information to improve the health of mothers and
newborns, resulting in reductions in the costs of healthcare
delivery. Sera has a robust pipeline of innovative diagnostic tests
focused on the early prediction of preterm birth risk and other
complications of pregnancy. Sera's precision medicine
PreTRM® Test reports to a physician the individualized
risk of spontaneous premature delivery in a pregnancy, enabling
earlier proactive interventions in women with higher risk. Sera
Prognostics is headquartered in Salt Lake
City, Utah.
About Preterm Birth
Preterm birth is defined as any birth before 37 weeks' gestation
and is the leading cause of illness and death in newborns. The 2022
March of Dimes Report Card shows that, for the last four
consecutive years, more than one in ten infants is born
prematurely. 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 health care costs to manage short- and
long-term complications of prematurity in the United
States were estimated to be approximately $25
billion for 2016.
About the PreTRM® Test
The PreTRM® Test is the only broadly validated,
commercially available blood-based biomarker test that provides an
early, accurate and individualized 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 permits physicians to identify, during the weeks 18 through 20
of pregnancy, which women are at increased risk for preterm birth
and its complications, enabling more informed, personalized
clinical decisions based on each woman's individual risk. The
PreTRM® Test is ordered by a medical 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 Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to stopping PRIME study
enrollment; analyzing and reporting the available data; sharing
top-line results from the interim look data; the interim look
adding to the PREVENT and AVERT studies in the growing, consistent
body of evidence for the PreTRM® test; advancing the
Company's mission to save lives and improve health for mothers and
babies across the globe; and the company's strategic directives
under the caption "About Sera Prognostics, Inc." These
"forward-looking statements" are based on management's current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied 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; revenues from the PreTRM Test
representing substantially all Company revenues to date; the need
for broad scientific and market acceptance of the PreTRM Test; a
concentrated number of material customers; our ability to introduce
new products; potential competition; our proprietary biobank;
critical suppliers; the COVID-19 pandemic and its potential
lingering impact on our operations, as well as the business or
operations of third parties with whom we conduct business;
estimates of total addressable market opportunity and forecasts of
market growth; potential third-party payer coverage and
reimbursement; new reimbursement methodologies applicable to the
PreTRM Test, including new CPT codes and payment rates for those
codes; changes in FDA regulation of laboratory-developed tests; the
intellectual property rights protecting our tests and market
position; and other factors discussed under the heading "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 those
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 the
release, and the Company undertakes no duty to update this
information unless required by law.
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SOURCE Sera Prognostics, Inc.