SALT
LAKE CITY, Dec. 4, 2024 /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 results of the PRIME study were
accepted as a late-breaking abstract for oral podium presentation
at the Society for Maternal-Fetal Medicine 2025 Pregnancy
Meeting™ on January 31, 2025 at
10:15 a.m. MT. Dr. Brian Iriye – maternal-fetal medicine expert at
the High Risk Pregnancy Center in Las
Vegas, Nevada, and principal investigator for the PRIME
study – will present the results of the full PRIME study.
The study – Prematurity Risk Assessment Combined with Clinical
Interventions for Improved Neonatal OutcoMEs (PRIME) –
evaluated how pairing the PreTRM test, used to identify pregnant
women who are at higher risk of delivering preterm, with targeted
clinical interventions may affect neonatal outcomes. The Company
announced in December 2023 that it
had stopped enrollment for the PRIME study following notice from
the Data Safety Monitoring Board that the pre-planned interim
analysis achieved at least one of its primary endpoints at the
required level of statistical significance. Since then, the Company
has focused on data gathering and analysis for the complete cohort
enrolled before the December 2023
stoppage, ultimately submitting a late-breaking abstract last month
for SMFM's consideration.
"Sera is honored that data for its PreTRM® test will
be presented from the podium at SMFM," said Zhenya Lindgardt,
President & CEO of Sera Prognostics. "This is a prestigious
conference, and exactly the right platform from which to share
these results with the community."
The annual Pregnancy Meeting™ is the centerpiece of the Society
for Maternal-Fetal Medicine's work and widely considered the
world's leading conference on the subject of pregnancy, featuring
postgraduate courses and workshops, luncheon roundtables,
scientific forums, oral and poster presentations, industry
learning, exhibits, and more. The PRIME abstract, one of five
selected for presentation in late-breaking oral sessions, is
expected to be published by SMFM ahead of the meeting in
mid-January 2025.
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 2023
March of Dimes Report Card shows that, for the last five
consecutive years, more than one in ten infants is born prematurely
in the United States. 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 Dr. Brian Iriye presenting the results of the PRIME
study at the podium at the Society for Maternal-Fetal Medicine 2025
Pregnancy Meeting on January 31, 2025
at 10:15 a.m. MT; the SMFM Pregnancy
Meeting being exactly the right platform from which to share PRIME
results with the community; publication of the PRIME abstract by
SMFM ahead of the meeting in mid-January
2025; 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
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed
with the Securities and Exchange Commission, as well as any updates
to those risk factors filed from time to time in our periodic and
current reports filed with the Securities and Exchange Commission.
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.