Sera Prognostics Announces Publication of
Positive AVERT PRETERM TRIAL Results in the International
Peer-Reviewed Journal, Diagnostics
SALT
LAKE CITY, July 9, 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 the publication in Diagnostics, an
international, peer-reviewed, open access journal on medical
diagnosis, of the top-line results from the AVERT PRETERM
TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to
Historical Controls), conducted at ChristianaCare in Wilmington, Delaware.
PreTRM® test-and-treat strategy
demonstrates statistically and clinically significant improvement
in neonatal health outcomes and hospital length-of-stay
Previously, Sera reported that both co-primary
outcomes—reduction of severe neonatal morbidity or neonatal death;
and decreased length of neonatal hospital stay—met their endpoints,
and the improvements in outcome with a PreTRM®
test-and-treat approach were statistically significant. Notably,
results from the AVERT PRETERM TRIAL indicated:
- An 18% reduction in severe neonatal morbidity and
mortality,
- A 7-day reduction in mean neonatal hospital length of
stay,
- Increased average gestational age at birth before 32 weeks of
2.48 weeks,
- And a 28-day reduction in neonatal length of hospital stay for
babies born before 32 weeks' gestation, reducing time spent in the
hospital for those at risk of earliest delivery.
The manuscript also reports that neonatal morbidity and
mortality and hospital and NICU length of stay were significantly
reduced in the entire intent-to-treat population. The test and
treat strategy was associated with a decreased odds of preterm
birth and spontaneous preterm birth at various gestational ages at
birth and an average NICU length of stay savings of 0.6 days per
pregnancy across all pregnancies tested.
"These results suggest that biomarker spontaneous preterm birth
risk stratification and preventive interventions can ameliorate
preterm birth complications in singleton, often nulliparous,
pregnancies historically deemed low risk," said Dr. Matthew Hoffman, Marie
E. Pinizzotto, M.D., Endowed Chair, Department of Obstetrics
& Gynecology, Director, Center for Women & Children's
Health Research, ChristianaCare, the study's principal
investigator.
"The AVERT PRETERM TRIAL results demonstrate for the first time
that the health of babies can be improved in asymptomatic pregnant
mothers without typical risk factors by the combination of
biomarkers for spontaneous preterm birth risk and targeted
interventions," said Zhenya Lindgardt, President and CEO of Sera
Prognostics. "We are delighted to have published these clinically
significant results in Diagnostics. We are now actively
engaged in analyzing our final PRIME study results to continue to
enrich an already broad portfolio of evidence for our
PreTRM® test-and-treat strategy in improving maternal
and neonatal care while reducing healthcare costs."
Update on Sera Prognostics PRIME Study
As Sera announced in December
2023, the Data Safety and Monitoring Board (DSMB) overseeing
the Company's 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.
Sera Prognostics noted in May 2024
that deliveries of PRIME study participants, the remaining 2,200
who were enrolled before enrollment stopped per DSMB
recommendation, were complete and all mothers and babies within the
study have left the hospital and data gathering for the final PRIME
results has begun.
About the AVERT PRETERM TRIAL
The AVERT PRETERM TRIAL evaluated the health benefit afforded to
babies when pregnancies are screened with the PreTRM®
Test and physicians intervened based on those results. An active
arm of approximately 1,463 expectant mothers in the ChristianaCare
in Delaware was tested in
mid-pregnancy to stratify for increased risk of spontaneous preterm
birth risk and those at higher risk were offered evidence-based
interventions, which included care management, more intensive
education, and medications. A historical control arm of
approximately 10,000 patients was drawn from the immediate 2-year
period before the trial enrollment began. Important neonatal
outcomes that included total neonatal length of hospital stay and
composite neonatal morbidity/mortality were analyzed in the
active and historical control arms.
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
and digital tools 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 healthcare 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, 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 the final PRIME study
results enriching an already broad portfolio of evidence for our
PreTRM® test-and-treat strategy; additional milestones
in advancing the Company's role to improve maternal and neonatal
healthcare outcomes; 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.