Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology
company, announced today successful completion of the validation
study for its Preecludia™ rule-out test for preeclampsia and
achievement of the primary endpoint of the study protocol.
The PRO-104 clinical validation study was a prospective,
multi-center, observational study with over 1,300 enrolled
subjects. Test specimens were collected from pregnant patients aged
18 to 45 years and 28 0/7 to 36 6/7 weeks’ gestational age.
Analysis was blinded. Patients in the study cohort presented with
potential signs and symptoms of preeclampsia at 20 labor and
delivery triage sites across all major regions of the United
States. Patient demographics were consistent with the at-risk U.S.
population.
“We are proud to have achieved the primary endpoint of the
PRO-104 study protocol, demonstrating that the Preecludia test can
significantly distinguish between the presence and absence of
preeclampsia, with the initial unblinding and analysis performed by
an independent third party,” said Matthew Cooper, PhD, Chief
Scientific Officer, Progenity. “The test’s high negative predictive
value, which achieved the targeted range determined from our market
research and clinician feedback, validates its utility in ruling
out preeclampsia, and positions the laboratory-developed test for
launch in the United States. We intend to soon publish our results
in a peer-reviewed medical journal. Because of embargo
considerations, we are limited in what we can share today.”
Preeclampsia is the second most common cause of maternal
mortality, with more than 700,000 pregnant women presenting with
signs and symptoms of possible preeclampsia each year. Ultimately,
if left undiagnosed and improperly managed, preeclampsia can result
in impaired organ function, seizures, stroke, and death in the
mother, and may require pre-term delivery of the baby. Preeclampsia
can result in both poor health outcomes and significant costs.
Preeclampsia is often missed or misdiagnosed because the symptoms
are common – appearing in up to 30% of pregnant women in the United
States – and can easily be attributed to other causes.
“Despite increasing rates of preeclampsia, there have been no
significant advancements in diagnostic assessment tools in the
United States in decades,” stated Martin Chavez, MD, FACOG,
Maternal-Fetal Medicine Specialist. “The Preecludia test will be an
invaluable tool to support physicians in the differential diagnosis
of patients with signs and symptoms of preeclampsia,” continued Dr.
Chavez, who has an active practice in high-risk obstetrics as part
of a leading NYC academic medical center.
The Preecludia test is expected to target an addressable
market of up to $3 billion in the United States. In addition to the
laboratory-developed test (LDT) immunodiagnostic under development,
this test has potential as an in vitro diagnostic (IVD) and
point-of-care solution globally. Consistent with the company’s
recent strategic transformation, Progenity is evaluating
commercialization opportunities for launch of the LDT within the
United States, and IVD embodiments to access the global opportunity
for the Preecludia™ test.
“We are excited to announce the successful completion of the
validation study for the Preecludia test and achievement of the
primary endpoint, which supports our intended use in the target
patient population,” said Harry Stylli, PhD, CEO, chairman of the
board and co-founder of Progenity. “Successful completion of the
PRO-104 study is another significant step toward equipping
physicians with a valuable new tool that will transform the
clinical management of patients at risk of preeclampsia and support
a compelling health economic benefit for society.”
About the Preecludia™ TestThe Preecludia
rule-out test for preeclampsia has the potential to be the
first-of-its-kind test in the United States to help healthcare
providers evaluate patients who have signs and symptoms of possible
preeclampsia. This laboratory developed test (LDT) is a novel,
multi-analyte protein biomarker assay designed to examine markers
from multiple pathophysiological pathways of preeclampsia to assess
risk. It is designed to be run from a simple blood draw and is
intended to address the unmet need for tools to aid in the
assessment and management of preeclampsia. To learn more about
preeclampsia and the Preecludia test, the company’s virtual R&D
day webcast from November 2020 can be viewed here. Results from the
Preecludia test verification study were presented at the American
College of Obstetricians and Gynecologists (ACOG) 2021 Annual
Meeting, and the company previously shared topline results from
pre-validation testing.
About ProgenityProgenity, Inc. is a
biotechnology company innovating in the fields of women’s health,
gastrointestinal health and oral biotherapeutics. Progenity applies
a multi-omics approach, combining genomics, epigenomics,
proteomics, and metabolomics to its molecular testing products and
to the development of a suite of investigational ingestible devices
designed to provide precise diagnostic sampling and drug delivery
solutions. Progenity’s vision is to transform healthcare to become
more precise and personal by improving diagnoses of disease and
improving patient outcomes through localized treatment with
targeted therapies.
For more information visit www.progenity.com, or follow the
company on LinkedIn or Twitter.
Forward Looking StatementsThis press release
contains “forward-looking statements,” which statements are subject
to substantial risks and uncertainties and are based on estimates
and assumptions. All statements, other than statements of
historical facts, included in this press release are
forward-looking statements, including statements regarding the
efficacy and potential utility of the Preecludia test, the timing
for launch of the Preecludia test, the potential addressable market
for the Preecludia test; the potential for IVD embodiments of the
Preecludia test; and any potential future commercialization
opportunities. In some cases, you can identify forward-looking
statements by terms such as “may,” “might,” “will,” “objective,”
“intend,” “should,” “could,” “can,” “would,” “expect,” “believe,”
“design,” “estimate,” “predict,” “potential,” “develop,” “plan” or
the negative of these terms, and similar expressions, or statements
regarding intent, belief, or current expectations, are forward
looking statements. These statements involve known and unknown
risks, uncertainties and other factors that could cause Progenity’s
actual results to differ materially from the forward-looking
statements expressed or implied in this press release, including
Progenity’s ability to successfully develop and commercialize its
products under development, the uncertainties inherent in the
clinical drug development process, such as the regulatory approval
process, the timing of regulatory filings, and other matters,
including the ongoing COVID-19 pandemic, that could affect
sufficiency of existing cash, cash equivalents and short-term
investments to fund operations and the availability or commercial
potential of Progenity’s products, and those risks described in
“Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in Progenity’s
Annual Report on Form 10-K for the year ended December 31, 2020,
filed with the SEC on March 18, 2021, and other subsequent
documents we file with the SEC, including but not limited to
Progenity’s Quarterly Reports on Form 10-Q. Progenity claims the
protection of the Safe Harbor contained in the Private Securities
Litigation Reform Act of 1995 for forward-looking statements.
Progenity expressly disclaims any obligation to update or alter any
statements whether as a result of new information, future events or
otherwise, except as required by law.
Investor Contact:Robert UhlManaging Director,
Westwicke ICRir@progenity.com (619) 228-5886
Media Contact:Kate Blom-LoweryCG
Lifemedia@progenity.com (619) 743-6294
Biora Therapeutics (NASDAQ:PROG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Biora Therapeutics (NASDAQ:PROG)
Historical Stock Chart
From Apr 2023 to Apr 2024