Progenity Announces Successful Completion of Clinical Validation Study and Achievement of the Primary Endpoint for its Preeclampsia Rule-Out Test
SAN DIEGO, July 29, 2021 (GLOBE NEWSWIRE) -- 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, whichsupports 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™ Test
Forward Looking Statements
Keynote: State of the Cannabis Business Vertical
Asset Management â€“ Keeping Remote Devices Connected
Lone Worker Safety Solutions