Progenity Presents Key Verification Study Data for Preecludia™ Preeclampsia Rule-out Test at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting
SAN DIEGO, April 30, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced new data from its Preecludia preeclampsia rule-out test verification study are being presented today at the 2021 ACOG Annual Meeting, with the test demonstrating sensitivity of 87.8% and a negative predictive value (NPV) of 97.0%. The company recently announced it is in the clinical validation testing phase of Preecludia, with a targeted launch expected in the second half of 2021.
Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 women presenting each year with signs and symptoms of possible preeclampsia. It is characterized as a hypertensive disorder, but it is often difficult to clinically differentiate it from other hypertensive conditions in pregnancy, making diagnosis and management difficult. 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.
In the verification study being presented at ACOG today, blinded, naïve samples from twenty-four U.S. sites were tested to determine the performance of Preecludia to assess the risk of preeclampsia within fourteen days of sample collection. The samples were representative of a diverse U.S. population. Preecludia test performance, based on 303 subjects, showed 87.8% sensitivity and 97.0% NPV. These data point to the value of the test in assisting physicians to rule out patients at risk for preterm preeclampsia. By so doing, the test may provide reassurance to physicians and patients, and assist physicians in making better informed management and treatment decisions, potentially reducing overuse of interventions and resultant complications.
“These data and prior studies are strong indicators of the future performance of the Preecludia test, and we are honored to present them at ACOG,” said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. “They are also particularly timely as we mark Preeclampsia Awareness Month in May. We have initiated analysis of our PRO-104 validation study patient samples and plan to share the performance data, established with samples from over 1,300 patients, in the June/July timeframe. We expect to bring our Preecludia test to market soon thereafter, to finally provide doctors and expectant women with a unique, modern solution for improving preeclampsia risk assessment.”
Preecludia 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 run from a simple blood draw and is designed to address the unmet need for tools to aid in the assessment and management of preeclampsia. The U.S. market opportnity is for Preecludia is estimated at up to $3 billion, with additional global market opportunities.
The data presented at ACOG are part of the virtual meeting’s interactive ePosters. Details of the presentation are as follows:
Title – Performance of a novel multi-biomarker rule out preeclampsia test: a prospective verification study
The poster presentation will also be made available on the Progenity website following the conference.
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