SMFM Conference and Publications Highlight the Challenges and Complexities of Diagnosing and Managing Preeclampsia
Progenity celebrates the Society for Maternal-Fetal Medicine's focus on preeclampsia diagnostics, highlighting the challenges in this area. The Preecludia™ test, set to launch in the second half of 2021, will be the first U.S. test specifically designed to rule out preeclampsia, based on biomarkers from multiple pathophysiological pathways. Preeclampsia, a significant cause of maternal mortality, affects over 700,000 women annually. The company aims to address this unmet need through its innovative biomarker assay.
- Preecludia™ test could be the first of its kind in the U.S. for preeclampsia risk assessment.
- Strong clinical and analytical verification data reported in November.
- Planned validation phase and launch in the second half of 2021.
- Preeclampsia is the second most common cause of maternal mortality, indicating a significant unmet medical need.
- Challenges in diagnosing preeclampsia remain due to overlaps with other conditions.
Progenity applauds focus on preeclampsia biomarkers as it prepares for the launch of the Preecludia™ test
SAN DIEGO, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, applauds the continuing focus of the Society for Maternal-Fetal Medicine (SMFM) on the challenges of diagnosing and managing preeclampsia. Preeclampsia was the focus of this year’s President’s Workshop at the SMFM 2021 Virtual Annual Meeting, co-hosted by the Preeclampsia Foundation.
The SMFM President’s Workshop highlighted the latest research in diagnosing and managing patients with preeclampsia. The session titled Gray Zone Preeclampsia confirmed and highlighted the challenges of diagnosing preeclampsia due to non-specific symptoms, overlap with other hypertensive disorders of pregnancy, and limited diagnostic tools. Other sessions focused on the promise of biomarkers and multi-omics as part of the ongoing research on preeclampsia.
The SMFM publication, American Journal of Obstetrics & Gynecology (AJOG) also recently published an article by Redman, et.al., highlighting the complexity of preeclampsia, which is a syndrome involving multiple pathophysiological pathways. The authors stress there is an urgent need to understand the complex, multi-factorial pathways of preeclampsia at the cellular level, including biomarkers, to better characterize and manage patients.
The Preeclampsia Foundation, co-hosts of the SMFM President’s Workshop, issued a national call to action in October for the development of biomarker tests specific to the pathophysiology of preeclampsia due to this unmet need.
“We have heard very clearly from the SMFM, the Preeclampsia Foundation, and healthcare providers across the country, that new technology to evaluate risk for preeclampsia is urgently needed. We believe that biomarker testing is important, because complex syndromes require sophisticated solutions,” said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity. “We are responding to these needs by preparing for launch of the Preecludia™ test, our novel preeclampsia biomarker assay. We look forward to announcing additional milestones throughout 2021 as we usher in a new era of risk assessment for preeclampsia.”
The Preecludia rule-out test for preeclampsia could be the first of its kind in the United States to help healthcare providers evaluate patients with signs and symptoms of possible preeclampsia. This novel, multi-analyte, protein biomarker assay is designed to look at markers across multiple pathophysiological pathways to assess risk for preeclampsia. The laboratory developed test requires a simple blood draw, and is designed to aid in the triage and management of preeclampsia. Last November, the company released strong clinical and analytical verification data, and it plans to enter the validation phase later in Q1, followed by a targeted launch in the second half of 2021.
Preeclampsia is the second most common cause of maternal mortality, and more than 700,000 women present each year with signs and symptoms of possible preeclampsia. Preeclampsia is characterized as a hypertensive disorder, but it is difficult to differentiate from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Preeclampsia can result in impaired organ function, seizures, stroke, and death, and often requires pre-term delivery of the baby. This can result not only in poor health outcomes, but also significant healthcare costs.
For further information about preeclampsia and the Preecludia test, access the slides presented at the company’s Preeclampsia R&D Day at: progenity.com/presentations.
For more information about Progenity’s products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.
About Progenity
Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company 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 additional information about Progenity, please visit the company’s website at www.progenity.com.
Forward Looking Statements
This 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, including statements the development progress of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the performance of the rule-out test in an upcoming validation study, the completion of our upcoming validation study, and our efforts and intent to commercialize the Preecludia test and address an unmet medical need. 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,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the size and growth potential of the markets for our products, and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the outcome of pending and future investigations and legal proceedings, the loss or retirement of key scientific or management personnel, our ability to develop and maintain our corporate infrastructure, including maintaining effective internal controls, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim 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 Uhl
Managing Director, Westwicke ICR
ir@progenity.com
(619) 228-5886
Media Contact:
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CG Life
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(619) 743-6294
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