May is Preeclampsia Awareness Month, and a recent survey is underscoring a stark need for more education around the second-most common cause of maternal mortality in the United States. The survey of nearly 800 women, including expectant mothers, new mothers within the last year, and those who are considering pregnancy, was conducted by Progenity, Inc. (Nasdaq: PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products in women’s health. The results showed less than half of respondents know that high blood pressure, the main sign of preeclampsia, is a key indicator of the condition. In contrast, more than 50 percent of respondents know the “fruit size” of a baby at 12 weeks, a popular milestone marker for moms-to-be. This survey points to the need for further patient awareness and education around the symptoms of preeclampsia, a potentially dangerous complication of pregnancy.
Nearly 30% of pregnant women in the United States experience signs and symptoms of possible preeclampsia, a condition that can occur during pregnancy or up to six weeks after. The condition is often missed or misdiagnosed because the symptoms are common and non-specific, making it difficult for doctors to clinically distinguish between those most at risk and those at a reduced risk. If undiagnosed or poorly managed, the condition can result in impaired organ function, seizures, stroke, and even mortality in the infant or mother, and may require pre-term delivery. In fact, approximately 5-8% of all pregnancies are complicated by preeclampsia.
“Early recognition of preeclampsia can save lives,”
said Eleni Tsigas, CEO of the Preeclampsia Foundation. “This survey shows us how much work still needs to be done to educate pregnant women about the signs and symptoms of this devastating condition. All women need to know their risk for preeclampsia because timely diagnosis and management is critical.”
It can be difficult to evaluate suspected preeclampsia because there are more than a dozen signs and symptoms that can differ from woman to woman. The two main signs—high blood pressure and protein in the urine—typically aren’t noticed without a visit to the doctor. Additionally, risk factors vary and include common features such as first pregnancy, obesity, diabetes, maternal age younger than 18 or older than 35, and family history of preeclampsia. Black women are also at higher risk, and new research points to an increase in preeclampsia and preterm birth in women diagnosed with COVID-19.
“I wish I would have known what preeclampsia is, what the symptoms are, and the impact that it could have on my son’s life and mine. Instead, I found out about preeclampsia through surviving it and delivering my son early at 28 weeks,” said preeclampsia survivor, Jasmine Mago. “Now I live to raise awareness, provide education, and support research in hope that mortality rates will decrease and that there will be more progress in treatment and diagnosis.”
Despite the increasing rates of preeclampsia, there have been no significant advancements in diagnostic assessment tools in the United States in decades. However, doctors may soon have a reliable way to rule out the risk of preeclampsia for up to 14 days, modernizing the way they evaluate patients. Developed by Progenity, a proprietary lab test—called Preecludia—could potentially be a tool to help providers differentiate patients with symptoms who are not at risk for preeclampsia from those who may be at increased risk. The test is designed to be run from a simple blood draw.
“There’s a clear unmet need for additional tools to help rule out possible preeclampsia in expectant mothers, and I know this first-hand after almost losing my wife to preeclampsia after a missed diagnosis”
said Matthew Cooper, Ph.D., Chief Scientific Officer, Progenity. “The Preecludia test would be the first of its kind in the United States and would help to fill a gap in the assessment and management of preeclampsia. We look forward to offering the test to physicians and patients to make a real difference in the lives of mothers and babies.”
For more information about preeclampsia and how to recognize its signs and symptoms, visit the Preeclampsia Foundation.
Progenity’s preeclampsia rule-out test, 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. Positive performance data from the Preecludia verification study were presented April 30th at the American College of Obstetricians and Gynecologists (ACOG) Annual Meeting. The test is now in the final clinical validation testing phase, with a targeted launch expected in the second half of 2021
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 more information on how Progenity is helping clinicians and patients prepare for life, please visit progenity.com.
About the Preeclampsia Foundation
The Preeclampsia Foundation is a U.S.-based 501(c)(3) not-for-profit organization established in 2000. Its purpose is to improve the outcomes of hypertensive disorders of pregnancy by educating, supporting and engaging the community, improving healthcare practices, and finding a cure. The Preeclampsia Foundation envisions a world where hypertensive disorders of pregnancy no longer threaten the lives of mothers and their babies. For more information, visit www.preeclampsia.org.
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 concerning the development progress of our preeclampsia rule-out test, and its future use by providers to rule out preeclampsia, are forward-looking statements. 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 acceptance and clinical utility 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, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 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. 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.