Progenity Presents Key Data from the Verification Study for the Preecludia ™ Preeclampsia Exclusion Test at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting
Data show high sensitivity and negative predictive value (NPV)
SAN DIEGO, April 30, 2021 (GLOBE NEWSWIRE) – Offspring, Inc. (Nasdaq: PROG), a biotechnology company with a proven track record in the development and commercialization of molecular test products, today announced that new data from its exclusion test verification study of preeclampsia Preecludia are presented today at Reunion 2021, with the test demonstrating a sensitivity of 87.8% and a negative predictive value (NPV) of 97.0%. The company recently announced that it is in the clinical validation testing phase of Preecludia, with a targeted launch slated for the second half of 2021.
Preeclampsia is the second most common cause of maternal death, with more than 700,000 women showing signs and symptoms of possible preeclampsia each year. It is characterized as a hypertensive disorder, but it is often difficult to differentiate clinically from other hypertensive conditions during pregnancy, making diagnosis and management difficult. Ultimately, if left undiagnosed and improperly managed, preeclampsia can lead to impaired organ function, seizures, stroke, and death in the mother, and may require premature delivery. Preeclampsia can lead to both poor health outcomes and significant costs.
In the verification study presented at ACOG today, blinded naive samples from twenty-four US sites were tested to determine the performance of Preecludia to assess the risk of preeclampsia within fourteen days of treatment. sample collection. The samples were representative of a diverse American population. The performance of the Preecludia test, based on 303 subjects, showed a sensitivity of 87.8% and a NPV of 97.0%. These data underscore the test’s value in helping physicians rule out patients at risk for premature preeclampsia. In doing so, the test can reassure physicians and patients, and help physicians make more informed management and treatment decisions, potentially reducing overuse of procedures and resulting complications.
“These data and past studies are strong indicators of the future performance of the Preecludia test, and we are honored to present them to 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 patient samples from our PRO-104 validation study and plan to share performance data, established with samples from over 1,300 patients, in the June / July period. We plan to market our Preecludia test shortly thereafter, to finally provide physicians and pregnant women with a unique and modern solution to improve risk assessment for preeclampsia. “
Preecludia has the potential to be the first test of its kind in the United States to help healthcare providers assess patients who have signs and symptoms of possible preeclampsia. This laboratory-developed test (LDT) is a new multi-analyte protein biomarker assay designed to examine markers of several pathophysiological pathways in pre-eclampsia to assess risk. It is done from a simple blood test and is designed to address the unmet need for tools to aid in the assessment and management of preeclampsia. The US market opportunity for Preecludia is estimated at $ 3 billion, with additional opportunities in the global market.
The data presented at ACOG is part of the interactive ePosters of the virtual meeting. The details of the presentation are as follows:
Title – Performing a new multi-biomarker preeclampsia exclusion test: a prospective verification study
Authors – Matthew Cooper, PhD, DABT, MBA; Amin Mazloom, PhD; Chelsea Obrochta, PhD (c); Ronald Wapner, MD; Todd Rosen, MD; Allan Bombard, MD
Poster number 999251
The poster presentation will also be available on the Offspring website following the conference.
Progenity, Inc. is a biotechnology company with a proven track record in the development and commercialization of molecular assay products, as well as innovation in precision medicine. Progenity offers in vitro molecular tests designed to improve lives by providing actionable information that helps patients and physicians make medical decisions at key stages of life. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics and metabolomics to its molecular test products and to the development of a suite of experimental ingestible devices designed to provide solutions for diagnostic sampling and testing. administration of specific medications. Progenity’s vision is to transform healthcare to become more precise and personal by improving disease diagnoses and improving patient outcomes through spot treatment with targeted therapies. For more information on Progenity, please visit the company’s website at www.progenity.com.
This press release contains “forward-looking statements”, which are subject to significant risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical fact included in this press release, including statements regarding the progress of development of our preeclampsia exclusion test, its future use by suppliers to rule out preeclampsia, the performance of the exclusion testing in an upcoming validation study, the completion of our next validation study, and our efforts and intention to commercialize the Preecludia test and address an unmet medical need, are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “may”, “could”, “will”, “objective”, “intend”, “should”, “could”, “may”, “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 actual results of the company to differ materially from the forward-looking statements expressed or implied in this press release, including our ability to develop and market our test 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 the coverage and reimbursement rate of our products, regulatory developments in the United States and in foreign countries, our ability to obtain and maintain regulatory approval or authorization of our products on schedule or not at all, our ability to improve and improve our products, the fact that the data presented relates to the verification stage and may not predict the results future, including those of the validation stage, development, regulatory approval, efficacy and commercialization of competing products, loss or retirement of key scientific or management personnel , 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, the ongoing COVID-19 pandemic and associated impact on our business, and the 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 that we file with the SEC. We claim the safe harbor protection contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or modify any statements whether as a result of new information, future events or otherwise, except as required by law.
Managing Director, Westwicke ICR