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Progenity Provides Key Update Regarding its Preecludia™ Test for PreeclampsiaSAN DIEGO, May 05, 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 another key update regarding its Preecludia preeclampsia rule-out test. The company reported that its systems and processes necessary for commercial launch, including information systems, laboratory equipment, SOP finalization, and laboratory personnel training, all demonstrated commercial readiness as part of a pre-validation test. Additionally, data from this new, independent, prospective, naïve cohort examined as part of the pre-validation process showed test performance in the intended use population that was consistent with the verification study results presented April 30th at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting. The company recently announced it is in the clinical validation testing phase for the Preecludia test, with a targeted commercial 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 from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Ultimately, 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. The new data, generated with the original locked algorithm from the verification study, came from a cohort of more than 300 blinded samples equally distributed across gestational ages collected during the PRO-104 protocol, and examined as part of the pre-validation process. Analysis of these samples from the intended use population showed test performance consistent with the Preecludia verification study, indicating further de-risking of the program. The pre-validation test performance showed sensitivity greater than 87% and a negative predictive value (NPV) greater than 97% at a prevalence of 11%, and a rule out window of up to 14 days from sample collection. A similar level of performance, if observed in the larger PRO-104 validation study, would provide clinicians, especially OB/GYNs, with a new tool for their assessment of women at risk for preeclampsia. Preecludia is expected to result in a materially superior approach to the existing standard of care which offers an NPV of 83%, at best. “We are very encouraged by the performance of the Preecludia test as evidenced in these data and prior studies. This portends well for the future performance of Preecludia in our validation study and for when we reach the commercial market,” said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. “We have completed analytical testing and are initiating data analysis of the full set of patient samples from our validation study with over 1,300 patients. We plan to share the performance data from this validation study within the June/July timeframe. With these data in hand, we plan to bgin a targeted launch of Preecludia in the second half of 2021 by leveraging our existing OBGYN/MFM channel.” Progenity’s Preecludia is a preeclampsia rule-out test, not a diagnostic predictive test for preeclampsia. It 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 US market opportunity for Preecludia is estimated at up to $3 billion, with additional global market opportunities. The ACOG poster presentation of the verification study results is available on the Progenity website. For more information about Progenity’s products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter. About Progenity Forward Looking Statements Investor Contact: Media Contact: |