Progenity Inc. (NASDAQ: PROG) has completed the validation for the Preecludia rule-out test study for preeclampsia and primary endpoint achievement for the study pool.
Progenity conducted a validation study on 1,300 people
The PRO-104 clinical validation trial enrolled around 1,300 people in a randomized, multi-center observational study. Pregnant women from 18 to 45 years old with a gestational age of 28 0/7 to 36 6/7 weeks provided test specimens. The research was conducted under the guise of anonymity. At 20 delivery and labor triage sites across the US, patients in the trial group presented with possible symptoms and signs of preeclampsia. Patient demographics matched those of the at-risk population in the United States.
Matthew Cooper, Progenity Chief Scientific Officer, said, “We are proud to have achieved the primary endpoint of the PRO-104 study protocol, demonstrating that the Preecludia test can significantly distinguish between the presence and absence of preeclampsia, with the initial unblinding and analysis performed by an independent third party. The test’s high negative predictive value, which achieved the targeted range determined from our market research and clinician feedback, validates its utility in ruling out preeclampsia, and positions the laboratory-developed test for launch in the United States. We intend to soon publish our results in a peer-reviewed medical journal. Because of embargo considerations, we are limited in what we can share today.”
Preeclampsia is the second leading maternal death cause.
Preeclampsia ranks second among the leading maternal death causes, with more than 700,000 pregnant women showing preeclampsia signs and symptoms each year. Unfortunately, preeclampsia can lead to compromised organ function, stroke, seizures, and death of the mother, as well as pre-term delivery if left undetected and poorly managed. Preeclampsia can harm one’s health as well as cost a lot of money. Because the symptoms are prevalent and can easily be attributed to other causes, preeclampsia is frequently ignored or misdiagnosed.
