Biotech company Progenity has announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,112,403 for assessment of preeclampsia using assays for free and dissociated placental growth factor to the company. The patent is directed to methods, compositions, and kits for detecting and measuring free and dissociated placental growth factor (PlGF) levels in biological samples. PlGF is well established as an important biomarker for the assessment of preeclampsia, and recent studies have revealed the importance of distinguishing between the free and bound forms when assessing the complex physiological pathways involved in preeclampsia.
Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 pregnant women presenting with signs and symptoms of possible preeclampsia each year. Ultimately, if 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. Preeclampsia is often missed or misdiagnosed because the symptoms are common – appearing in up to 30% of pregnant women in the United States – and can easily be attributed to other causes.
The Preecludia rule-out test for preeclampsia 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 designed to be run from a simple blood draw and is intended to address the unmet need for tools to aid in the assessment and management of preeclampsia.
“We are pleased the USPTO has granted this patent covering unique and novel methods for determining levels of free and dissociated PlGF, since detection and quantification of both biomarkers are critical for assessing preeclampsia. This discovery helped drive the excellent performance we observed in our clinical verification and validation studies,” said Matthew Cooper, PhD, chief scientific officer of Progenity. “Patent protection is important as we pursue partnership opportunities for commercialization of the Preecludia test for the benefit of physicians and their patients.”
The Preecludia test is expected to target an addressable market of up to $3 billion annually in the United States. In addition to the laboratory-developed test (LDT) immunodiagnostic under development, this test has potential as an in vitro diagnostic (IVD) and point-of-care solution globally.