Progenity (PROG) Announces Patent Granted by USPTO for its Preeclampsia Rule-Out Test

Progenity, Inc. (Nasdaq: PROG), an innovative biotechnology company, announced today 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.

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.

“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. Consistent with the company’s recent strategic transformation, Progenity is evaluating commercialization opportunities for launch of the LDT within the United States, and IVD embodiments to access the global opportunity for the Preecludia™ test. The company previously announced successful completion of the clinical validation study and achievement of the primary study endpoint, and is pursuing publication of the study results in a peer-reviewed medical journal.

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.

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