Startup Supported by Cedars Sinai Awarded Federal Grant to Develop Home Based Preeclampsia Test

Cedars-Sinai Technology Ventures-led startup Gravidas Diagnostics Inc. has been awarded a $3 million federal grant from the Advanced Research Projects Agency for Health (ARPA-H)to develop a first-of-its-kind, affordable, home-based fingerstick test for early detection of preeclampsia, a serious pregnancy complication.

The Advanced Research Projects Agency for Health, part of the United States Department of Health and Human Services, is an investment agency that was created by the U.S. Congress in 2022. The goal: to invest in and support high-impact medical research that could potentially create sustainable and equitable health solutions for critical areas of need, such as women's and maternal-fetal health.

"This award is a significant milestone for Gravidas," said Nirdesh K. Gupta, PhD, chief executive officer of Gravidas and managing partner of the Cedars-Sinai Intellectual Property Company. "It will enable us to develop a rapid, accurate test that can be easily administered at home, reassuring patients and allowing clinicians to identify high-risk pregnancies and proactively provide lifesaving care before the onset of symptoms."

Preeclampsia is a serious pregnancy complication that is typically diagnosed after 20 weeks of pregnancy, with most cases occurring near the due date. The usual signs of preeclampsia are high blood pressure, excess protein in urine, and swelling. If left untreated, preeclampsia can lead to organ damage and, rarely, death. In the U.S., preeclampsia is estimated to occur in up to 7% of all pregnancies and is one of the leading causes of maternal death and severe morbidity, with Black women being 60% more likely to develop preeclampsia compared with white women.

"Pregnant women with risk factors and limited access to routine obstetric care will be the largest beneficiaries of this home-based test. This innovative solution has the potential to reduce racial disparities in adverse pregnancy outcomes, particularly among Black women," said Sarah J. Kilpatrick, MD, PhD, a nationally renowned expert in maternal-fetal medicine and chair of the Department of Obstetrics and Gynecology at Cedars-Sinai.

Currently, there are no home-based tests available that can accurately detect preeclampsia early in pregnancy. Gravidas' innovative, low-cost fingerstick test, which uses technology born out of groundbreaking research funded and pioneered by Anders Berg, MD, PhD, vice-chair of Clinical Pathology at Cedars-Sinai, and Ananth Karumanchi, MD, professor of Medicine and director of the Renovascular Research Center at Cedars-Sinai, aims to change that.

"Preeclampsia can only be treated by delivering the baby," said Karumanchi, whose laboratory pioneered the discovery of the protein being used in the home test. "A rapid, easy-to-use, home-administered test prescribed by a physician can help to rule out imminent risk or to detect preeclampsia early and start necessary interventions to manage hypertension and reduce pregnancy-related complications."

In 2022, prior to receiving this ARPA-H award, investigators at Cedars-Sinai published a multicenter studywith over 1,000 patients, utilizing a blood test to assess the ratio between two key proteins-known as serum soluble fms-like tyrosine kinase 1 to placental growth factor ratio (sFlt‐1/PlGF)-in the bloodstream that predicted worsening of preeclampsia in hospitalized patients. The study, led by Cedars-Sinai investigators, resulted in Food and Drug Administration approval for use of the hospital-based blood test in the U.S. The home-based fingerstick test for preeclampsia will measure sFIt-1 in the bloodstream using colorimetric assay.

Given the increasing numbers of preeclampsia cases nationwide, the decision to create a home-based test for pregnant individuals to use and screen for the condition was the natural next step.

"Gravidas is working to ensure the test is widely accessible, cost-effective, equitable and easy for patients to use in the comfort of their own homes and other settings outside of the hospital," said Berg, chief technology officer at Gravidas.

"The development of this home-based test for preeclampsia is a testament to Cedars-Sinai's commitment to harnessing promising technology to build affordable solutions to address major areas of clinically unmet need, especially women's reproductive health, and to help improve overall patient outcomes," said Jeffrey A. Golden, MD, director of the Burns and Allen Research Institute and executive vice dean for Research and Education at Cedars-Sinai.

Read more on the Cedars-Sinai Blog: Cedars-Sinai Introduces Dutch Health-Tech Startups to US Markets

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