Thermo Fisher's biomarker blood tests to spot preeclampsia risk are first to win FDA nod

A pair of newly FDA-cleared blood tests from Thermo Fisher Scientific could be a major boon in the early detection and treatment of preeclampsia, a pregnancy complication that can endanger both the mother and fetus—and one that’s risen in prevalence in the U.S. in recent years.

The immunoassays test for novel biomarkers, each measuring a placenta-related protein in the blood—placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1), respectively—with the results presented as a ratio of both biomarkers.

When used alongside other clinical assessments, the ratio is meant to help determine the risk that individuals who’ve been hospitalized for hypertensive disorders of pregnancy will progress to severe preeclampsia within the next two weeks.

The assays are designed to run on Thermo Fisher’s Brahms Kryptor Compact Plus clinical analyzer, which churns out results within half an hour.

The freshly bestowed FDA clearance is the first given to any blood-based biomarker test for assessing preeclampsia risk, according to a Friday announcement from Thermo Fisher.

Being able to stratify patients by their individual severity level could help hospitals better prioritize treatment for those most in need; the current standard of care relies on measures of blood pressure and proteins detected in a urine sample, among other factors, to detect high-risk cases, who are typically then hospitalized—sometimes for weeks, until it’s safe to perform an early delivery.

Some of these traditional screening methods may detect fewer than 50% of all high-risk cases, according to an analysis published last year, and even the “gold standard” 24-hour urine protein test carries a sensitivity of just about 80%.

“Patients and providers will benefit from having better tests to predict progression to preeclampsia with severe features, especially for those patients at risk of severe, early-onset disease or for whom there is some diagnostic uncertainty,” Eleni Tsigas, CEO of the Preeclampsia Foundation, said in Thermo Fisher’s announcement.

Tsigas continued, “Our organization celebrates this result after many years of advocacy with leaders in research and regulatory bodies, such as the FDA, to accelerate the development and adoption of better clinical tools.”

The FDA nod came after Thermo Fisher submitted results of its Praecis study, which spanned more than 700 pregnant women at 18 hospitals across the U.S.

According to the company, the sFlt-1/PlGF ratio was proven to have a sensitivity of 94% and specificity of 75%. In a head-to-head comparison of their accuracy versus that of standard screening measures, the biomarker tests registered an area under the curve of 0.92, while the usual methods clocked in at 0.75.

“FDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns,” Ravi Thadhani, M.D., co-author of the study and executive VP of health affairs at Emory University, said in the announcement.