Thermo Fisher wins FDA approval for preeclampsia blood test
Sundry Photography/iStock Editorial via Getty Images
Update 10:40 AM EST: Adds remarks from Thermo Fischer
Thermo Fisher Scientific (NYSE:TMO) announced Friday that the FDA greenlighted two of its biomarkers as the first and only blood-based immunoassays to assess the risk of severe preeclampsia, a pregnancy complication characterized by high blood pressure.
The tests named B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR are designed to use alongside other lab tests and clinical evaluations to determine if a pregnant mother hospitalized with hypertension can develop severe forms of preeclampsia within the next two weeks.
Previously: For the first time, the FDA has greenlighted a blood-based test to measure the risk of severe preeclampsia during pregnancy, The Wall Street Journal reported Thursday, citing the product's developer, Thermo Fisher Scientific (TMO).
Preeclampsia, marked by high pressure, typically occurs after 20 weeks of pregnancy, and the condition is a common cause of pregnancy-linked illness and death.
The Waltham, Massachusetts-based life sciences company, already markets the test in Europe. According to doctors and maternal-health advocates, the product, soon-to-be-launched in the U.S. following the FDA nod, can transform prenatal care nationwide.
The preeclampsia laboratory testing market is expected to grow by $785.7M during 2022-2027, Infiniti Research estimates, indicating a compound annual growth rate of 8% over the period. Thermo Fischer (TMO) was not available for comments on pricing and projected sales of the test.