The First Test To Detect Preeclampsia From Thermo Fisher Gets FDA Approval

The FDA has reportedly approved Thermo Fisher Scientific Inc's TMO blood test for preeclampsia, which causes pregnancy-related illness and death, to aid in the risk assessment of pregnant women within the next two weeks. 

It is the first and only blood-based biomarker immunoassay to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia.

Preeclampsia is a serious blood pressure condition that develops during pregnancy. In addition to causing high blood pressure, it can cause organs, like the kidneys and liver, to not work normally.

The rate of first-time hypertensive disorders in pregnancy nearly doubled from 2007 to 2019, Wall Street Journal noted. Rising rates of obesity and hypertension before pregnancy are likely drivers, doctors, and researchers said.

Thermo Fisher's test is meant for mothers with high blood pressure or mild preeclampsia admitted to a hospital for observation, is already available in Europe and could soon be available in the U.S.

Testing of the blood-based biomarkers was looked at in over 700 women.

In a study of the test submitted to the FDA, women whose ratio of proteins fell below the threshold had less than a 5% chance of developing severe preeclampsia within two weeks. Women above the threshold had a 65% chance of developing severe preeclampsia. 

Thermo Fisher did not discuss the pricing or projected sales.

Price Action: TMO shares closed at $523.54 on Thursday.