NEW YORK (360Dx) – Thermo Fisher Scientific said today that Health Canada has granted a Class III Medical Device System License to its BRAHMS business for four automated immunofluorescent assays to be used as aids in prenatal screening.
The agency granted approval for use of the BRAHMS sFlt-1, PlGF plus, PAPP-A, and Free βhCG Kryptor assays. They can be used to screen for the risk of preeclampsia in the first trimester of pregnancy as well as for fetal trisomy 21, 18, and 13, known as Down syndrome, Edwards syndrome, and Patau syndrome, respectively. The assays are also approved for the diagnosis and short-term prognosis of suspected preeclampsia after week 20 of pregnancy, Thermo Fisher added.
It added that the approval of the assays could help clinicians better identify women suffering from preeclampsia later in pregnancy and start treatment before complications arise.
Preeclampsia, known as pregnancy poisoning, affects 2 to 8 percent of all pregnancies, and in Canada, 5 percent of pregnant women, about 20,000, are diagnosed with the disorder each year, Thermo Fisher noted. It is also among the primary causes of preterm birth and can lead to "severe complications" for the mother and baby not only during pregnancy but also long-term, the firm added.
Emmanuel Bujold, a professor at the University Laval of Quebec, said in a statement that recent data indicates early treatment "substantially delays the risk of developing [preeclampsia] and lowers chances of severe complications." He noted that results from a large multicenter trial showed that low-dose aspirin administered to women identified as high risk for preeclampsia by 16 weeks of gestation reduced the incidence of preterm preeclampsia by more than 60 percent.
Bujold added that the PlGF plus and PAPP-A assays can be easily integrated into clinical routine pregnancy assessments in the first trimester. The sFlt-1 and PlGF assays can be used to confirm and diagnose whether a woman has suspected preeclampsia after 20 weeks of pregnancy, Thermo Fisher said.