Health Canada licenses four prenatal screening assays for risk assessment of fetal trisomies and pre-eclampsia
B·R·A·H·M·S Biomarkers Receive Class III Medical Device System License for Prenatal Screening

WALTHAM, Mass., Feb. 15, 2018 /PRNewswire/ -- B·R·A·H·M·S GmbH, a part of Thermo Fisher Scientific Inc., today announced that its sFlt-1, PlGF plus, PAPP-A and Free βhCG KRYPTOR assays have received Class III Medical Device System License from Health Canada as an aid in screening for the risk of fetal trisomy 21, 18 and 13 as well as preeclampsia in first trimester of pregnancy, and the diagnosis and short-term prognosis of suspected preeclampsia (PE) after week 20 of pregnancy. The approval to use these assays will assist clinicians in an early risk assessment of PE and the most common fetal genetic abnormalities in the first trimester of pregnancy and can also help in better identifications of women suffering from PE later in pregnancy.

PE, also known as pregnancy poisoning, is a disorder that affects two to eight percent of all pregnancies. In Canada, five percent of pregnant women are diagnosed with PE each year, which amounts to approximately 20,000 cases. PE is one of the primary causes of preterm birth, and can lead to severe complications for both the mother and baby not only during pregnancy but also on long-term perspective. Previously, PE could go undiagnosed until complications arose but  the newly licensed PlGF plus, PAPP-A and sFlt-1 B·R·A·H·M·S KRYPTOR assays allow clinicians to perform early risk assessment to identify women at risk of developing preeclampsia and start treatment before complications arise. Prof. Emmanuel Bujold, University Laval of Quebec, explains, "Recent data indicates early treatment substantially delays the risk of developing PE and lowers chances of severe complications. Results from the ASPRE trial1, the largest multicenter trial to be conducted on prophylactic use of low-dose aspirin, showed that low-dose aspirin administered to women identified as high risk for PE by 16 weeks of gestation reduced the incidence of preterm PE by more than 60 percent. The PlGF plus and PAPP-A assays can be easily integrated into clinical routine pregnancy assessments in the first trimester."

If a woman has suspected PE after 20 weeks of pregnancy, the sFlt-1 and PlGF assays can be used to confirm and diagnose. These assays can also be integrated into routine second trimester assessments. Diagnosis in the second trimester is important, as doctors can appropriately monitor the pregnancy and act fast when complications arise.

Trisomy 21, 18 and 13, also known as Down syndrome, Edwards syndrome and Patau syndrome respectively, are severe conditions that have a significant impact on the baby's life. By completing a combined screening approach of biomarkers Free βhCG, PlGF plus and PAPP-A, ultrasound measures and maternal history during weeks eight through 14 of pregnancy, over 90 percent of fetal trisomy 21 cases and 95 percent of pregnancies affected by trisomies 18 and 13 can be identified. Early identification of these trisomies help the expecting parents better prepare for the significant life changes that need to be made to accommodate babies with these syndromes. In addition to being comprehensive and cost-effective, these assays further reduce unnecessary invasive tests to detect risk.

"Pregnancy is an exciting time for women and their families and it is important that both expectant mothers and their clinicians take the necessary steps to ensure a healthy pregnancy," said Pascaline Caruhel, global marketing manager at Thermo Fisher Scientific. "The portfolio of B·R·A·H·M·S KRYPTOR assays fulfill the strict quality requirements of the Fetal Medicine Foundation (FMF) and are considered the gold standard in first trimester prenatal screening in Europe since 1999."

"With PE impacting such a significant number of women in Canada and worldwide, we understand the need to provide clinicians with the necessary tools for prenatal screening of diseases and conditions that may impact the well-being of mother and fetus," says Prof. Bujold, "We are thrilled that these assays have been approved for use in Canada and are confident that it will have a similar impact on screening for pre-eclampsia and trisomies as they have had in Europe."

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1 Rolnik DLet al, N Engl J Med. 2017 Aug 17;377(7):613-622