Could there be a shortage of Down syndrome tests for pregnant women? The National Medicines Agency has sounded the alert about supply difficulties.
This is bad news for pregnant women. According to a press release from the National Medicines Safety Agency (ANSM), the medical tests used to detect Down syndrome in utero could be lacking due to a serious “supply voltage“.
Global supply tensions
In Europe, the free beta HCG assay tests for screening for Down syndrome, carried out by approved medical biology laboratories, are carried out with devices manufactured by the Finnish company PerkinElmer/Wallac Oy. However, these devices undergo Currently “global supply tension due to a disruption in the supply of one of their components“.
She specifies that it is a supply tension of “free beta HCG assay reagents“, used for prenatal screening for Down syndrome”on the automates AutoDelfia et Delfia Xpress et Delfia manuel/VICTOR”, marketed by the Finnish company PerkinElmer/Wallac Oy.
The problem ? These tests are absolutely essential: they make it possible to detect the risks of Down syndrome in the fetus during the first and second trimesters of pregnancy.
Without these, “The major risk is giving birth to a child who has Down syndrome.recalls Dr Ghada Hatem, obstetrician-gynecologist.
The expert nevertheless wants to be reassuring in terms of deadlines: “Postponing the test by a few weeks is entirely possible. It is not dangerous for the mother. On the other hand, postponing it for a few months would be dramatic: aborting late in pregnancy is never very “comfortable”…“.
Towards new alternatives to guarantee access to screening?
Faced with these supply tensions, the ANSM wants to be reassuring. The PerkinElmer group would in fact “implemented measures so that tension does not impact the carrying out of screenings in Europe“. He would also be able to “to cover global needs until the end of December 2023 and this period is sufficient for a return to normal in 2024“.
However, the medicines agency wishes to accelerate research and work on “new alternatives“, in order to “guarantee access to this screening for all pregnant women in Europe.”
“We have approached the Ministry of Health and Prevention and the Biomedicine Agency, in order to share information and possible solutions.”concludes the ANSM.