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Poland has implemented spinal muscular atrophy (SMA) newborn screening using MRC Holland's CE-IVD marked SALSA MC002 SMA Newborn Screen. For the coming 1.5 years all Polish newborns (~380,000 per year) will be screened for SMA using MC002 SMA Newborn Screen.
The lab performing the experiments is positive about the assay with their Monika Gos commenting that the assay "is quite quick and can be used as a routine procedure, even if you have several plates per day to prepare". They also appreciated that there is the "possibility to run the PCR on a standard thermocycler and only use a Real-Time PCR machine to generate the Melt Curves". MRC Holland is honoured to have won this tender for SMA newborn screening.
SALSA MC002 SMA Newborn Screen detects the single clinically relevant nucleotide difference between the SMN1 and SMN2 genes to identify 95–98% of SMA patients in a fast, reliable, and affordable way. The assay can identify the presence or absence of SMN1 and SMN2 exon 7 in DNA from dried blood spot (DBS) card crude extracts or peripheral blood, and has the added advantage that SMA carriers are not identified.
MRC Holland hopes that more countries will begin implementing SMA newborn screening and turn to MC002 SMA Newborn Screen as a solution.