Tepnel Gains Canadian IVD Approval of its Prenatal DNA Test for Chromosome Abnormalities
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Tepnel Life Sciences PLC has announced hat it has been granted approval from the Medical Devices Bureau, Health Canada to sell its ELUCIGENE™ QST*R™ product for human in vitro diagnostic use throughout Canada.
ELUCIGENE™ QST*R™ is a prenatal DNA-based diagnostic assay which is designed to detect common chromosome abnormalities including those responsible for: Down syndrome, Edwards syndrome and Patau syndrome.
Developed in collaboration with Guy’s and St Thomas’ NHS Foundation Trust, ELUCIGENE™ QST*R™ is PCR based product for detection of chromosome aneuploidy to be approved for IVD use in Canada.
"Traditionally, chromosome aneuploidies are diagnosed by conventional and time consuming karyotyping analysis," said Ben Matzilevich, CEO of Tepnel.
"ELUCIGENE™ QST*R™ state-of-the-art testing technology provides a rapid and cost effective alternative."
"This approval marks a great success for our diagnostics business and acknowledges the further international recognition and validation of our valuable technologies and resources."