NEW YORK – Medicover Genetics on Monday announced that its next-generation sequencing-based TarCET genetic testing kit has received certification under Europe's In Vitro Diagnostic Regulation.
The reagent kit, along with the firm’s UltraVerse Index Oligos that go with it, has been categorized as Class A, the lowest-risk class. The kit contains a "comprehensive suite of panels covering a range of genetic conditions" including metabolic disorders, cardiovascular diseases, hereditary cancers, infertility, and neonatal screening, the company said in a statement.
The reagent kit includes library preparation and targeted capture enrichment and is intended for use with genomic DNA from human cells. It can be used to target specific regions of the genome with validated DNA hybridization probe panels that are supplied in the kit.
The IVDR certification "underscores our commitment to advancing genetic science while ensuring the highest standards of safety and quality," Stefan Mehrle, head of Medicover Genetics, said in a statement.
Medicover Genetics, formerly NIPD Genetics, is based in Cyprus. It is part of healthcare and diagnostic services company Medicover, which acquired a majority stake in the firm in 2021.