The iSWAB non-invasive collection devices were also approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)
Mawi DNA Technologies, a provider of biosample collection technologies, has secured CE mark approval for its iSWAB non-invasive collection devices.
The iSWAB non-invasive collection devices were also approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The approved products consist of Mawi’s HemaSure-OMICS whole blood collection tubes for gDNA, cfDNA, and RNA from the same sample, as well as the NextSWAB 100% injection molded swab.
Having secured both CE mark and UK MHRA approval, the company will now focus on commercialising its full range of products in the UK, European Union and all countries that accept this molecular diagnostic assays standard.
According to Mawi DNA Technologies CEO Dr. Bassam El-Fahmawi, both approvals enable the company to expand the use and access of its biosample collection technologies from research use only to the in vitro molecular diagnostics market in Europe.
The company is now having flexibility to collaborate and work with European companies and organisations to incorporate its products into regulated and major market segments such as molecular diagnostic testing, clinical trials, and infectious disease surveillance.
Mawi QMS and operations manager Hanzel Lawas said: “Receiving the CE Mark and UK MHRA is a great accomplishment for our company.
“Together with our recent ISO 9001/13485 certification, it reaffirms our conformity with the IVD Medical Device directives and our commitment to deliver high quality products that meet our customer’s expectations and regulatory requirements.”
Founded in 2013, Mawi DNA Technologies has developed and commercialised its iSWAB system for collection of biosamples.