Mawi DNA Technologies secures CE Certification for sample collection product portfolio

KUALA LUMPUR, March 8 -- Mawi DNA Technologies (Mawi), a leader in biosample collection technologies, has announced receiving CE Mark and UK MHRA approval for its portfolio of iSWAB non-invasive collection devices.

According to a statement, this approval includes Mawi’s HemaSure-OMICS whole blood collection tubes for gDNA, cfDNA, and RNA from the same sample and the NextSWAB 100 per cent injection molded swab.

The CE Certification, internationally recognised, signifies that Mawi’s products conform to European and UK medical device directives.

“CE Mark and UK MHRA approvals are significant milestones for Mawi. It allows us to expand the utility and access of our innovative biosample collection technologies from research use only to the in vitro molecular diagnostics market in Europe,” said Chief Executive Officer of Mawi DNA Technologies, Dr Bassam El-Fahmawi.

“Further, it opens opportunities to collaborate and partner with European companies and organisations to integrate our products into regulated, high-value market segments such as molecular diagnostic testing, clinical trials, and infectious disease surveillance.”

Meanwhile, QMS and Operations Manager at Mawi, 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.”

With CE Mark and UK MHRA approval, Mawi is able to commercialise its full range of products in the UK, European Union and all countries recognising this molecular diagnostic assays standard.

More details at http://www.mawidna.com.

-- BERNAMA