HAYWARD, Calif.--(BUSINESS WIRE)--Mawi DNA Technologies (Mawi), a leader in biosample collection technologies, announces the company received CE Mark and UK MHRA approval for its portfolio of iSWAB non-invasive collection devices. This approval includes Mawi’s HemaSure-OMICS whole blood collection tubes for gDNA, cfDNA, and RNA from the same sample and the NextSWAB 100% injection molded swab.
The CE Certification, internationally recognized, signifies that Mawi’s products conform to European and UK medical device directives. With CE Mark and UK MHRA approval, Mawi is able to commercialize its full range of products in the UK, European Union and all countries recognizing this molecular diagnostic assays standard.
“CE Mark and UK MHRA approvals are significant milestones for Mawi,” said Dr. Bassam El-Fahmawi, CEO of Mawi DNA Technologies. “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. “Further, it opens opportunities to collaborate and partner with European companies and organizations to integrate our products into regulated, high-value market segments such as molecular diagnostic testing, clinical trials, and infectious disease surveillance.”
“Receiving the CE Mark and UK MHRA is a great accomplishment for our company,” Hanzel Lawas, QMS and Operations Manager at Mawi, said. “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.”
About Mawi DNA Technologies
Mawi DNA Technologies, founded in 2013, has developed and commercialized the iSWAB technology, an innovative system for collection of biosamples. Mawi’s mission is to uphold sample integrity from anywhere in the world at room temperature, enabling true sample diversity across any geography or population segment. At Mawi, The Future of Biosampling is Here™. For more information, visit http://www.mawidna.com.