NEW YORK – Mawi DNA Technologies said on Monday that its portfolio of sample collection devices has received CE marking and approval from the UK's Medicines and Healthcare products Regulatory Agency.
The regulatory approvals cover the firm's iSwab noninvasive collection devices, including its HemaSure-Omics whole blood collection tubes for DNA, cell-free DNA, and RNA extraction from the same sample, and its NextSwab 100 percent injection-molded swab.
The approvals will allow Hayward, California-based Mawi to expand access to its products from the research-use-only market to the in vitro molecular diagnostics market in Europe, CEO Bassam El-Fahmawi said in a statement.
"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," El-Fahmawi added.
Last month, the firm announced it had received two ISO certifications, ISO 9001:2015 Quality Management Systems and ISO 13485:2016 Medical Devices Quality Management Systems. In October, Mawi signed a distribution agreement for its iSwab biosampling products in Japan with Fujifilm Wako Pure Chemical.