Spectrum Solutions, LLC today announced receiving CE Mark approval for the sale and distribution of its groundbreaking SDNA saliva collection device for IVD molecular diagnostic testing throughout Europe. The European CE Mark represents a standard of excellence and regulatory validation required to sell medical devices within the European Economic area. The equivalent mark within the United States would be an FDA medical device 510k approval. This mark demonstrates a conformity with health, safety, and environmental protection standards for products sold within Europe. The Spectrum SDNA-2000 model has been approved for integration in over the counter at-home testing kits with the SDNA-3000 model approved for prescription-only molecular diagnostic IVD testing applications.
“Receiving CE Mark approval for the SDNA-2000 and SDNA-3000 is a major milestone for our company and this offers physicians, healthcare organizations, governments, and individuals needing repeat IVD diagnostic testing an easy and pain-free option,” said Stephen Fanning, CEO of Spectrum Solutions. “At-home bio-sample self-collection means staying home when you don’t feel good and limiting exposure to other harmful illnesses for those most at risk.”
The Spectrum Solutions SDNA Saliva Collection Device was the first saliva-based diagnostic testing solution to receive the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for COVID-19 testing in the United States.
Bio-samples collected with the SDNA saliva collection system consistently demonstrate higher levels of testing accuracy, provide the safest & most robust testing biomaterial, is able to pinpoint an infection’s lifecycle stage, and delivers over 10 days of post-collection stability with no degradation in sample efficacy. The device’s intuitive ease-of-use design was engineered to facilitate unsupervised testing sample self-collection virtually eliminating user collection errors.