The approval enables to integrate Spectrum SDNA-2000 model of the device with over the counter at-home testing kits
Spectrum Solutions has secured CE mark approval for its SDNA-2000 and SDNA-3000 saliva collection devices for IVD molecular diagnostic testing across Europe.
The approval enables to integrate Spectrum SDNA-2000 model with over the counter at-home testing kits.
The company has secured CE mark approval for SDNA-3000 model for prescription-only molecular diagnostic IVD testing applications.
Spectrum Solutions stated: “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.”
Spectrum’s SDNA saliva collection device is claimed to be the first saliva-based diagnostic testing solution to secure emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for Covid-19 testing in the US.
The self-contained saliva collection kit offers critical sample consistency, as well as suspends and neutralises viral RNA transcripts to completely inactivate the live virus.
Spectrum stated that the device’s ease-of-use design has been developed to facilitate unsupervised testing sample self-collection, thereby helping to eliminate user collection errors.
Spectrum Solutions CEO Stephen Fanning said: “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.
“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.”
Based in Salt Lake City of Utah, Spectrum Solutions offers on-site medical device development and manufacturing, custom packaging, kitting, and direct-to-consumer fulfilment services.