IMed supports SureScreen Diagnostics with speedy self-test approval for SARS-CoV-2 Rapid Antigen Self-Test –
SureScreen Diagnostics is an award-winning business providing quality rapid diagnostic equipment and services around the globe. Across Europe, every two seconds a SureScreen testing kit is being used.
SureScreen Diagnostics called on IMed’s expertise to support them in the process of gaining a CE mark for self-testing use for their SureScreen SARS-CoV-2 Rapid Antigen Test Cassette. “Their track record with similar devices and competence made them stand out in the selection process,” reports David Campbell, Director at SureScreen Diagnostics Ltd.
The product had already been supplied internationally very successfully and had gathered excellent performance reviews from clinicians and laboratories. In 2021 SureScreen made the decision to transition the device from professional use to self-testing in response to the pandemic. The business had experienced this transition with other products before but never under the same circumstances and pressure caused by the Covid-19 pandemic with lockdowns, Health Care Professional (HCP) over-stretching and difficulties accessing healthcare environments.
While typically this transition would have taken around a year, the market need was so extreme that timing was critical to make the product available to the public faster.
IMed liaised directly with regulators and specialist consultants and was able to pull together and evaluate numerous data sets from Usability and Clinical Evaluation Studies, helped to optimise the technical file and develop clear Instructions for Use for the self-test device by drawing on the specialist expertise of their team members, even supporting SureScreen in medical writing. As a result, the CE mark was granted within months, an exceptionally speedy result even under standard circumstances and an impressive result given the tough environment.
“IMed have a great team who are very knowledgeable about the regulations for IVDs, and we were able to work with them like they were an extension of our own team. They were invaluable in helping us move so quickly to address the market need. The team at IMED were always very helpful, easy to contact, and they went above and beyond to ensure that the process was as smooth as possible, and deadlines were met.
“Now that self-testing is becoming more mainstream, we expect LFTs to become an increasingly common tool for early detection, driving up the need for these devices to identify a wider range of parameters. As the regulatory environment for IVDs evolves and we continue to grow our exports, we will likely to be calling on IMed’s support to help us navigate international regulations.” Campbell declares.