Omega Diagnostics (LSE:ODX) has completed the final stage of the CE marking procedure for its VISITECT Covid-19 antigen testing kit. The submission process was running in parallel with a useability study by Ulster University. This study has now been completed, and the CE marking application submitted.
So what?
A CE marked product indicates that the manufacturer has met all regulatory and safety requirements to distribute its products throughout Europe. For a healthcare company like Omega Diagnostics, receiving regulatory approval for its products is a must.
VISITECT has already been CE marked for professional use. However, this latest application is to allow individuals to self-test. The approval of home usage significantly expands the firm’s reach and addressable market size. Consequently, if it’s granted, the Omega Diagnostics revenue stream is set to grow rapidly.
How does this impact the ODX share price?
Following this announcement, the ODX share price only increased slightly by around 1%. Why? Because the submission of an application does not guarantee approval. The application reviewing process typically takes four to six weeks.
Should regulators not be satisfied with VISITECT, Omega Diagnostics will have to spend more time developing and improving its product to meet regulatory requirements. This delay will likely have a negative impact on the stock and potentially create an opportunity for competitors. However, if the Covid-19 testing kit is approved for home use, the ODX share price may begin to rise considerably.