Roche has obtained CE mark for its SARS-CoV-2 Antigen Self Test Nasal, which can be used for rapid testing of Covid-19 in an at-home setting using a nasal swab.
The test is a chromatographic immunoassay or lateral flow assay indicated for identifying the SARS-CoV-2 nucleocapsid protein in human nasal specimens and delivers results in 15 minutes.
Since February, a first version of this assay has been available for at-home use in various European markets under special approval pathways.
With the latest CE mark, the test will now be introduced in markets with no established regulatory exemption pathways.
The assay’s clinical performance was evaluated by head to head comparison with Roche’s reverse transcriptase-polymerase chain reaction (RT-PCR) test using nasopharyngeal swab specimens as a comparator.
According to combined study data, the SARS-CoV-2 Antigen Self Test Nasal showed a 91.1% relative sensitivity and overall relative specificity of 99.6 %.
Roche noted that the assay, which is part of an alliance with SD Biosensor, will be sold in packs of five tests in countries accepting the CE mark.
Each test comes with a unique QR code to aid people in sharing results and vaccine status using the company’s digital solution, NAVIFY Pass.
Roche Diagnostics CEO Thomas Schinecker said: “As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic.
“Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to seek medical advice, manage their infection and protect others.”
In March, Roche signed a definitive merger agreement to completely acquire GenMark Diagnostics for a total transaction value of nearly $1.8bn.
Separately, Weavr Health has sought emergency use authorisation from the US Food and Drug Administration for its Silk COVID-19 Rapid Antibody Test.
This could potentially be the first at-home Covid-19 antibody test which would rapidly assess for IgG and IgM antibodies, delivering results in just ten minutes.