NEW YORK — Imspex Diagnostics recently announced it has gained a CE mark for its breath-based test for detecting COVID-19.
The Wales, UK-based firm's BreathSpec instrument uses a combination of gas chromatography and ion mobility spectrometry to aid diagnosis of respiratory tract infections and is intended for use in point-of-care settings. The company said the noninvasive sample collection method is particularly helpful in testing children and other challenging patients.
The company gained the CE mark under the In Vitro Diagnostics Directive, which predates the current In Vitro Diagnostics Regulation.
Imspex said the results of BreathSpec COVID-19 tests correlate with polymerase chain reaction test results but more quickly and at a lower cost.
Other firms have also been developing breath-based COVID-19 tests. In April, the US Food and Drug Administration granted InspectIR the first Emergency Use Authorization for a SARS-CoV-2 virus breath test.