Trinity Biotech expects to receive emergency use authorisation to roll-out a Covid-19 test that can determine whether people immunity to the SARS-CoV-2 virus by the end of next month.
The Irish life sciences company said it is also at an advanced stage in developing a rapid point-of-care test that could diagnose cases of the virus in just 12 minutes.
The Nasdaq-listed company said it expects to have submitted validation documentation to the US Food and Drug Administration (FDA) and received emergency use authorisation for the roll-out of the immunity test, known as the Covid-19 lgG Elisa antibody test, within weeks.
The update comes as the Trinity said the pandemic had a limited impact on first quarter revenues but would likely hit second quarter figures.
Trinity recorded $21.2 million (€19.3 million) in first-quarter revenues, as against $22 million for the same quarter a year earlier. A breakdown of turnover shows clinical laboratory revenues fell 5.3 per cent to $17.8 million due largely to a reduction of sales in China, and of lower Lyme disease-related products
Point-of-case revenues rose 4.4 per cent to $3.3 million in the first quarter.
Diagnostic systems
Trinity Biotech develops, manufactures and markets diagnostic systems for the point-of-care and clinical laboratory segments of the diagnostic market. Its products are sold in more than 110 countries, and it employs more than 500 people.
The company said it booked a $2.4 million charge in the first quarter related to the closure of a facility in California, which specialises in solutions for Lyme disease.