EKF partner Kantaro gets FDA authorisation for Covid-19 test
Point-of-care company EKF Diagnostics updated the market on developments at its partner Kantaro Biosciences on Thursday, confirming that it had received Emergency Use Authorization from the US Food and Drug Administration (FDA) for ‘COVID-SeroKlir’, its semi-quantitative SARS-CoV-2 IgG antibody test kit.
The AIM-traded firm has exclusive rights to market and distribute COVID-SeroKlir in the UK and Germany, and non-exclusive rights in the rest of Europe.
It said Kantaro Biosciences, which is a joint venture between the Mount Sinai Health System and RenalytixAI, received Emergency Use Authorization on 25 November.
The company said that, unlike other antibody tests, COVID-SeroKlir determined the presence and precise level of IgG antibodies, and had a “broad range” of applications in the fight against Covid-19.
Through a commercial partnership with Bio-Techne Corporation, the test kits were being manufactured at scale, with a capacity of up to 10 million tests per month and the ability to scale up.
COVID-SeroKlir demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2-specific IgG antibodies against two virus antigens, being the full-length spike protein and its receptor-binding domain.
The test was described as a two-step enzyme-linked immunosorbent assay, which could be used by any CLIA-certified laboratory without the need for proprietary equipment.
It received CE-mark certification in October, and was available in 29 countries in Europe.
"COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the Covid019 pandemic in New York City," said Kantaro chief commercial officer Sara Barrington.
“It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust.
“Having a numerical understanding of antibody levels can be especially powerful for patients, enabling them to take control of their health and enjoy some peace of mind during these uncertain times.”
Measuring IgG antibody levels with COVID-SeroKlir could inform healthcare decision-making and public health strategies, Kantaro said, as well as assess vaccine response.
T described semi-quantitative antibody testing as an “essential component” of a general health check to determine past Covid-19 infections.
At 1237 GMT, shares in EKF Diagnostics Holding were up 5.37% at 63.75p.