LONDON: EKF Diagnostics Holdings announced a two year marketing and distribution agreement with Kantaro Biosciences LLC.
EKF will have exclusive rights to market and distribute COVID-SeroKlir, Kantaro’s quantitative SARS-CoV-2 IgG antibody test kit in the UK and Germany and non-exclusive rights in Europe.
Kantaro is a joint venture between the Mount Sinai Health System and RenalytixAI plc, and manufacturing partner Bio-Techne Corporation.
For the research market, EKF will have non-exclusive rights to distribute COVID-SeroIndex across the UK and Europe. Kantaro antibody testing technology supports assessment of immunity to COVID, which is a potentially critical component to maintaining the flow of commerce locally and internationally, and to understanding the effectiveness of vaccination programs.
The agreement follows the receipt of the CE Mark certification approving the use of COVID-SeroKlir and COVID-SeroIndex for detecting the presence and the precise titer (level) of IgG antibodies.
Measuring the level of neutralizing antibodies in addition to other antibodies a person produces as part of their immune response to COVID-19 virus exposure provides important information in assessing any likely protection against future re-infection.
Antibody tests are also an important component of a general health check to determine if a patient has had past COVID-19 infections, with or without symptoms, including when there has not been a positive test measuring the presence of the virus. COVID-19 has been linked to an increased risk of potentially life-threatening complications, including cardiovascular, kidney and lung disease.
“EKF’s robust footprint in regions affected by COVID-19 will allow us to get quantitative testing to patients and doctors as quickly as possible to help them assess immunity decision-making at both the individual level and for population-wide policy making,” said Sara Barrington, Kantaro’s Chief Commercial Officer.
“We believe that quantitative antibody testing will help patients and businesses take control of their healthcare choices during this uncertain time.”
Julian Baines, CEO of EKF, said: “EKF can drive rapid availability of COVID-SeroKlir kits and COVID-SeroIndex to a broad range of laboratories for immediate operation without needing specialized testing equipment. Quantitative testing can provide important support for determining public health strategies, informing healthcare decision making, and potentially verifying the effectiveness of vaccines as they become available.”
COVID-SeroKlir and COVID-SeroIndex have demonstrated 97.8% sensitivity and 99.6% specificity for detecting COVID-19 specific IgG antibodies. Its high precision results from a two-step process that utilizes two virus antigens: the full-length spike protein and its receptor-binding domain (RBD).
Both the COVID-SeroIndex and the COVID-SeroKlir tests are enzyme-linked immunoassays (ELISA), which means any clinical testing laboratory can use it in the EU without the need for proprietary equipment. The configuration of Kantaro’s COVID-SeroIndex antibody testing kits is designed to assist research efforts and support policy making both at the EU level and worldwide.
The Kantaro antibody testing technology is based on research performed at the Icahn School of Medicine at Mount Sinai in New York City.
The Mount Sinai technology has already been used in a highly diverse population of over 75,000 patient samples to screen for convalescent plasma donors and determine past infections in the clinical assessment of potentially life-threatening complications from COVID-19, including lung, kidney and cardiovascular disease.
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