Medakit Ltd, a leading biotech company specialized in the production of antibody diagnosis tests for COVID-19, received on June 10th a warning letter from the Food and Drug Administration outlining their concern regarding the terminology utilized in Medakit website allegedly suggesting the use of Medakit test for " home-use” settings.
HONG KONG /PRNewswire/ -- Medakit Ltd, a leading biotech company specialized in the production of antibody diagnosis tests for COVID-19, received on June 10th a warning letter from the Food and Drug Administration outlining their concern regarding the terminology utilized in Medakit website allegedly suggesting the use of Medakit test for “home-use” settings. In addition, the Food and Drug Administration notified Medakit that some of its products were found to be distributed in the United States despite the company not having premarket approval to market its tests in the country.
These allegations were promptly responded to on June 12th, and Medakit presented a series of immediate measures taken to correct any misunderstanding and to ensure none of its products mistakenly reach the United States.
Medakit does not have any authorized distributors in the United States nor has the intention, at the moment, to market COVID-19 diagnosis tests in the United States. Any and all sales in the country are prohibited by Medakit, evidenced by its Terms of Service contained in the company’s website. Despite that, Medakit has immediately responded in good faith to the requests of the regulators outlining a set of corrective steps to address the issues found by the FDA. These steps include the review and alteration of labelling, marketing, advertisement and marketing material to confirm that the product is only intended to be used by professionals. In addition, a clear disclaimer stating that Medakit products are not intended for the United States’ market has been added to the website and technical procedures were instituted to prevent any direct online purchase to reach the United States.
Additionally, Medakit has been informed that some organizations are fraudulently using Medakit’s name, logo and reputation to illegally promote and distribute counterfeit COVID-19 tests. Medakit implemented a tracking code on every COVID-19 test kit to ensure the authenticity and history of any device.
The company continues to focus its efforts in Asia, Europe and South America by assisting governments, armies, health agencies and professionals providing them a leading point-of-care antibody COVID-19 test that has been independently verified by world-renowned Institut Pasteur in Paris, France.
A study led by the Institut Pasteur confirmed an extremely high accuracy, reaching 100% of IgM & IgG sensitivity between 14 and 19 days after the first symptoms and a specificity of 100%. Medakit is one of the only diagnosis companies to have ever reached that level of accuracy. “We are extremely proud of what we have achieved in such a short period of time. Until we find a vaccine, we all need access to testing. Medakit’s mission is to make ultra-accurate testing accessible and scalable to the regions that need it the most. We have a production capacity of 800,000 tests per day, which is enough to supply testing for a whole country within 24 hours.” Said Mike Touzard, Medakit’s CEO.
Medakit welcomes any official request for analyzing its Covid-19 antibody tests, in order to confirm the given data.
Finally, Medakit remains committed to the highest level of compliance with regulatory requests by any authority and is available for further requests by any of these bodies.
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SOURCE Medakit Ltd
