Anvisa suspends sale of unauthorized Covid self-test

Anvisa (National Health Surveillance Agency) suspended the distribution, commercialization, manufacture and advertising of the “myDNA PCR-LAMP Autocoleta de Saliva” self-test.

The measure was taken by the regulatory agency because the product is not regularized at Anvisa. The manufacture is done by the Mendelics Genomic Analysis Laboratory.

Anvisa authorized the sale of self-tests in Brazil. However, each company must apply for registration with the regulatory agency to market the product.

There is still no self-test approved for sale in Brazil. Anvisa has already rejected ten requests made by the companies.

Only after this approval can the self-test be sold in pharmacies and licensed health establishments. These licensed establishments will also be able to sell online.

The resolution was published in the Official Gazette on Tuesday (15).

“This measure was due to the disclosure of the respective product on the laboratory’s website on the internet. Mendelics is also the laboratory responsible for manufacturing the kit and the holder of the meuDNA brand”, he said in a statement.

The company was contacted, but did not respond until the publication of this report.

In January of this year, the regulatory agency had already published four other resolutions against the companies Pague Menos, Drogaria São Paulo, Drogarias Pacheco and Raia Drogasil, which were also promoting the product.

In January, the leaf showed that internet sales of PCR-Lamp tests, which can be done at home, were 10% higher in the first five days of January than in the entire month of December 2021.

In this test modality, the person receives the material and collects about 5 ml of saliva. After that, the responsible company takes the sample at home and makes the result available online within 24 hours.