Mymetics Corp (MYMX)

[Work Harder]

You gotta recognize when that fella

is FOS

It hasn't been done for Hiv, influenza yet, right ?

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Why are rapid SARS-CoV-2 antigen tests not tested and certified before they are marketed, as is done with HIV tests?

Pursuant to the currently applicable EU Directive for in vitro diagnostic devices (IVD), tests for the human immunodeficiency virus (HIV) rank among the category of high risk products, and are therefore subject to the certification by a Notified Body. COVID-19 tests are currently still categorised as “low-risk IVDs”, and as such, can be certified by the manufacturers themselves. They do not require independent testing before they can be marketed. SARS-CoV-2 self tests are an exception to this. For these tests, it is required that a Notified Body reviews certain aspects or that the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) grants a special authorisation (see below).

The future IVD Directive, the implementation of which will be compulsory as from May 2022, requires an EU reference laboratory and a Notified Body to be consulted for the testing of SARS-CoV-2 tests. For this purpose, a laboratory assay and an independent verification of the data will be required for the tests.

The Paul-Ehrlich-Institut is preparing to apply for its role of one of the EU reference laboratories in order to review high risk tests in the laboratory.

The Paul-Ehrlich-Institut welcomes the classification of tests such as SARS-Co-2 antigen tests and their independent review und evaluation, as planned as from May 2022. This will increase the safety of and confidence in these in vitro diagnostic devices.