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- Authentication company Dotz Nano (DTZ) has obtained CE Mark approval for its SARS-CoV-2 virus detection technology
- This mark allows Dotz’s saliva-based test kits to be sold across the majority of the European Union
- According to the company, saliva-based tests are less intrusive than current sampling methods and more simple, convenient and cost efficient
- Additionally, results are received within 15 to 17 minutes when using heating blocks and multiple tests can be sampled at the same time
- Dotz is up 7.27 per cent on the market on the back of this news with shares trading at 29.5 cents
Authentication company Dotz Nano (DTZ) has obtained CE Mark for its SARS-CoV-2 virus detection technology.
This mark allows Dotz’s saliva-based test kits to be sold in the majority of the European Union.
In the countries where CE Mark approval has not been obtained, Dotz will need to comply with rules and obligations in those areas.
According to the company, saliva-based tests are less intrusive than current sampling methods and more simple, convenient and cost efficient.
Additionally, results are received within 15 to 17 minutes when using heating blocks and multiple tests can be sampled at the same time.
Dotz now has CE Mark approval for two COVID tests, the first of which is a nasopharyngeal swab — the most common testing method.
These saliva kits are expected to retail between US$5 and US$6 (around A$6.48 and A$7.77) and cost around US$2 (around A$2.59) to produce.
Given the uncertainty of the COVID pandemic, Dotz has not budgeted any material revenue and is not able to prepare a budget at this moment.
Before Dotz can apply for an Emergency Use Authorisation from the Food and Drug Administration (FDA), it will need to test 30 SARS-CoV-2 positive patients.
The company has begun a clinical trial of its test with pharmaceutical company Excelya in Greece.
Additionally, Dotz has begun preparing its FDA submission for its test kits, which is expected to be submitted by the end of the month.
Dotz is up 7.27 per cent on the market on the back of this news with shares trading at 29.5 cents at 2:02 pm AEDT.
