Why the Dotz Nano (ASX:DTZ) share price is up 11%

The Dotz Nano Ltd (ASX: DTZ) share price is up 10.91% after good regulatory news for the company's COVID-19 testing kits. Here's the lowdown.

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Dotz Nano Ltd (ASX: DTZ) shares are on the rise today after the company announced its saliva-based COVID-19 testing kit has received approval for use in the European Union (EU). At the time of writing, the Dotz Nano share price is trading 10.91% higher at 30.5 cents.

By comparison, the All Ordinaries Index (ASX: XAO) is up 0.42%.

Let's take a closer look at what the company announced.

Approval to sell testing kits in Europe

The Dotz Nano share price is racing today after the company advised the EU has granted it permission to use the CE Mark on its COVID-19 saliva testing kits.

The CE Mark is a requirement to sell medical products in the EU. Some EU countries will also have additional regulatory hurdles to clear. The pan-European governmental organisation previously granted Dotz Nano the right to use the CE Mark for its nasal swab testing kit.

With the company's saliva-based kit, a sample of saliva is swabbed from the inside of a person's mouth. After no longer than 17 minutes, the kit will indicate whether or not the test subject is carrying the novel coronavirus. This is much less intrusive than the nasal swab test, which involves one swab in each nostril, up to the sinus, and a swab of the recipient's throat. The results are also many times faster than the nasal swab test. Nasal swabs must be sent to a lab for processing and can take up to 48 hours to deliver results. 

According to Dotz Nano, the kit has a 0% false-negative rate for saliva samples containing a viral load of at least 1,250 copies per millilitre (mL). Samples containing as few as 313 virus copies per mL will induce a false-negative rate of 30%.

The test does not produce false-positive results, according to the statement.

Europe is entering a third wave

The approval of the testing kit could not come at a better time for European citizens. According to the New York Times, Europe is entering a third wave of coronavirus infections. The rise in COVID cases comes at the same time many European nations suspended the use of the AstraZeneca vaccine over blood clotting fears.

France, Germany, Italy, Poland, Greece, Czechia, Spain, Belgium, Ireland, and many other EU nations are tightening restrictions on gatherings, businesses, and general movement in response to the increasing cases.

The testing kits may also be music to the ears of many Australians still stranded in Europe. It is currently a requirement of the Australian Government that anyone flying into the country must test negative to the virus at least 72 hours before departing.

Dotz Nano share price snapshot

Over the last 12-months, the Dotz Nano share price has increased a remarkable 662.5%. Today's share price high is only half a cent off from the company's 52-week record.

Dotz Nano has a market capitalisation of around $103 million.

Motley Fool contributor Marc Sidarous has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.

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