Dotz Nano (ASX:DTZ) applies to FDA for emergency approval

• Dotz Nano (DTZ) has submitted its SARS-CoV-2 virus detection technology to the U.S. Food and Drug Administration (FDA) for an emergency use authorisation
• The authorisation would enable DTZ to sell and distribute its test kits within the U.S., where it says the average number of COVID-19 tests exceeds one million per day
• As part of the application, Dotz was required to complete clinical trials in at least 30 COVID-19 positive and 30 COVID-19 negative subjects with a broad range of viral loads
• The results showed 96.77 per cent positive agreement and 100 per cent negative agreement between the the test kit and an FDA-required diagnostic panel
• The results also recorded 100 per cent “specificity”, meaning the kit was able to detect SARS-CoV-2 without being triggered by other viruses
• DTZ achieved CE Mark authorisation for its technology in Europe in March
• Dotz Nano shares are down 1.33 per cent, trading at 37 cents each

Dotz Nano (DTZ) has submitted its SARS-CoV-2 virus detection technology to the U.S. Food and Drug Administration (FDA) for an emergency use authorisation (EUA).

The EUA would enable Dotz to sell and distribute its technology (the Dotz Test Kit), in the above capacity, within the U.S. market, where it says the average number of COVID-19 tests is exceeding 1 million per day.

The technology has the ability to return results within 17 minutes and can simultaneously test up to hundreds of samples.

Clinical trial of the Dotz Test Kit

Dotz Nano, as part of its application to the FDA, was required to complete a clinical trial of at least 30 COVID-19 positive and 30 COVID-19 negative subjects with a broad range of viral loads.

Caerus Theraputics, on behalf of DTZ, first tested the positivity of patient nasopharyngeal swab samples using Dotz’s virus detection technology.

It then confirmed the results using the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, in accordance with FDA requirements.

The results

An evaluation of 73 subjects in the U.S. identified 31 positive patient samples and 42 negative samples.

Notably, the blinded clinical trial resulted in 96.77 per cent positive agreement and 100 per cent negative agreement between the Dotz Test Kit and diagnostic panel.

The research recorded a limit of detection of 2500 copies per millilitre as well as 100 per cent “specificity”, which refers to the technology’s ability to identify SARS-CoV-2 without being triggered by other viruses.

Pending EUA application

The Dotz Test Kit previously obtained CE Mark authorisation for both nasopharyngeal swab and saliva-based samples back in March, clearing it for sale in most countries within the European Union.

However, in an effort to simplify the application process in the U.S., DTZ’s current EUA application is based solely on nasopharyngeal/oropharyngeal swab samples.

Pending FDA negotiations, Dotz intends to make a secondary EUA application in respect of saliva samples by the end of the month, which could potentially require further clinical trials.

Dotz Chairman and Interim CEO Bernie Brookes commented on the company’s pending EUA application.

“We are encouraged by the results of our blinded clinical trial, which demonstrated the effectiveness of our Dotz Test Kits in correctly identifying the SARS-CoV-2 virus,” he said.

“If the company’s FDA EUA application is successful and [authorisation] is obtained, such will enable Dotz to sell and distribute its virus detection technology, in respect of nasopharyngeal and oropharyngeal swab samples, within the large U.S. market…which is currently experiencing an average of more than 1 million COVID-19 tests per day,” the chairman added.

Presently, DTZ is unable to determine whether or when the FDA might approve its application.

Dotz Nano shares are down 1.33 per cent, trading at 37 cents at 4:35 pm AEST.