- 14 July 2021 14:33
Dotz receives $2.8m COVID-19 test kit order
Dotz Nano Limited (ASX:DTZ) has received an initial US$2.1 million (A$2.8 million) purchase order from, and entered into a distribution agreement with, UAE-based Hygiene Links International General Trading LLC for its SARS-CoV-2 virus detection technology.
The US$2.1 million purchase order is for the supply over the next six months of Dotz’s saliva-based and nasopharyngeal swab COVID-19 test kits for use in the UAE, Egypt and Sudan. The two-year distribution agreement with an option to extend grants Hygiene Links the exclusive right to sell the Dotz test kits in these countries, subject to Hygiene Links satisfying a minimum order of 50,000 units per month for a six-month period for each country. Kits will be shipped monthly with 50 per cent of each monthly shipment fee paid upfront and the remaining 50 per cent on delivery.
Headquartered in Dubai, Hygiene Links is a leading chemical, plastics and consumables manufacturer and distributor across the Middle East with a large healthcare customer base. It is increasing its offer to include health care and personal protective equipment (PPE) products. The Dotz test kits are expected to be among the first of Hygiene Links’ new product offer.
The purchase order and distribution agreement follow a successful blind clinical trial of the nasopharyngeal swab Dotz test kits in the USA. The kits have obtained CE Mark authorisation for both nasopharyngeal swab and saliva-based samples, which clears them for sale in the European Union and the private sector in the UAE, Egypt and Sudan - however, regulatory requirements still need to be satisfied before the kits can be sold to the public sector in these countries. Dotz has applied for a FDA Emergency Use Application for its nasopharyngeal swab test kits and updated its existing FDA EUA application to cover its saliva-based kits.
Dotz said in a statement to the ASX that based on Hygiene Links’ reputation and its due diligence and present business dealings with the company, that it is confident with the financial and other capacity of Hygiene Links to meet its obligations under the distribution agreement. As part of its due diligence, Dotz has obtained various references in relation to Hygiene Links, its management team and key shareholders and has also undertaken certain KYC verification requirements. Dotz has also considered the sanctions in place for Sudan by Australia (and other relevant countries) and is satisfied that the sanctions do not impact the distribution agreement, noting Hygiene Links is UAE based.
Dotz Chairman and Interim CEO Bernie Brookes said, “Our first commercial order within the diagnostic domain is a significant achievement for Dotz. It reflects the versatility of our technology, which has applications within almost every industry. We believe our virus detection technology is truly industry-leading, providing a method to accurately identify the SARS-CoV-2 virus at scale and in a cost-effective and timely manner. While we are awaiting FDA regulatory approval for the nasopharyngeal swab and saliva-based Dotz Test Kits, our successful clinical trial of the nasopharyngeal swab Dotz Test Kits and CE Mark authorisation has enabled us to start to engage with a number of potential customers. At the same time we are continuing to commercialise our anti-counterfeiting technology, and applying for regulatory approval for the Dotz Test Kits in other markets.”
The kits are being manufactured in Virginia, USA by Systaaq Diagnostic Products who will export the kits to the UAE under a non-exclusive manufacturing agreement. The manufacturing agreement has a five-year term with Systaaq agreeing to have capacity to manufacture at least three million Dotz test kits in the first 12 months to the extent required by Dotz.