Anteotech Ltd (ASX: ADO) shares are shooting upwards today after the company announced it has received an important manufacturing contract. At the time of writing, the Anteotech share price is trading 10% higher at 33 cents.
Anteotech is an Australian based biotech company that aims to solve global industry problems across a number of segments. In particular, the company operates in the life sciences, diagnostics, energy and medical devices markets.
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What's driving the Anteotech share price?
The Anteotech share price is soaring today after the company released news of an important agreement with Operon. To this point, the biotech has finalised and signed a manufacturing contract for its COVID-19 antigen rapid test (ART), EuGeni, with the Spanish company.
The announcement comes after the successful completion of the technology transfer in March, which also saw the Anteotech share price jump by 15%.
Moreover, under the terms of the agreement, the companies have agreed to an exclusivity period of three years. During the period, Operon has a manufacturing capacity of 8 million complete tests per annum, giving Anteotech the capacity to fulfil the expected demand for EuGeni.
Regulatory compliance
Anteotech is now a legal manufacturer of a medical device which means the company's quality management system (QMS) needs to be compliant with both domestic and international regulatory authorities. As such, over the next 12 months, Anteotech will submit a range of tests to the TGA, FDA and Europe's equivalents.
Furthermore, due to the emerging need to enhance its QMS, the company will also bring forward its Eugeni tests by 3 months, while delaying its TGA submission by the same time frame. This will allow findings from the trial to be included in the TGA submission. To this point, the deferral will not hinder the current roll-out and distribution of the ART internationally.
As stated by the company:
In fact, we believe the international markets provide a much stronger opportunity. To date, a high level of enquiries for the ART have been fielded from jurisdictions in which our CE Mark is accepted or where other regulatory approvals or emergency use authorisations are required.
About the Anteotech share price
The Anteotech share price has performed remarkably over the last 12 months. It's gained an astounding 1,400% as the company saw interest in its products increase during the global pandemic.
The company's validation-of-saliva samples for its rapid test are currently underway. Pending analysis and results of the saliva samples, Anteotech remains on track to provide an update in June 2021.
