Aegirbio’s saliva test approved by Thailand’s FDA

As the only test based on saliva detection, Aegirbio's COVID-19 test has obtained marketing authorization from the Thai equivalent of the US FDA for introduction on the Thai market. The approval is for professional use, but we expect the test to be approved for home use as well in the near future.

The authorization opens up a market where Thailand and its neighbouring countries represent a catchment of more than 600 million inhabitants. The Company is already in contact with and making sales to a number of these countries and their respective authorities. Aegirbio is well prepared, and has, as previously announced, scaled up production to supply up to 9 million tests on a monthly basis. The Company is currently exploring ways to increase the rate of production even further. The spread of infection is high in the region, and the Government of Thailand has decided that Viraspec shall be an active part of the contact tracing effort. Our projection is that the need will remain at the same high level at least throughout 2022.

“That we succeeded in receiving authorization in Asia in such a short time is a big deal; the Thai FDA imposes just as strict requirements as the rest of the world, and this is evidence that our tests are up to the highest standards. It feels great to be able to contribute to the fight against the pandemic. The forecast for the Asian countries extends over a long time scope, and our products will be needed to suppress the spread. Our partner NowMed Sweden, in tandem with JP World Medical with responsibility for the Far East, have done a remarkable job thus far, and we have entrusted them 15 additional countries beyond Thailand. We are now looking forward to a similar development in those countries,” says Martin Linde, CEO of Aegirbio.

“We are proud to bring the first saliva-based test for COVID-19 from Europe to the Thai market. The rapid approval by the FDA is proof in itself. I am very pleased and proud of the opportunities that the authorization provides and look forward to introducing Viraspec in all our countries of operation,” says Jacky Ong, CEO of JP World Medical.

This information is information that AegirBio is obliged to make public pursuant to the EU Market Abuse Regulation (Regulation (EU) No 596/2014). The information was submitted for publication, through the agency of the contact person set out above, at 12:51 CET on 2021-08-06.

for more information please contact:

Anders Ingvarsson, SO Aegirbio AB
E-mail: aingvarsson@aegirbio.com
Telephone: +46 706 791 878

Martin Linde, CEO Aegirbio AB
E-mail: mlinde@aegirbio.com
Telephone: +46 706 730 968

Aegirbio is a Swedish diagnostics company established to offer tests to monitor and optimize the dosing of biological drugs by means of a unique, patented technology platform. Biological therapies is the fastest growing segment of the pharmaceutical industry; a quarter of all drugs are projected to be biological in 2020. At the same time, drug concentrations vary tremendously (up to 100 times) in patients that receive biological drugs in standard doses.

The result of this one size fits all-approach is that patients with low drug concentrations do not respond to treatment, while excessive drug concentrations increase the risk of adverse effects in others. The uncertainty surrounding dosing results in overdosing or underdosing in about 55 percent of the cases, which causes unnecessary costs, suboptimal clinical outcomes, and a higher proportion of patients suffering severe side effects.

The Company has completed acquisitions that ensure long-term access to key technologies and open up new application areas. Through these acquisitions, Aegirbio, rooted in laboratory testing, have in a short period of time added technologies and skills to the Company to make headway towards becoming the multidiagnostic company it has set out to be.

Aegirbio is now building its operations around technologies for

• Rapid testing for indicative and quick results
• Point of Need, quantitative home tests for chronic diseases
• Point of Care, quantitative point-of-care tests for routine controls in clinics and health centres
• Laboratory tests for monitoring patients treated with biological drugs.

The acquisitions provide the Company the means to develop new diagnostics to enable people to monitor their own health issues. In addition to bringing innovative diagnostic technology to market, the Company’s ambition in that regard is to make diagnostics more accurate, easier to use and with precise and easily transferable results. For more information, please visit Aegirbio’s website, www.aegirbio.com

Certified adviser for the company is Eminova Fondkommission AB  | +468-684 211 00 |info@eminova.se