Sales of Viraspec Covid-19 tests are being resumed
AegirBio is happy to announce that after successfully addressing all non-conformities raised during the unannounced audit of our subcontractor in November 2022, sales of the Viraspec Covid-19 test for both home and professional use can now begin again.
The ViraSpec Covid 19 antigen test was stopped on 10 November 2022 after an unannounced inspection at one of the Company's key suppliers. The identified non-conformities have now been addressed by the subcontractor wherefor the notified body has lifted the sales ban for the home test. The test for professional use, which the Company itself sales stopped pending the outcome of the notified body's review, is at the same time made available to the market. ViraSpec Covid 19 test is now available for the home testing market and for professional use.
This disclosure contains information that AegirBio is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 28-02-2023 10:57 CET.
For further information, please contact:
ir@aegirbio.com
About Aegirbio
Aegirbio is a Swedish diagnostics company offering 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 and suboptimal clinical outcomes.
The Company's tests for optimal dosing of biological drugs will be focused on neurological disorders, autoimmune diseases and cancer. In the first quarter of 2020, Aegirbio initiated sales in the U.S. of the MoNATor test for the drug Tysabri, which is used for treatment of the neurological disorder Multiple Sclerosis (MS). Aegirbio’s goal is to launch a total of four tests before 2023. Diagnostics will be offered through laboratory testing as well as in the form of a P.O.C. (Point of Care) test for use in hospitals and health centres. The plan further includes P.O.N. (Point of Need) tests for use at home.
For more information, see Aegirbio's website www.aegirbio.com
The company's Certified Adviser is Eminova Fondkomission AB | 08-684 211 00 | info@eminova.se
This information is such information that Aegirbio AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the above contact person, for publication on August 27, 2020 at 18:10 CET.