The studies were conducted at Linköping University and the hospital of Pescara, Italy. In the studies, the saliva test was compared with PCR – the current gold standard for detection of virus. Aegirbio's test could detect the presence of virus in every PCR-positive sample, and every sample identified as negative by PCR, i.e., without virus, was negative with the Aegirbio test as well.
"Together with qualified partners, we have carried out two studies outside our laboratory to compare our rapid saliva test with PCR. The fact that our results are totally consistent with the PCR results and that our test is capable of detecting very low virus concentrations without false positives make us very proud. This clearly shows that our product is working, and we will now ramp up production to finalize the preparations for a market launch during Q1 next year," says Mohamad Takwa, COO of Aegirbio AB.
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, please visit Aegirbio’s website, www.aegirbio.com
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