The member of the Basque Health Cluster located in Zamudio has made a significant investment in the equipment necessary to scale up this newly developed product.
Since January, BIOLAN has had a new developed and validated product with excellent sensitivity (96%) and specificity (93%) results and meeting all the necessary requirements for going to market, such as CE mark certification, and manufacturing and exportation licence from the Spanish Agency for Medicines and Medical Devices (AEMPS)
The COVID-19 IgG/IgM Rapid Test Cassette (in Spanish), developed by BIOLAN HEALTH, the company’s health division, allows the detection of SARS-CoV-2 antibodies in people who are, or have been, infected by the COVID-19 virus in under ten minutes and at a low cost.
Video in Spanish:
The differentiating factor of this new test is that it can detect antibodies with the potential to neutralise SARA-CoV-2 as they are directed against the RBD (Receptor Binding Domain) of the virus’s spicule matrix protein, the one responsible for its entry into the cells.
In this regard, the vaccines currently being distributed contain the mRNA of this protein, the idea being to trigger the patient’s immune system into producing this kind of neutralising antibodies. This kind of test is useful for the identification of people carrying SARS-CoV-2 antibodies and are “potentially immune” in order to conduct epidemiological studies to find out more about the incident rate and the spread of the virus, as well as acting as a useful tool for assessing the efficacy of vaccines.
BIOLAN has decided to take a chance on the large-scale manufacturing of this product line based on lateral flow technology, by setting up a new production facility with the industrial equipment necessary to make 30,000 tests per day. This move has been supported by the Basque Government through SPRI. This on-site production capacity will allow BIOLAN to ensure the test goes to market; there is starting to be interest among potential distributors such as pharmaceutical companies, as well as international markets such as Chile, Ecuador and Morocco, where authorised import licences have started to be processed.
With this initiative, BIOLAN is making its own contribution in know-how and infrastructure to help in the management of the COVID-19 pandemic and the reactivation of the Spanish economy.