The Basque SME located in Zamudio has invested heavily to equip itself with the equipment that will allow it to scale up the newly developed product.
Since January, BIOLAN has had a new product developed and validated with excellent results in terms of sensitivity (96%) and specificity (93%) and with all the necessary requirements for its commercialisation, such as CE marking certification, manufacturing and export licences from the Spanish Agency for Medicines and Medical Devices (AEMPS).
The serological test COVID-19 IgG/IgM Rapid Test Cassette, developed by BIOLAN HEALTH, allows the detection of antibodies against SARS-CoV-2 in people who are or have been infected by the virus that causes COVID-19 in less than ten minutes and at low cost.
The differentiating element of this new test is that it can detect antibodies that have the potential to neutralise SARS-CoV-2 because they are directed against the RBD (Receptor Binding Domain) of the spicular (S) protein of the virus, which is responsible for its entry into the cell.
In this sense, the vaccines that are currently administered contain the mRNA of this spicular protein, since the aim of these vaccines is for the patient’s immune system to generate this type of neutralising antibodies. This type of test is useful for identifying people who have antibodies to SARS-CoV-2 and are “potentially” immune, for carrying out epidemiological studies to better understand the incidence and spread of the virus, and can also be a useful tool for evaluating the effectiveness of vaccines.
BIOLAN has decided to commit to the large-scale manufacture of this product line based on lateral flow technology, for which it has set up a new production facility with industrial equipment with the capacity to manufacture 30,000 tests per day, with the support of the Basque Government, through SPRI. Its own production capacity will allow BIOLAN to ensure the commercialisation of the test, which is beginning to generate interest among potential distributors such as pharmaceutical companies and also in international markets such as Chile, Ecuador and Morocco, among others, where the processing of authorised import licences has begun.
With this commitment, BIOLAN is making its particular contribution in terms of knowledge and infrastructures to help in the management of the pandemic derived from COVID-19 and in the economic reactivation of the country.