Applied BioCode has secured an emergency use authorisation for its SARS-CoV-2 Assay to better detect the people affected with the Covid-19 disease.
The BioCode SARS-CoV-2 Assay, which is a CLIA high-complexity multiplex nucleic acid assay, will help in the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples.
The samples can be collected from nasopharyngeal swabs, nasal swabs, oropharyngeal swabs and bronchoalveolar lavage used by suspected individuals with Covid-19 with the support of their healthcare provider.
BioCode MDx-3000 system is used to run the multiplex nucleic acid assay
BioCode MDx-3000, an automated molecular diagnostic system, is used to run the high-complexity multiplex nucleic acid assay.
The BioCode SARS-CoV-2 Assay has the capacity to deliver up to 564 sample results in a day, helping to better meet Covid-19 testing requirements.
BioCode’s multiplex nucleic acid assay has been developed for the detection of two different regions of the SARS-CoV-2 virus N gene, which are also used by the CDC EUA assay.
According to the company, the assay can be run as an independent assay or in parallel with the firm’s FDA-cleared BioCode Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.
Applied BioCode president Dr Winston Ho said: “We are extremely pleased to provide our BioCode SARS-CoV-2 Assay with the high throughput automated MDx-3000 system to help with the fight against the COVID-19 pandemic.”
“Our automated assays can provide CLIA high complexity laboratories with the capability to perform high throughput, efficient testing to meet testing needs. Furthermore, our multiplex BioCode Respiratory Pathogen Panel offers comprehensive tests combined with flexible ordering and reporting capabilities.”
In June 2019, Applied BioCode announced that the FDA granted 510(k) clearance for the use of Roche MagNA Pure 96 Extraction System with its BioCode MDx-3000 and Gastrointestinal Pathogen Panel (GPP).
Applied BioCode is engaged in the designing, development and commercialisation of multiplex testing products.
