The Covid-19 testing without clinical monitoring can be carried out both at home, as well as onsite for congregate settings
Health technology company Color has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its unmonitored Covid-19 testing technology.
The Covid-19 testing without clinical monitoring can be carried out both at home, as well as onsite for congregate settings.
Color’s new testing process is part of the firm’s strategy to further enhance access to Covid-19 testing by solving the technical, supply chain and logistical issues in the testing process.
Color CEO Othman Laraki said: “Covid-19 testing access is difficult because it is not a single problem – it’s an array of distinct, but connected, problems. The country needs a set of holistic solutions that solve each part of the chain of testing bottlenecks, and that is what we strive for at Color.”
“This EUA enables us to dramatically increase the availability and accessibility of testing in high-risk, high-exposure contexts, which we believe is essential to supporting a safe re-opening of our society.”
According to the company, the EUA is an amendment to Color’s original filing, which granted the firm the first authorisation to use a LAMP process in a centralised laboratory for Covid-19 testing.
The Covid-19 unmonitored testing kit cabn be used at home
Color’s Covid-19 unmonitored testing kit will help reduce the number of healthcare workers involved, as well as enables to use the test at home and return a sample by mail and on-site as part of a test collection process.
The dry nasal swab will be provided in the Color’s unmonitored test kit, while other unmonitored Covid-19 testing options either need costly saliva samples or nasal samples with a stabilising solution such as saline.
The dry nasal swab format includes a spun polyester swab and tube, which are widely available.
Color chief science officer Alicia Zhou said: “The EUA to use dry swabs for unmonitored testing sets Color up to continue to scale the capacity at our lab, provide relief to healthcare workers who are spending valuable time collecting samples, and expand access to fast, accurate testing for high-risk populations, essential workforces and people in our communities.”
Recently, Quest Diagnostics secured FDA EUA status for sample pooling in the diagnostic testing of Covid-19.