Health technology company Color has secured emergency use authorisation (EUA) from the US Food and Drug Administration for its self-swab Covid-19 collection kit.
The EUA status enables to use Color’s self-collection kit by CLIA-certified laboratories to increase Covid-19 testing for public health.
Individuals can collect their own samples at home or onsite at workplaces or other congregate settings by using Color’s kit and process, thereby helping to avoid the supervision of healthcare professionals in the sample collection process.
Color’s kit will allow organisations with a high-complexity CLIA-certified lab to efficiently deliver testing without stressing clinical teams.
Color’s Covid-19 kit helps to avoid the development of a full suite of testing services
The kit also helps to avoid the designing of a full suite of testing services such as scheduling, test kit, patient workflows, or test results return to patients, clinicians and public health authorities.
According to the company, the EUA status builds on its first authorisation based on work by the Gates Foundation to show that dry anterior nasal swabs are an effective collection method for Covid-19 samples.
The collection method offered by Color also secured approval for self-administered on-site collection. The latest authorisation will also allow Color to provide its process to qualified labs for benefitting the populations.
Color already delivered its kits to universities, public health institutions, and employers to conduct frequent testing for large Covi-19 testing programmes across the country.
Color CEO Othman Laraki said: “We have built an end to end process that has demonstrated its effectiveness by powering some of the largest and most efficient testing programmes in the country.
“With Color’s new FDA EUA, we can now work with scaled labs across the country to enable them to benefit from this process and make their testing capacity conveniently and cost-effectively accessible.”
In September this year, DetectaChem secured FDA EUA status for its MobileDetect Bio (MD-Bio) BCC19 Covid-19 test kit.
