FDA Gives EUA for At-Home COVID-19 Testing

July 27, 2020

The federal agency gives approval for technology company’s test that supports unmonitored testing.

The company Color announced it has received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to offer coronavirus 2019 (COVID-19) testing without clinical monitoring.

The Color test now supports unmonitored testing both at-home as well as onsite for congregate settings.

This EUA amendment makes it possible to address two key bottlenecks that still limit access to testing: the lack of sufficient clinical staffing to collect samples and the shortage of sample collection kits.

"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," Color CEO Othman Laraki said.

This update to Color's testing process is part of the company's strategy to further increase access to COVID-19 testing by addressing technical, supply chain and logistical bottlenecks in the testing process. The EUA is designed for large population and public health initiatives rather than consumer-initiated testing.

This EUA is an amendment to Color's original filing, which granted the company the first authorization to use a LAMP process in a centralized laboratory for COVID-19 testing. Color's original EUA was designed to address supply chain and turnaround time limitations.

LAMP is a molecular testing technology that delivers COVID-19 test results with accuracy equivalent to the current gold standard method, reverse transcription polymerase chain reaction (RT-PCR), but lends itself more readily to high-throughput automation and rapid lab scaleup. LAMP is a method of amplifying segments of viral genome within COVID-19 test samples to detect the presence of the virus.

Color's COVID-19 unmonitored testing kit is permitted for use without direct clinical monitoring. This helps to reduce the number of health care workers involved. The process makes it possible for patients to utilize Color's test at home and return a sample by mail, as well as on-site as part of a test collection process.

The latter makes it possible for Color's test to be used to support onsite testing in critical public health contexts, such as community testing sites, places of employment, and universities.

Whereas, other testing options either require saliva or nasal samples with a stabilizing solution such as saline, Color's unmonitored test kit uses a dry nasal swab.

The dry nasal swab format consists of a spun polyester swab and tube—both of which are in abundant supply. This collection kit is also the least expensive available—costing less than $1.

More expensive saliva collection tubes can typically cost $5-$10. Moreover, the lack of viral transport media in the tube (saline or other stabilizing solution) resolves usability issues, like spillage and safety, which necessitate more careful handling and complex kit design.

The company has also found that dry nasal swabs provide a more consistent sensitivity and stability profile, representing a favorable set of tradeoffs for unmonitored collection and mail-based handling.

"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," Alicia Zhou, Chief Science Officer, Color said.

Color supplies the majority of the testing for San Francisco and other major public health test initiatives, with an average 24-hour turnaround time for test results.