Color receives FDA authorization for COVID-19 test tech that speeds up results

Color receives FDA authorization for COVID-19 test tech that speeds up results

Color has received an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for use of a testing method for detecting COVID-19 that provides accuracy it says is on par with currently approved best-in-class methods, but that can also produce results around 50% faster and with different supply requirements. That means more tests, done more quickly, and without the same supply chain bottlenecks — and Color is making its protocol for the tests available publicly for other labs.

In March, Color announced its intent to launch a high-throughput COVID-19 testing lab, and LAMP provides a big part of improving turnaround time since many parts of the testing process can be automated — which isn’t possible with the existing RT-PCR tests. Both these tests are molecular, meaning they detect presence of the actual virus in the body, and LAMP has been used previously as a technique for testing for Zika and dengue fever.

In addition to making the LAMP testing protocol it developed freely available to other labs for their own implementation, Color is offering a protocol it designed based on available data for population-based screening and regular testing in order to facilitate back-to-work efforts, while also keeping workforces as safe as possible. The protocol details two phases, including one where there hasn’t been any confirmed case in a workplace, but alert remains high, and a second where there’s been a number of confirmed cases and containment is necessary.

Color has been working with the city of San Francisco on testing protocosl for its essential and front-line workforce, and it has also been working with MIT’s Broad Institute and Harvard and Weill Cornell Medicine in development of its tech. These combined efforts put it in a good position to share its learnings with others as more in the U.S. seek to stage re-openings while continuing to contain the spread of the virus.

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