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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 percent faster and with different supply requirements. That means more […]

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 percent 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 int eh 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 ben working with the city of San Francisco on testing protocol for its essential and frontline 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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