FDA grants EUA for Color’s Covid-19 testing technology
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Color to use its Loop-mediated isothermal amplification (LAMP) technology for Covid-19 testing.
The technology helps detect the presence of the virus by amplifying segments of viral genome within Covid-19 test samples.
Furthermore, the molecular testing technology delivers test results with accuracy equivalent to reverse transcription polymerase chain reaction (RT-PCR), which is the current gold standard method.
Compared to RT-PCR testing, LAMP is 50% faster. It also requires a different set of chemical reagents, avoiding supply chain issues that have created backlogs for other test providers.
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Additionally, LAMP technology lends itself more readily to high-throughput automation and rapid lab scale-up.
Color is publishing its protocol for LAMP for other labs to replicate. The company noted that the technology has been used for rapid diagnosis of certain conditions such as Zika and dengue fever.
Color CEO Othman Laraki said: “When we started mobilising Color around the Covid-19 crisis eight weeks ago, we knew that the country needed a technology-driven solution to scale its testing efforts.
Loading ...“We knew that addressing our national testing shortage would require a dramatically more scalable approach to lab design, which is what led us to LAMP. Moreover, in addition to testing capacity, reopening the country and bringing people back to work safely would require a technology-driven solution to make testing truly accessible.”
The company has also collaborated with the Broad Institute of MIT and Harvard and Weill Cornell Medicine for Covid-19 testing and technology development.
Color has published a protocol for the US employers for reducing the risk of Covid-19 among their workforce as they prepare to return to work after the lockdown.
The two-phased population screening process proposed by Color suggests a monthly and weekly testing based on population size and risk to mitigate potential outbreaks.
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