Color secures FDA EUA status for Covid 19 testing technology
Color, a provider of distributed healthcare and clinical testing services, has secured an emergency use authorisation from the US Food and Drug Administration (FDA) for its Loop-mediated isothermal amplification (LAMP) technology to use in Covid-19 testing.
LAMP is a molecular testing technology designed to offer Covid-19 test results with precise equivalent to the current gold standard method reverse transcription polymerase chain reaction (RT-PCR),
It is a method of amplifying segments of the viral genome within Covid-19 test samples for the detection of the presence of the virus.
LAMP occurs at a consistent temperature compared to the RT-PCR that amplifies viral genome segments through a method that needs multiple cycles of heating and cooling.
LAMP testing is said to be completed 50% faster than RT-PCR testing for Covid-19
LAMP testing, which is said to be completed 50% faster than RT-PCR testing for Covid-19, requires a different set of chemical reagents.
According to the company, the LAMP technology is already used for the rapid diagnosis of certain conditions such as Zika and dengue fever.
Color has also entered into scientific collaborations with the Broad Institute of MIT and Harvard and Weill Cornell Medicine for COVID-19 testing and technology development.
Color already established a partnership with San Francisco Mayor London Breed’s CityTestSF programme to conduct Covid-19 tests for all essential workers in the city.
Color CEO Othman Laraki said: “When we started mobilizing Color around the COVID-19 crisis 8 weeks ago, we knew that the country needed a technology-driven solution to scale its testing efforts.
“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.”
Recently, Everlywell has secured FDA EUA status for its Covid-19 Test Home Collection Kit, which can be used with certain authorised tests.