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Color Receives FDA Emergency Use Authorization for COVID-19 Test Using Isothermal Amplification

This article has been updated with additional information about the nature of the EUA granted to Color.

NEW YORK – Color said on Wednesday that it has received US Food and Drug Administration Emergency Use Authorization to provide COVID-19 testing using loop-mediated isothermal amplification (LAMP) technology.

Color's lab is the only one authorized to run the test under the EUA but the firm has published the test method to help other labs implement it.

The Color SARS-CoV-2 LAMP Diagnostic Assay is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nares swabs, mid-turbinate nasal swabs, NP wash/aspirate or nasal aspirates, and bronchoalveolar lavage specimens collected from individuals suspected of having COVID-19 by a healthcare provider, according to the published protocol.

The assay includes a reverse transcription step followed by LAMP and uses three SARS-CoV-2-specific primer sets targeting the SARS-CoV-2 nucleocapsid gene (N), the envelope gene (E), and the ORF1a region. In addition, a fourth primer set that targets the human ribonuclease P (RNaseP) transcript is used as a positive human control.

Results of the test are interpreted by colorimetric readout. The Color assay was demonstrated to have a limit of detection of 0.75 copies of viral RNA per μl of primary sample and showed 100 percent positive and negative agreement for 543 patient samples with previous results from other laboratories.

Color said that the assay uses LAMP chemistry modified from New England Biolabs.

In general, the major advantage of LAMP-based testing is that it takes place at a consistent temperature, obviating the need for a thermal cycler and making it more suitable for high-throughput automation and scale-up.

In addition, Color on Wednesday published a protocol for employers to offer accessible testing in the workplace. The company also said that in partnership with San Francisco Mayor London Breed's CityTestSF program, Color has made COVID-19 tests available to all essential workers in the city. As of mid-May, Color's CityTestSF testing sites have collected more than 14,000 samples, the company said.

"When we started mobilizing Color around the COVID-19 crisis eight weeks ago, we knew that the country needed a technology-driven solution to scale its testing efforts," Color CEO Othman Laraki said in a statement. "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."