Genomic testing firm Color received an emergency authorization from the FDA for its scalable COVID-19 screening method, which differs from the standard PCR-based technologies widely used so far.
Employing the LAMP process, for loop-mediated isothermal amplification, the molecular test uses a consistent temperature to drive the replication of different segments of the novel coronavirus’s genome—establishing a positive signal without the multiple cycles of heating and cooling and extra hardware required for PCR.
According to Color, this method can be more easily automated in a high-throughput laboratory and is suited for broader population testing by providing results 50% faster while using different chemical reagents than those seen in short supply. LAMP has previously been used for point-of-care diagnosis of the Zika virus and dengue fever.
“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,” 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.”
To develop its tests for the pandemic, Color has been working with the Broad Institute of MIT and Harvard as well as Weill Cornell Medicine. The company is also publishing its LAMP protocol (PDF) for use by other laboratories.
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“Color’s work to demonstrate the quality and effectiveness of a LAMP-based approach for COVID-19 testing is an important step in the quest to make testing ubiquitous in the country,” said Broad Institute President Eric Lander.
The company also published a schema for workforce screening, spanning a two-phase process. It includes a baseline of monthly testing, with adjustments made according to risk factors, before upscaling to weekly testing in the event a flare-up of the infection is detected.