Color Receives Emergency Use Authorization for COVID-19 Testing Technology; Releases Return to Work Protocol

SAN FRANCISCO, May 20, 2020 /PRNewswire/ -- Today, Color announced it has received an emergency use authorization from the U.S. Food and Drug Administration to use LAMP technology for COVID-19 testing. Color is publishing its protocol for LAMP, or Loop-mediated isothermal amplification, for other labs to replicate. Color has also posted a protocol for employers to offer accessible testing in the workplace, and is designed to reduce the risk that employers are forced to shut back down due to outbreaks after reopening the workplace.

"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," said Color CEO Othman Laraki. "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 LAMP Protocol
LAMP is a molecular testing technology that delivers COVID-19 test results with accuracy equivalent to the current gold standard method, reverse transcription polymerase chain reaction (RT-PCR), but lends itself more readily to high-throughput automation and rapid lab scaleup. LAMP is a method of amplifying segments of viral genome within COVID-19 test samples to detect the presence of the virus.

Unlike RT-PCR, which amplifies viral genome segments through a method that requires multiple cycles of heating and cooling, LAMP takes place at a consistent temperature. Because of this, many of the steps in LAMP can be automated, cutting down the time it takes to process samples. LAMP testing can happen 50 percent faster than RT-PCR testing for COVID-19 and requires a different set of chemical reagents, meaning that Color can avoid supply chain issues that have created backlogs for other test providers. LAMP technology has been used for rapid diagnosis of certain conditions, like Zika and dengue fever, at the point of care. Color has also developed scientific collaborations with the Broad Institute of MIT and Harvard and Weill Cornell Medicine for COVID-19 testing and technology development.

"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 Eric Lander, President of the Broad Institute of MIT and Harvard. "I'm impressed by Color's combination of scientific rigor, efficient technology and commitment to help address the COVID-19 crisis."

A Protocol For America to Return to Work
As America returns to work, employers and city leaders' greatest challenge will be to ensure they are not forced to shut back down due to COVID-19 outbreaks. Workplace safety measures such as shift changes, sanitation and social distancing will help reduce the rate of infection. However, given the rate of asymptomatic transmission, employers will need to jointly implement a proactive testing strategy to ensure that individual cases of COVID-19 do not turn into outbreaks that force a subsequent withdrawal of a workforce.

In conjunction with the lab protocols, Color is today sharing a data-driven protocol that is designed to reduce the risk that employers across the U.S. are forced to shut down due to COVID-19 outbreaks within their workforce.

In addition to the now-standard testing of symptomatic and exposed individuals, the protocol published by Color puts forward a two-phased population screening process. In the first phase, when there is no known case or outbreak within a population, monthly testing (adjustments made based on population size and risk) targets a 98% probability of catching cases before an outbreak exceeds 1% of a population. If and when one or more cases are found, the protocol switches to a second active control phase, with an active full-workforce weekly testing cadence until the potential outbreak has been mitigated.

Building on a History of Serving Distributed Populations
Color leveraged its deep expertise in population health and distributed clinical testing to improve COVID-19 testing since the pandemic spread to the U.S. 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 and could serve as a model for employers and public officials across the country.

As of mid-May, Color's CityTestSF testing sites have collected more than 14,000 samples and are among the highest-capacity in the country. So far, 77 percent of people who have been tested are essential workers such as healthcare employees, firefighters, members of the police force and others who are crucial to the economic health of the city.

Color has leveraged its infrastructure to support return to work efforts by public and private employers across the country, including the Morehouse School of Medicine in Atlanta, Ga. Morehouse is the first medical school established as a Historically Black College and University in the 20th century, to provide COVID-19 testing to all faculty and staff as part of its plan to return to campus.

"Color's Workforce Testing Program gives us the best tools available to ensure our teams' health and safety and to contribute to the effort of getting our country back to work," said Morehouse School of Medicine President and Dean Valerie Montgomery Rice, MD.

For the latest information on Color's efforts, visit https://www.color.com/covid.

About Color

Color is a leader in distributed healthcare and clinical testing. Color makes population-scale healthcare programs accessible, convenient, and cost-effective for everyone. Color works with health systems, employers, and national health initiatives around the world including the million-person All of Us Research Program by the National Institutes of Health. For more information about Color and its response to COVID-19, visit www.color.com.

SOURCE Color

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