Color, a leading health technology company committed to advancing public health, received an emergency use authorization (EUA) from the U.S. Food and Drug Administration that enables CLIA-certified laboratories designated by Color to use its self-swab COVID-19 collection kit for public health. Using Color’s kit and process, individuals can collect their own samples at home or onsite at workplaces or other congregate settings without requiring healthcare professionals to supervise the sample collection process.
The EUA unlocks the potential for labs across the country to benefit from Color’s kit and builds on Color’s efforts to overcome bottlenecks in COVID-19 test sample collection. Now, organizations with a high-complexity, CLIA-certified lab can use Color’s kit to efficiently offer testing without burdening clinical teams or having to develop a full suite of testing services, such as scheduling, test kit, patient workflows, or test result return to patients, clinicians and public health authorities.
This authorization by the FDA combines several developments by Color that, in concert, are designed to substantially increase cost-effective and convenient access to COVID-19 testing. First, this authorization builds on Color’s first authorization based on work by the Gates Foundation to demonstrate that dry anterior nasal swabs are an effective collection method for COVID-19 samples. The use of dry swabs overcomes supply chain bottlenecks, while providing a collection method that is safe and appropriate for at-home use. Second, in addition to being authorized for at-home use, Color’s collection method is approved for self-administered on-site collection. For example, some of the largest university testing programs in the country at institutions utilize Color’s process to offer testing to students and staff. Third, with this latest authorization, Color is now able to partner with qualified labs to enable them to offer the Color process to their populations.
“Deploying large-scale COVID-19 testing programs requires an integrated end-to-end solution. The effectiveness of a program is defined by its weakest link – or bottleneck, which is often found in the sample collection process. Reliance solely on in-person experiences with clinical staffing creates both bottlenecks and inconvenience for participants,” said Color CEO Othman Laraki. “We have built an end to end process that has demonstrated its effectiveness by powering some of the largest and most efficient testing programs in the country. With Color’s new FDA EUA, we can now work with scaled labs across the country to enable them to benefit from this process and make their testing capacity conveniently and cost-effectively accessible.”
Since the COVID-19 pandemic started, Color’s focus has been to develop technologies and processes to overcome bottlenecks that impede widespread testing. Innovations that Color has introduced include:
– Expanded laboratory capacity by introducing automation at its lab wherever possible. Now, its high-throughput lab in Burlingame, California, processes tens of thousands of samples per day.
– Boosted laboratory efficiency through an RNA amplification method called LAMP, which processes samples up to 50% faster than RT-PCR, the typical method used for COVID-19 testing.
– Validated unmonitored self-collection of COVID-19 samples using dry swabs, allowing individuals to collect their own samples without the presence of a healthcare provider. The use of dry swabs has established a secure supply chain for all components of the kit.
– Optimized scheduling and return of results by building an easy-to-use software tool that makes high-quality, fast-turnaround SARS-CoV-2 diagnostic testing available for large populations. Across its COVID-19 testing programs, Color returns results, on average, within 48 hours.
Color’s self-swab kit is already being used by universities, public health institutions, and employers to carry out frequent testing for large COVID-19 testing programs across the country
Organizations looking to partner with Color can contact the company here.
“Our kit brings a new resource to institutions looking to scale COVID-19 testing for public health,” said Color Chief Science Officer Alicia Zhou. “The fact that any large qualified lab can apply to use our self-swab kit is another important step in our mission to improve equitable access to testing.”
Color has delivered fast, convenient, and high-quality testing through partnerships with public health and government testing programs, including San Francisco’s successful CityTestSF program, Alameda County Health Services and federally qualified health centers in Alameda County, Marin County and others.
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.