Based on the totality of scientific evidence the FDA authorization has validated the Spectrum SDNA-1000’s effectiveness in diagnosing COVID-19 by serving as a successful, noninvasive means to collect, neutralize, stabilize, and transport testing samples post-collection at ambient temperatures for over 10 days with no degradation in sample efficacy. Additionally, the FDA states there is no adequate, approved or available alternative to the emergency use of this product.