Compliance with New York State Winter COVID-19 Plan Drives Demand for Applied DNA’s Pooled Surveillance Testing Program - Seite 3

safeCircle – A Customized Approach

ADCL designs customized proactive surveillance programs for schools and other organizations based on their risk tolerance and budget, ranging from testing every individual once weekly to every day or other audit plan appropriate to the client’s population profile. This allows administrators to respond to risk elevations wherein a subset of the population can be serially tested at a higher frequency. Surveillance testing is done anonymously with administrators at the school or other organization tracking the identity of the encoded samples. No protected health information is transferred, no prescription is required, and aggregate de-identified results are reported only to the school or other organization. In the event of a positive pool, safeCircle scientists analyze the individual samples to confirm the presence of COVID-19 RNA. Infected member(s) of the pool are then directed by their program coordinator for the next steps, which may include consultation with their healthcare provider referral to a local certified reference laboratory partner for diagnostic confirmatory testing with an authorized RT-PCR test.

Footnotes:

¹ https://www.governor.ny.gov/news/governor-cuomo-announces-winter-plan- ...

About safeCircle

ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the Linea^TM COVID-19 Assay Kit

The Linea COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.