Applied DNA Secures Amendment to Master Services Agreement and Fourth Blanket Purchase Order from Linea COVID-19 Assay Kit Customer

Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that it secured an amendment to a Master Services Agreement (MSA) with an existing customer of its Linea COVID-19 Assay Kit (the “Assay Kit”). The amendment doubles the undisclosed maximal value of the MSA to ensure the customer’s continuing access to the Assay Kit for the customer’s pooled COVID-19 surveillance testing program. Concurrently, the Company announced the receipt of a purchase order for its Assay Kits and consumables to enable the customer to conduct 16,000 tests to be used for recurring surveillance testing and support the customer’s in-person graduation ceremonies in May 2021.

“The increase in MSA value and our receipt of a fourth purchase order speaks to the value our customer places on their continuing ability to proactively monitor their populations for SARS-CoV-2 spread via cost-effective, rapid turnaround time-to-results surveillance testing that is powered by our Assay Kit,” said Dr. James A. Hayward. “As society reopens thanks in large part due to growing vaccine availability, and people increasingly coming together, the need to monitor and manage virus spread is especially critical in light of the growing threat posed by coronavirus variants. We are immensely proud to continue to support our customers as the impact of increased vaccination alters the pandemic equilibrium.”

About the Linea COVID-19 Assay Kit and Pooled Surveillance Testing

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.