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Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced the receipt of a purchase order for its Linea™ COVID-19 Assay Kit (the “Assay Kit”) and consumables to conduct 10,000 tests under a Master Services Agreement with an existing customer. The Company expects to deliver most of the purchase order in the current fiscal quarter ending March 31, 2021 with the balance to be delivered in the following fiscal quarter. This blanket purchase order represents the third such order from the customer for the purpose of conducting pooled COVID-19 surveillance testing.
In January 2021, the U.S. Food and Drug Administration published a safety communication that identified the Company’s Assay Kit as one of a limited number of molecular diagnostics marketed under the FDA’s Emergency Use Authorization (EUA) that are potentially able to discriminate certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). The Company believes that its Assay Kit can give public health officials, diagnostic laboratories, and pooled surveillance testing customers a fast and cost-efficient tool – whether through diagnostic or pooled surveillance testing – with which to potentially screen for and track B.1.1.7 spread that is made more challenging by the variant’s apparent transmission advantage.
“This latest order is an endorsement of the enduring utility of our Assay Kit in a testing environment simultaneously experiencing rising vaccination rates and growing COVID-19 variants spread with their potential to escape vaccine-induced immunity,” stated Dr. James A. Hayward, president and CEO, Applied DNA. “The use of our Assay Kit as a diagnostic test or in a pooled surveillance testing modality, as is the case with this customer and our safeCircle™ service, serves as an effective, complementary layer of protection as reopenings bring into close contact both vaccinated and unvaccinated populations at a time when community transmission remains a leading cause of virus spread. With fully 51% of new infections in New York City being attributed to variants1 (B.1.1.7 and New York City) and a recent study from the U.K. assigning a potentially higher mortality rate to the U.K. variant2, we believe that our Assay Kit and safeCircle service are compelling virus mitigation offerings in the fight against COVID-19 and the growing threat of certain variants.”