Research & Development
Applied DNA Signs Master Services Agreement with Stony Brook University Hospital for COVID-19 Diagnostic Assay Kit and Automated Systems, Receives Initial Purchase Order
29 September 2020 - - US-based DNA manufacturing specialist Applied DNA Sciences, Inc. (NASDAQ: APDN) has signed a master services agreement with Stony Brook University Hospital, the largest academic medical center on Long Island, N.Y., the company said.

Under the terms of the one-year MSA, Applied DNA will supply its EUA authorized Linea COVID-19 Assay Kit to SBUH on an as-needed basis.

Concurrently, the company announced the receipt of an initial purchase order under the MSA.

Terms of the MSA and initial purchase order were not disclosed.

Under the MSA, the company designed and implemented an automated, high-throughput COVID-19 testing workflow in the SBUH clinical lab.

The implemented high-throughput testing workflow is a fully integrated offering that includes equipment, software, and services leased through the company, including robotic RNA extraction, robotic sample preparation, and RT-PCR custom software and interfaces with laboratory information systems.

The testing workflow offers the SBUH clinical lab enhanced operational flexibility and an enhanced testing capacity with the Assay Kit.

The company is willing to offer similar equipment arrangements to other diagnostic labs looking for high sensitivity, high throughput testing solutions for COVID-19.

COVID-19 diagnostic testing with the Assay Kit can be performed on a variety of PCR and nucleic acid extraction platforms using samples obtained from nasopharyngeal swabs or less intrusive anterior nasal swabs.

Recent changes in the laws governing Laboratory Developed Tests allow certified laboratories to use the kit to tailor assays within a single certified laboratory for the device platforms they already have on hand. Saliva sampling and pooled testing methods for the Assay Kit have been developed by the company for scaled Surveillance Testing within communities and organisations.

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

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 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 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.
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