NEW YORK — Applied DNA Sciences said on Tuesday that it has partnered with Stony Brook University Hospital to validate the company's SARS-CoV-2 diagnostic.
Called LineaCOVID-19, the test is designed to detect and quantify SARS-CoV-2 nucleic acid. Under the terms of the deal, Applied DNA will permanently place robotic and diagnostic equipment at Stony Brook University Hospital to enable validation of the test at throughputs of over 500 patient samples per eight-hour shift. Results of the validation work will be used to support an Emergency Use Authorization (EUA) application for the test that will be filed with the US Food and Drug Administration before the end of the month.
Applied DNA will also sell diagnostic kits to the hospital pending the receipt of an EUA.
During internal testing, "we aligned 74 variants of the [SARS-CoV-2] S gene sequence currently available in the [National Center for Biotechnology Information] database," Applied DNA President and CEO James Hayward said in a statement. "This gene is highly conserved, being close to 100 percent identical across variants, meaning that detection via our diagnostic kit should be consistent even against the capacity for this virus to mutate."
The Stony Brook, New York-based company said it intends to market a basic version of the test designed for high-volume labs that can provide some of the required bulk ingredients and a premium test that will include all necessary materials.
Applied DNA added that it is also working with vendors to provide a fully integrated monobloc platform that will allow certified testing organizations to install turnkey operations in a single order.
Earlier this year, Applied DNA subsidiary LineaRx expanded an agreement with Italy's Takis Biotech to include preclinical development of a linear DNA vaccine against 2019-nCoV.