7 April 2021 - - US-based DNA manufacturing company Applied DNA Sciences, Inc. (NASDAQ: APDN) and New York, US-based hospital operator Northwell Health have entered into a pro bono Material Transfer Agreement that establishes a real-time surveillance program for the tracking and identification of SARS-CoV-2 mutations and variants of concern in Northwell's COVID-positive specimens, the companies said.

Under the program, de-identified positive COVID-19 specimens supplied by Northwell are being screened for SARS-CoV-2 mutations found in currently known VoCs using Applied DNA's Linea COVID-19 Assay Kit and Selective Genomic Surveillance (SGS) Mutation Panel.

The Program currently has the analysis of over 2,000 samples underway, with early results from approximately 360 samples showing that approximately 80% of specimens tested on the company's qPCR assays contain one or more mutations.

Data generated from the Program will enable Northwell to make more efficient use of costly and time-consuming next-generation sequencing necessary to conclusively identify specific VoCs and their subsequent descendants.

Aggregate data from the Program that could influence vaccine or booster design, antibody therapies, or drug development may be monetized by either party under a revenue-share structure. The Program also provides valuable SARS-CoV-2 mutation data to support the continued validation of the company's SGS Mutation Panel.

An Applied DNA-authored white paper on SGS of SARS-CoV-2 will be available for publication shortly.

The combination of the SGS Mutation Panel and Assay Kit in a prescreening modality is offered for sale to healthcare institutions, healthcare systems, and governmental agencies seeking a cost-effective platform to better understand how, where, and why COVID-19 mutations and VoCs are spreading.

Aggregate data obtained by the company from the Program and other testing partners will be made available to COVID-19 vaccine or therapeutic developers to develop new tools to combat the ever-changing nature of SARS-CoV-2.

Aggregate data from the program may be used by therapeutic manufactures to obtain a large-scale view of the S-gene mutations most commonly circulating in a population.

This data may help design next-generation COVID-19 vaccines to address identified common and/or emerging S-gene mutations.

Some VoCs can cause resistance to one or more of the mAb therapies authorized to treat COVID-19. As mAb therapies lose activity against some of the VOCs, manufacturers of mAb therapies will need to design new antibodies targeting the altered Spike proteins. qPCR-based mutation data and sequencing data developed by Applied DNA's in-house NGS capacity will be made available to manufacturers.

Applied DNA will supply aggregate data back to Northwell Health to re-associate the results with the patients who provided the samples with such re-associations potentially yielding unique disease pathogenesis correlated with specific mutations to improve the standard of care based on specific mutations.