Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and Northwell Health (Northwell) today announced their entry into a pro bono Material Transfer Agreement (MTA) that establishes a real-time surveillance program for the tracking and identification of SARS-CoV-2 mutations and variants of concern (VoCs) in Northwell’s COVID-positive specimens (the “Program”). 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 (“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 (NGS) 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.
“We believe that the combination of our Assay Kit and SGS Mutation Panel as a method of prescreening COVID-19 positive specimens presents a rational approach to the use of nationally constrained next-generation sequencing capacity. The participation of Northwell, New York State’s largest healthcare system and among the largest in the nation, validates our approach that utilizes our newly established SGS Mutation Panel and NGS capabilities,” said Dr. James A. Hayward, president and CEO, Applied DNA. “The ability to identify high-value positive samples containing certain mutations that should be subject to NGS should enable the more efficient discovery and tracking of VoCs that could greatly improve the nation’s ability to track and stay ahead of the variants. If taken up broadly in the U.S., we believe that national NGS resources could be more precisely targeted toward variants of the strongest epidemiological relevance via the use of our SGS Mutation Panel.
“Another top priority with our SGS Mutation Panel is to enable improved diagnostics that may yield improvements in therapeutic outcomes and patient clinical care. As we gather data from the Program and other specimens being run on the SGS Mutation Panel, the incidence rates of specific mutations identified by our qPCR assays and NGS data, when linked to patient outcomes, the pathogenesis of their disease and their response to interventions may provide valuable data for clinical care, vaccine design, booster design and choice of targets for antibody and other therapies,” concluded Dr. Hayward.
“The Applied DNA Sciences approach permits rapid and inexpensive identification of mutations that are concerning in the clinical community, such as the E484K and L452R mutations which may confer resistance to some therapies or specific antibodies,” said Dr. Dwayne Allen Breining, executive director of Northwell Health Labs.
Data generated from the Program may be relevant to:
- COVID-19 vaccine manufacturers – 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;
- COVID-19 mAB (monoclonal antibody) therapy manufacturers – 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;
- Precision medicine – 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.
Applied DNA’s SGS Mutation Panel is designed to enhance the effectiveness of the limited NGS resource. The Company has developed a Research Use Only (RUO) panel of eight qPCR assays that target the salient mutations that characterize (and in some cases are shared by) the Variants of Concern (VoCs). When used in conjunction with the Company’s Assay Kit, the SGS Mutation Panel currently screens for the following mutations: 69-70del, E484K, N501Y, P681H, S477N, L452R, K417, and N439K with additional relevant mutation targets added as they arise. The qPCR assay-based analysis of SARS-CoV-2 positive samples can quickly, and cost effectively, provide valuable mutation related data points on large numbers of specimens without NGS characterization and also be used to select high-value samples to subject to NGS. The SGS Mutation Panel complements the Assay Kit that is the only EUA RT-PCR assay to target two amplicons in the S gene of SARS-CoV-2, and which experiences S-drop when testing specimens containing the 69-70del mutation, while providing a positive test result due to the unaffected second S gene assay target. Applied DNA’s NGS platform is a high throughput device that can be utilized to sequence up to 200 viral genomes per day.
About the Linea™ COVID-19 Assay Kit and the Linea™ COVID-19 Selective Genomic Surveillance™ (SGS) Mutation Panel
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.
The Linea™ COVID-19 Selective Genomic Surveillance™ (SGS) Mutation Panel (the “SGS Panel”) is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The SGS Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority. In addition, all NGS services to be offered by the Company will be for Research Use Only (RUO).
About Northwell Health
Northwell Health is New York State’s largest health care provider and private employer, with 23 hospitals, 830 outpatient facilities and more than 16,600 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 76,000 employees – 18,900 nurses and 4,800 employed doctors, including members of Northwell Health Physician Partners – are working to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We're training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, Twitter, Instagram and LinkedIn.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020, and Form 10-Q filed on February 11, 2021 and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.