APDN stock rose in early trading on April 7, 2021, after the company announced its product would track COVID-19 variants/mutations.
Applied DNA Sciences, Inc. (NASDAQ: APDN), 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.
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).
Propaganda Science of Mutations
Mutations of COVID-19 are not something to be concerned about, according to most scientists and doctors. Throughout our recorded history of mutations, we know that nearly every virus, when it mutates, it becomes less deadly. The reason is that the virus wants to survive, so it’s adapting to humans and becoming less deadly. A virus may mutate to become more contagious, but in 99.9% of all virus mutations ever recorded in the populace, the mutations are less deadly, not more. Check out this educational video from Canadian doctors that was banned off social media because they don’t want you knowing the truth about mutations:
The mainstream media (CNN, NBC, ABC, CBS, etc) are running propaganda fear videos masquerading as news to scare the public. This should bode well for APDN stock.