STONY BROOK, N.Y.--(BUSINESS WIRE)--Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company,” “our”) today announced that it applied prior to the end of April for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Linea™ COVID-19 diagnostic candidate to detect SARS-CoV-2, the novel coronavirus that causes the disease COVID-19. Validation for the EUA was completed in collaboration with Stony Brook University Hospital; the company’s neighbor and collaborator on campus.
We believe that Applied DNA is one of the only companies engaged both in the detection of the virus and in its prevention. The diagnostic assay, which uses a method known as “real-time, Reverse Transcription PCR (rRT-PCR, or Polymerase Chain Reaction),” detects minute quantities of the viral S gene (as few as 1.25 copies), lowering the probability of “false negatives.” To design the assay, the Company aligned 74 variants of the S-gene sequence currently available in the NCBI (National Center for Biotechnology Information) database. Results showed this gene to be highly conserved, being close to 100% (99.97%) identical across variants. Detection via our diagnostic kit should be consistent across these variants, and perhaps new variants which have yet to arise.
The assay is designed to be run in high-throughput workflows that enable same-day results to be transmitted to the ordering physician. In a spirit of continuous innovation and improvement of the end-to-end process of patient diagnosis, the Company is investigating methods to enhance the assay to increase the ease of patient sampling by using saliva instead of invasive nasopharyngeal swabbing methods.
Both aspects of the Company’s COVID-19 platform (detection and prevention) target the protein (and its viral gene) that enables the virus to gain entry into human cells. Called “Spike” because of its novel appearance on the surface of the virus, in cross-section, it appears like crown, giving the virus its “corona” name. Spike binds to receptors found in the upper and lower airways using that path to gain access to the inside of cells, where it commandeers the cellular machinery to replicate itself. The protein is encoded in the S gene of the virus.
As a complement to the diagnostic kit, the Company’s candidate vaccines use engineered (by partner Takis Biotech in Rome) synthetic portions of the S gene to present the antigens of the protein to the patient’s immune system, hopefully eliciting the generation of antibodies that recognize and help clear the virus from the patient, and neutralize the ability of SARS-CoV-2 to infect human cells. Early results announced yesterday, suggest that the vaccine candidates do so in test animals. The pre-clinical and clinical trial plan calls for utilizing Applied DNA’s novel DNA platform of linear DNA.
Applied DNA makes clear that while the Company has filed an EUA with the U.S. FDA, the U.S. FDA has not yet approved the Company’s diagnostic and there is no guarantee that any EUA will be approved. In addition, numerous other SARS-CoV-2 diagnostic assays are under development by other third parties or have been granted EUA approval by U.S. FDA, any of which may be more successful than the Company’s assay, and even if the Company’s assay gains EUA approval, the assay may generate only limited revenue and profits for the Company.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
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’.
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 there being no assurance that our vaccine (or diagnostic) candidate will be successfully shown to provide immunity (or detect) SARS-CoV-2, that the vaccine (or diagnostic) candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the vaccine candidate can be manufactured in large quantities or that third parties with an established presence in vaccine distribution, compliance and marketing will enter into an agreement with the Company or Takis, that positive results in animals may not be predictive of human outcomes after DNA vaccination, that numerous other SARS-CoV-2 vaccines (and diagnostics) are under development by other third parties, any of which may be more successful than the Company’s and Takis’ vaccine candidate (or the Company’s diagnostic candidate) and even if the Company’s and Takis’ vaccine candidate (or the Company’s diagnostic candidate) is successful, it may generate only limited revenue and profits for the Company, the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration 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 fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use 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 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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.