- Panel is Designed for the Qualitative
Detection of Four SARS-CoV-2 Genomic Mutations, Three of Which are
Classified by the CDC as Substitutions of Therapeutic Concern -
- Panel is Designed to Serve as a Rapid
Alternative to Next Generation Sequencing to Identify Patients
Infected with COVID-19 that Contain Specific Mutations that May
Impact the Efficacy of Certain Antibody Treatments -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing and nucleic acid-based technologies, announced that
it has submitted its request for Emergency Use Authorization (EUA)
to the U.S. Food and Drug Administration (FDA) for its Linea™
SARS-CoV-2 Mutation Panel (the “Mutation Panel”). The Mutation
Panel is designed for the qualitative detection of the E484K,
E484Q, L452R, and N501Y SARS-CoV-2 genetic mutations in samples
that have tested positive for COVID-19 on the Company’s EUA
authorized Linea™ COVID-19 Assay Kit. The E484K, L452R, and N501Y
mutations have been identified by the Centers for Disease Control
and Prevention (“CDC”) as potentially having a negative impact on
the efficacy of certain anti-SARS-CoV-2 monoclonal antibody
treatments (“mAb”) and have been identified by the CDC as
substitutions of therapeutic concern.
The Mutation Panel is comprised of four separate Single
Nucleotide Polymorph (“SNP”) genotyping assays that utilize allelic
discrimination plot analysis to identify whether a sample contains
the wildtype or mutant sequence for the targeted mutation. The
Mutation Panel is configured to be used with high-throughput
robotic extraction platforms and RT-PCR analysis on the QuantStudio
Dx RT-PCR instrument. During validation studies, the Mutation Panel
showed 100% concordance with the results obtained from Next
Generation Sequencing (NGS).
Dr. James A. Hayward, president and CEO of Applied DNA, stated,
“Distribution of a previously EUA-authorized, single-agent mAb
treatment was halted due to SARS-CoV-2 mutations that are detected
by our Mutation Panel. In addition, a currently EUA-authorized mAb
treatment is known to be negatively impacted by mutations detected
by our Mutation Panel. As such, we believe that if the Mutation
Panel becomes EUA-authorized, testing for the genetic mutations
targeted in our Mutation Panel may be warranted prior to the
administration of mAb treatments known to be impacted by some of
the mutations detected by our Panel, especially in geographic areas
where the mutations are known to be circulating.
“In addition, we believe we have developed an efficient workflow
for the discovery and validation of SNP genotyping assays for the
detection of SARS-CoV-2 mutations. Should new mutations gain
prevalence, such as those in the AY4.2 variant, we believe we are
well-positioned to rapidly offer additional SNP genotyping assays
for the detection of new mutations,” concluded Dr. Hayward.
While the rise of Delta has potentially reduced the genomic
heterogeneity of SARS-CoV-2 in the United States, genetic
variations that can give rise to additional new mutations and
variants continue to be of concern. The recent rise of the AY4.2
(“Delta plus”) variant in the United Kingdom, with new mutations in
the Spike protein, highlight the continued risk of SARS-CoV-2
mutations. The emergence of new mutations or the re-emergence of
known mutations underlies the importance of our efforts to develop
and provide tools that can rapidly identify mutations of concern to
assist healthcare providers in determining appropriate treatments
for COVID-19 patients.
The FDA has not yet authorized the Mutation Panel for emergency
use, and there is no guarantee that the Company’s EUA application
will be authorized by FDA.
About the Linea™ SARS-CoV-2 Mutation Panel The
Linea™ SARS-CoV-2 Mutation Panel (the “Mutation Panel”) is
comprised of multiple SNP genotyping assays designed to detect
known SARS-CoV-2 genomic mutations. The Mutation Panel is not
currently EUA-authorized, is available for Research Use Only (RUO)
and cannot be used for clinical diagnostic purposes. The Mutation
Panel has not been approved or authorized to diagnose, mitigate,
prevent, treat and/or detect any disease by any U.S. or
international regulatory authority.
About the Linea™ COVID-19 Assay Kit The Linea™ COVID-19
Assay Kit is a real-time RT-PCR test intended 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 (HCP).
The test is also intended for use with anterior nasal swab
specimens that are self-collected in the presence of an HCP from
individuals without symptoms or other reasons to suspect COVID-19
when tested at least weekly and with no more than 168 hours between
serially collected specimens.
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.
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 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 Gov/Mil, textiles,
pharmaceuticals and nutraceuticals, and cannabis, among others.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list. 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.
Forward-Looking Statements 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 Applied DNA’s assay kits could become obsolete or
have its utility diminished, the possibility that the Mutation
Panel will never receive EUA from FDA, be commercialized or result
in any revenues to Applied DNA. Further, the uncertainties inherent
in research and development, future data and analysis, including
whether any of Applied DNA’s or its partner’s future diagnostic
candidates will advance further in the research process or
receiving authorization, clearance or approval from the FDA or
equivalent foreign regulatory agencies and whether and when, if at
all, they will receive final authorization, clearance or approval
from the FDA or equivalent foreign regulatory agencies, the unknown
outcome of any applications or requests to FDA, equivalent foreign
regulatory agencies and/or the New York State Department of Health,
the unknown limited duration of any EUAs from the FDA, changes in
guidance promulgated by the CDC, FDA and/or CMS relating to
COVID-19 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 Quarterly Reports on
Form 10-Q filed on February 11, 2021, May 13, 2021 and August 12,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211025005244/en/
For Applied DNA: Investor: Sanjay M. Hurry,
917-733-5573, sanjay.hurry@adnas.com Program Manager: Dr.
James Hayward, 631-240-8801, james.hayward@adnas.com Web:
www.adnas.com Twitter: @APDN
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Sep 2023 to Sep 2024