- Confirms Assay Kits’ Value in Tracking New
SARS-CoV-2 Variants in Surveillance and Diagnostic Testing -
- Vast Majority of PCR and Antigen Testing
Unable to Detect Currently Known Variants -
- Multiple-Targets Assay Design Provides for
Positive Results for Infected Individuals, while S-Gene “Dropout”
Signals the Presence of a Variant –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing,
today announced that its Linea™ COVID-19 Assay Kit (the “Assay
Kit”) identified COVID-19 positive samples that are variants
distinct from the wild-type virus that has dominated the U.S. in
the pandemic until now. The variants were identified as part of the
Company’s safeCircleTM pooled surveillance testing service, which
is powered by the Company’s Assay Kits. The Assay Kits are also
available for diagnostic use in third-party laboratories certified
for complex molecular diagnostics.
Beginning in December 2020, the Assay Kit identified multiple
instances of COVID-19 positive individuals whose samples evidenced
a specific S-gene mutation known as 69-70 deletion (69-70del).
Detection of samples carrying 69-70del with the Assay Kit is
accomplished via S-gene dropout observed in one of the two Assay
Kit’s SARS-CoV-2 genetic targets. Gene sequencing methods confirmed
the variants identified by the Assay Kit. The 69-70del mutation is
found in several variants, including B.1.1.7, also known as the
U.K. variant, that is characterized by increased
transmissibility.
Dr. James Hayward, president and CEO of Applied DNA, stated: “We
believe that a testing strategy that is grounded in its use of our
Assay Kit should be considered by any community, company,
government or organization that wants to surveil their cohorts for
the presence of new variants, detect them early, and take steps to
contain them. Our Assay Kit is available immediately for any
certified diagnostic lab or surveillance program.”
As announced on January 8, 2021, the U.S. Food and Drug
Administration announced that the Company’s Assay Kit was one of a
select few molecular diagnostics that could potentially identify
SARS-CoV-2 variants that contain a specific S-gene (that encodes
for Spike protein) mutation known as 69-70del. Due to the Assay
Kit’s multi-target design, the overall sensitivity of the Assay Kit
is not impacted, and a positive result is still obtained for
variant-infected samples.
The virus that causes COVID-19, SARS-CoV-2, is prone to mutate
over time, especially within patients who remain chronically
infected over months, resulting in genetic variations in the
population of circulating viral strains. Concern has been building
among scientists that new variants will dominate in American
infections by Spring, a challenge exacerbated by the inability of
the vast majority of PCR and antigen tests to specifically detect
these variants. The recent detection of multiple variants via
S-gene dropout with the Assay Kit highlights the importance of
utilizing a molecular diagnostic assay that can easily and
cost-effectively identify potential variants. The Company believes
that the identification of variants, especially the more
transmissible U.K. (B.1.1.7) and new variants from other
phylogenetic paths, is essential to containing the spread of
COVID-19.
About the LineaTM COVID-19 Assay Kit
and Pooled Surveillance Testing
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 Company is offering surveillance testing in compliance with
current CDC, FDA, and CMS guidances. The use of saliva and pooled
sampling for surveillance testing, which has been internally
validated by the Company in compliance with current surveillance
testing guidances, is not included in the Company’s EUA
authorization for the Linea™ COVID-19 Assay Kit.
To learn more about the Linea™ COVID-19 Assay Kit:
https://adnas.com/dxcovid/
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, and pre-clinical nucleic acid-based
therapeutic drug candidates.
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 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 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/20210119005276/en/
Investor contact: Sanjay M. Hurry, Applied DNA Sciences,
917-733-5573, sanjay.hurry@adnas.com Program contact: Mike
Munzer, Applied DNA Sciences, 631-240-8814, mike.munzer@adnas.com
Web: www.adnas.com Twitter: @APDN
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