- Linea™ COVID-19 SGS™ Mutation Panel Can
Identify ‘Mutations of Therapeutic Concern’ that May Lessen
Response to Certain Therapies -
- As the Prelude to Whole Viral Genome
Sequencing, Mutation Panel Empowers Pursuit of Specific Variant
Lineages and Can Minimize Sequencing of Wild Type Virus -
- Company Initiates Development of New Assay to
Characterize B.1.617 (Indian) Variant and Sub-Variants -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, today announced that it has competed technical
validation of all seven Research Use Only (RUO) mutation detection
assays contained in its Linea™ COVID-19 Selective Genomic
Surveillance™ (SGS) Mutation Panel (the “SGS Panel”) across 125
COVID-19 positive clinical samples known to include COVID-19
variants. The results showed 100% concordance when compared to the
results of Whole Genome Sequencing (WGS) of the same samples (see
table below for a listing of all mutation detection assays and
currently associated Variants of Concern (VoC) or Variants of
Interest (VoI)). The SGS Panel can be run in hours and can utilize
the same extracted viral RNA that was used to obtain the original
COVID-19 diagnosis. The SGS Panel will be available on a RUO basis
and cannot be used for diagnostic purposes. Based on its successful
technical validation, the Company plans to seek EUA-authorization
for its SGS Panel.
The SGS Panel contains assays targeting seven different
mutations, including the L452R and E484K mutations that have been
designated by the Centers for Disease Control and Prevention (CDC)
as ‘Substitutions (mutations) of Therapeutic Concern’ due to
potential impacts on the efficacy of certain EUA-authorized
antibody treatments1. One or both mutations are found in all
current CDC-designated VoCs and VoIs, except the B.1.17 (UK
variant) VoC. The inclusion of the L452R and E484K assays, together
with the Company’s WGS concordance data, validates the SGS Panel’s
ability to characterize all current CDC-designated VoCs and VoIs,
excluding the B.1.1.7 VoC that can be detected via S-gene dropout
by the Company’s Linea COVID-19 Assay Kit.
In mutation surveillance studies utilizing 924 COVID-19 positive
samples conducted by the Company with the SGS Panel, a combined
L452R and E484K mutation frequency of 38% (12% and 26%,
respectively) was found. These identified samples containing
mutations of therapeutic concern should be subjected to WGS, as
they have a higher probability of being a VoC or VoI as compared to
samples that do not contain these mutations. The Company believes
this rational selection of samples for WGS via the SGS Panel can be
used to optimize the use of constrained Next Generation Sequencing
(NGS) assets nationality, which currently do not provide capacity
for widescale genomic surveillance via WGS. For context, for the 30
and 180 days ended May 24, 2021, the U.S. has sequenced and shared
only 3.06%2 and 1.91%2 of all reported COVID-19 cases,
respectively.
The Company is also undertaking the development of an assay to
detect the E484Q mutation that, together with L452R, specifically
characterize B.1.617, the Indian variant that was first detected in
the U.S. in April 2021 and theorized to have increased
transmissibility3 (up to 50%) over that of the UK variant, which
itself is up to 45%3 more transmissible than SARS-CoV-2 Wild Type.
The E484Q assay will be added to the SGS Panel upon validation.
“With fully half of the U.S. population yet to be vaccinated and
the arrival of a potentially more transmissible SARS-CoV-2 Indian
variant, this calls for more and not less surveillance and
coordination of efforts to identify and characterize variants. We
believe our SGS Panel gives Federal- and State-level public health
officials the accurate, high-throughput mutational-surveillance
tool they need to identify and act on variants quickly. Further, we
believe it is a tool that allows for the rapid and inexpensive
identification of the L452R and E484K mutations currently worrying
the clinical community,” said Dr. James A. Hayward, president and
CEO of Applied DNA. “We are working diligently to seek
EUA-authorization and elevate the capabilities and value
proposition of our SGS Panel to federal and state public health
authorities as an essential tool to stay ahead of the curve on all
current and emerging variants.”
The SGS Panel
The SGS Panel is a research use only (RUO) mutation-detection
panel comprised of multiple qPCR assays that target the salient
SARS-CoV-2 mutations known to characterize certain virus mutations.
It was developed to detect specific mutations as a fast,
cost-effective screening tool to focus the U.S. NGS capacity on the
most impactful SARS-CoV-2 variants. The SGS Panel will be available
on a RUO basis and cannot be used for diagnostic purposes.
Click here to learn more about the SGS Panel.
Mutations Identified by Linea COVID-19
Assay Kit and SGS Panel
Variant
Mutation
69-70del
E484K
N501Y
P681H
S477N
L452R
K417N
B.1.1.7 (UK)
√
√
√
B.1.617* (India)
√
B1.351 (S. Africa)
√
√
√
P.1 (Brazil)
√
√
P.2 (Brazil)
√
B.1.526 (NY)
√
√
B.1.526.1 (NY)
√
B.1.427/B.1.429 (CA)
√
* Includes all sub-variants
Footnotes:
1https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-updates%2Fvariant-surveillance%2Fvariant-info.html
2https://www.gisaid.org/index.php?id=208
3https://www.bloomberg.com/news/articles/2021-05-23/cdc-ramps-up-research-on-highly-contagious-variant-from-india
4https://www.cidrap.umn.edu/news-perspective/2021/04/covid-19-scan-apr-21-2021
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 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.
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.
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 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 the assay kits could become obsolete or have
its utility diminished, the possibility that the SGS Panel
will never receive Emergency Use Authorization (EUA) approval from
U.S. FDA, be commercialized or results in any revenues to Applied
DNA, 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
or authorization 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 guidance 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 Quarterly Reports on Form 10-Q
filed on February 11, 2021 and May 13, 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/20210526005600/en/
For Applied DNA: Investor contact: Sanjay M.
Hurry, 917-733-5573, sanjay.hurry@adnas.com Program contact:
Dr. James Hayward, 631-240-8801, james.hayward@adnas.com
Web: www.adnas.com Twitter: @APDN
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