- Linea™ COVID-19 Assay Kit Likely Subject to
Unique Double S-Gene Target Drop, Enables Rapid Reflex Testing of
Positive Samples to Confirm Probable Presence of Omicron Without
Sequencing -
- Company to Submit Validation Data to New York
Department of Health for Linea™ 2.0 Assay to Service All
safeCircle™ Customers in the Event of Omicron Prevalence -
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, today announced
its COVID-19 diagnostic strategy in response to the emergence of
Omicron (B.1.1.529), a newly identified SARS-CoV-2 variant of
concern. The Company plans to introduce its Linea™ 2.0 COVID-19
Assay (“Linea 2.0”), a new RT-PCR assay for the SARS-CoV-2 E and N
genes that builds on the Company’s established COVID-19 line of
diagnostics, after submission of its validation data to the New
York State Department of Health (NYSDOH) in the next few days.
The Company also announced that its EUA-authorized Linea™
COVID-19 Assay Kit (the “Linea 1.0 Assay”) likely exhibits a unique
double S-gene target failure (or “drop”) (SGTF) specific to the
Omicron variant. While other assays have been shown to have SGTF
based on the presence of the Δ69-70 mutation contained in Omicron,
this specific mutation is shared across several SARS-CoV-2 lineages
and is not specific to the new variant. Based on the Company’s
initial analysis, the Company believes that the combination of
mutations that cause the unique double SGTF in the Linea 1.0 Assay
is unique to Omicron. This unique double SGTF may result in false
negative results in patients infected with the Omicron variant when
tested with the Linea 1.0 Assay as a primary diagnostic. This
unique pattern may, however, allow the Linea 1.0 Assay to provide a
high-specificity reflex test for the Omicron variant. More
specifically, the Linea 1.0 Assay may be potentially used as a
reflex test to indicate the presence of Omicron in samples that
have tested positive for COVID-19 via third-party assays that
cannot discriminate for the new variant because these same samples
will test negative on the Linea 1.0 Assay due to the unique double
SGTF.
Analysis in silico of the mutations represented in the Omicron
variant’s genome sequences publicly available in GISAID (the online
SARS-CoV-2 genome sequence database) shows that neither of the
Linea 2.0 Assay targets are affected by the variant’s mutations.
Validation testing for the Linea 2.0 Assay for both single sample
and pooled testing is already complete. The Company intends to
submit its validation data as a Laboratory Developed Test (LDT) to
the NYSDOH in the next few days. The validation data for the Linea
2.0 Assay show the performance of the new assay meets or exceeds
the performance of the Linea 1.0 Assay.
Dr. James A. Hayward, president and CEO of Applied DNA, stated,
“Viruses evolve; it is in their nature. The potential need to
evolve the Linea Assay 1.0 assay was anticipated and spurred the
side-by-side development of our Linea SARS-CoV-2 Mutation Panel and
the Linea 2.0 Assay to utilize the same testing workflows
established for the Linea 1.0 Assay that brought high specificity,
high sensitivity, and rapid time to results for population-scale
testing. We continue to service our safeCircle™ clients with the
Linea 1.0 Assay unless or until health officials indicate the
presence of Omicron in our operating area, at which point we will
transition to the Linea 2.0 Assay to provide seamless testing
services to our customers. While viruses may evolve, ours is an
unwavering commitment to providing gold-standard PCR-testing to
meet the need for COVID-19 testing.”
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 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 or testing services
could become obsolete or have its utility diminished and the
unknown amount of revenues and profits that will results from
Applied DNA’s testing contracts. 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,
equivalent foreign regulatory agencies and/or the New York State
Department of Health (NYSDOH), and whether and when, if at all,
they will receive final authorization, clearance or approval from
the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the
unknown outcome of any applications or requests to FDA, equivalent
foreign regulatory agencies and/or the NYSDOH, the unknown limited
duration of any EUAs from the FDA, changes in guidance promulgated
by the CDC, FDA, CMS an/or NYSDOH relating to COVID-19 testing,
disruptions in the supply of raw materials and supplies, continued
mutations of the SARS-CoV-2 virus, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211129005253/en/
Investor Contact: Sanjay M. Hurry, 917-733-5573,
sanjay.hurry@adnas.com Program Manager: Dr. James A.
Hayward, 631-240-8800, info@adnas.com Web: www.adnas.com
Twitter: @APDN
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