U.S. FDA Lists Applied DNA’s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation...
January 08 2021 - 1:43PM
Business Wire
- Early and Cost-Effective Identification of
Samples Potentially Containing the B.1.1.7 or Other Variants May
Help Reduce Further Spread of Infection -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing,
announced today that the U.S. Food and Drug Administration (FDA)
published a safety communication (the “Communication”) that
identifies the Company’s Linea™ COVID-19 Assay Kit (the “Assay
Kit”) as one of only two tests marketed under the FDA’s Emergency
Use Authorization (EUA) that are potentially able to identify
certain SARS-CoV-2 mutations, including a mutation found in the
U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent
publications, the B.1.1.7 variant has been identified within the
United States and may be associated with an increased risk of
transmission of the virus that causes COVID-19. The identification
of certain mutations can help identify samples that should be
further characterized via genetic sequencing and can potentially
assist with the early detection of new variants in patients, which
may reduce further spread of infection. The full text of the
Communication is accessible via the URL below.
According to the Communication, the FDA monitors the potential
effects of genetic variation on molecular tests that have received
EUA, including the Company’s Assay Kit. The Communication notes
that molecular tests designed to detect multiple SARS-CoV-2 genetic
targets, such as the Assay Kit, are less susceptible to the effects
of genetic variation than tests designed to detect a single genetic
target. Based on analysis conducted by the Company and FDA, one of
the two S-gene targets (S1 and S2) of the Assay Kit has
significantly reduced sensitivity in the presence of certain S-gene
mutations, including a mutation found in the B.1.1.7 variant. The
Communication notes that the reduced sensitivity, also known as an
S-gene dropout, may be indicative of certain SARS-CoV-2 mutations,
including the B.1.1.7 variant. Due to the Assay Kit’s multi-target
design, the Communication states the Assay Kit’s overall
sensitivity should not be impacted.
“Our ability to potentially identify certain variants of
SARS-CoV-2 is grounded in the multi-target design of our assay that
mitigates the impact of a mutation to the S-gene on test
sensitivity. We believe our Assay Kit can give public health
officials and diagnostic laboratories a fast and cost-efficient
tool – whether through diagnostic or pooled surveillance testing –
with which to potentially identify and track B.1.1.7 spread that is
made all the more challenging by the variant’s apparent
transmission advantage,” said Dr. James A. Hayward, president and
CEO, Applied DNA. “Using our Assay Kit, we have already identified
variants of SARS-CoV-2 via S-gene dropout, sequenced the identified
variants with partners and identified common genetic progenitors
that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants.
Utilizing this knowledge, we have begun to develop new assays to
detect specific mutations in SARS-CoV-2 and to adapt our assay to
address the evolving SARS-CoV-2 threat.”
Link to FDA safety communication:
https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory
About the Linea™ 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.
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/20210108005522/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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