- Company Updates on Progress of Applied DNA
Clinical Laboratories CLEP-CLIA Certification -
Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, announced that the U.S. Food and Drug Administration
(FDA) has granted an Emergency Use Authorization (EUA) amendment
that expands the installed base of RT-PCR platforms that can
process the Company’s Linea™ COVID-19 Assay Kit. The EUA amendment
extends the RT-PCR platform authorization from Applied Biosystems’
(ThermoFisher Scientific) QuantStudio™ Dx and QuantStudio™ 5
Real-Time PCR systems to include Applied Biosystems™ 7500 Fast Dx
Real-Time PCR System (ABI 7500). The ABI 7500 has the capacity to
perform 400 – 800 tests in 24 hours and is found in the majority of
clinical laboratories nationally.
“With this amendment to our EUA, we significantly increase the
number of authorized devices on which our assay kit can run and
remove a gating factor to the more widespread adoption of our high
sensitivity test,” said Dr. James A. Hayward, president and CEO,
Applied DNA. “We are actively engaged with clinical laboratories
nationally with which our opportunities for assay kit contracts are
bolstered by the addition of an RT-PCR system in wide use by the
diagnostics industry. Additional planned amendments, we believe,
will further differentiate our assay in the marketplace and to
operators of clinical diagnostic labs.”
Update on Applied DNA Clinical Laboratories CLEP-CLIA
Certification
Separately, the Company announced that an inspection report from
the State of New York Department of Health (DoH) following the
DoH’s initial inspection of Applied DNA Clinical Laboratories, LLC
(ADCL) on October 7, 2020, highlighted deficiencies in ADCL’s
clinical standard of practice at the time of inspection that
require remediation prior to the submission of a re-inspection
request. The Company expects to complete remediation actions during
the first calendar quarter of 2021. In the interim, ADCL’s
safeCircle™ platform, its pooled COVID-19 surveillance testing
program that does not require CLEP-CLIA certifications, is
leveraging infrastructure designated for diagnostic testing to
support safeCircle clients and Applied DNA’s internal surveillance
testing program for employees.
“While disappointed with the push-out in our CLEP-CLIA
certification timeline, our pooled surveillance testing platform
can generate more revenue per pooled sample comprising 5
individuals than from the diagnostic testing of 1 individual in the
same amount of time and using the same personnel, procedures, and
equipment,” concluded Dr. Hayward. “Surveillance testing is readily
scalable, and in recent weeks, we have concentrated our efforts on
ramping up surveillance testing capacity. Our sales efforts are
focused on tapping into the need for consistent, ongoing, and high
sensitivity PCR-based COVID-19 testing that is becoming as
foundational to stopping the spread of the virus as masks,
handwashing, and social distancing. We believe the value of our
safeCircle platform is that its sensitivity allows our clients to
identify and isolate infected populations early - in many cases
before population members suspect they are ill – to help break the
chain of transmission that could otherwise fuel the exponential
growth of COVID-19.”
About safeCircle™
ADCL’s pooled surveillance testing platform, known as
safeCircle™, utilizes frequent, high-sensitivity pooled testing to
help prevent virus spread by quickly identifying infections within
a community, school, or workplace. safeCircle provides 24-hour
results using real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your
community, school, and workplace: safeCircle
About the
Linea™
COVID-19 Assay Kit
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 pooled surveillance testing in
compliance with current CDC, FDA, and CMS guidances. The use of
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 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 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, FDA and/or CMS, 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 12, 2019 and our subsequent
quarterly reports on Form 10-Q filed on February 6, 2020, May 14,
2020 and August 6, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201125005441/en/
Investors: Sanjay M. Hurry, Applied DNA Sciences,
917-733-5573, sanjay.hurry@adnas.com Program: Mike Munzer,
Applied DNA Sciences, 631-240-8814, mike.munzer@adnas.com
Web: www.adnas.com Twitter: @APDN
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