– Demand for Testing-as-a-Service
Increases–
– Highly Sensitive Pooled Surveillance Testing
Platform Demonstrates Ability to Detect Local Infections and
Prevent Clusters –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing that enables diagnostics in vitro, pre-clinical
nucleic acid-based therapeutic drug candidates, supply chain
security, anti-counterfeiting, and anti-theft technology, today
announced that it plans to boost its COVID-19 testing capacity at
Applied DNA Clinical Laboratories, LLC (“ADCL”), its wholly-owned
subsidiary, to support the reception to ADCL’s surveillance
testing-as-a-service offering enhanced by ongoing sales and
marketing outreach efforts amid a national surge in coronavirus
cases. Capacity expansion will be achieved through the phased
deployment of additional robotic automation that will enable
increased surveillance testing throughput by a significant
multiple.
“Our emphasis on expanding the throughput of our surveillance
testing program is strategic: on average, we can generate more
revenue per test with pooled surveillance testing of multiple
individuals simultaneously than from diagnostic testing of single
individuals only,” said Dr. James A. Hayward, president and CEO,
Applied DNA. “Our expansion plans align with a strong response to
our sales and marketing programs at both regional and national
levels for our surveillance testing. We continue to develop our
pipeline of surveillance testing and related Linea™ COVID-19
diagnostic assay kit opportunities and now includes certain
athletics programs and the staff and faculty of a large academic
institution. Furthermore, we have added numerous new clients since
our recent announcement of initial surveillance testing contracts.
It is clear to us that our surveillance program is being
increasingly seen as a powerful tool to protect classrooms,
workplaces, and other populations from COVID-19.”
ADCL’s pooled surveillance testing program, 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.
The Company has taken delivery from robotics manufacturers to
enhance the throughput for COVID-19 testing. Planned expansions
include increased production of Applied DNA’s Diagnostic Assay Kit
(“Assay Kit”) that powers safeCircle surveillance testing;
increased sample pooling operations for high-throughput
surveillance testing at ADCL and pooling support at a major
academic institution; and in high-throughput viral RNA extraction
and plate assembly. The Company has also installed and validated
additional PCR instruments that will be deployed in its
surveillance testing programs. These validations will also serve as
the basis for further amendments to the Company’s EUA authorized
Assay Kit for diagnostic testing.
“Recent surveillance testing successes are amplifying the value
proposition of safeCircle in the marketplace,” concluded Dr.
Hayward. “In recent weeks, we have uncovered early infections in
populations and cohorts that had tested negative via rapid antigen
tests both immediately before and immediately after our positive
surveillance testing. Individuals in these populations subsequently
developed symptoms. Given our surveillance testing accuracy, we
believe we prevented the development of COVID clusters within these
tested populations and cohorts. We look to bring the same
capabilities with an expanded capacity to grow our market presence
regionally and elevate our profile nationally.”
Surveillance versus Diagnostic
Testing
Surveillance testing looks for infection within a defined
population and can be used to make important health management
decisions at the population level. Specimen collections are
conducted via nasopharyngeal or anterior nasal swabs, and via
saliva sampling, and pooled. Pooled test results are returned to
the sponsoring organization in the aggregate, not directly to the
individual, and may be performed without CLIA certification.
Surveillance testing does not require a prescription.
In comparison, diagnostic testing looks for the occurrence of
COVID-19 at the individual level. Diagnostic testing requires a
prescription, and results are returned to the individual or their
healthcare provider.
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 the 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 pooled
nasopharyngeal or anterior swabs or saliva 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201030005142/en/
Investor contact: Sanjay M. Hurry, Applied DNA Sciences,
917-733-5573, sanjay.hurry@adnas.com Program contact:
Mike Munzer, Applied DNA Sciences, 631-240-8800,
mike.munzer@adnas.com Web: www.adnas.com Twitter:
@APDN
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