Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, today announced that its wholly-owned subsidiary,
Applied DNA Clinical Laboratories, LLC (ADCL), has secured a
safeCircle™ pooled COVID-19 surveillance testing program (the
“Program”) award with a potential value of up to $2.0 million from
the Suffolk County (N.Y.) Government (the “County”). The 6-month
term and award value may be increased at the County’s discretion to
meet additional testing demand.
“In Suffolk, we know that testing is key to containing the
virus, and this new partnership with ADCL will provide all of our
employees with the peace of mind they need to continue their
critical work, as we are now fully embraced in the second wave of
the COVID-19 pandemic,” said Suffolk County Executive Steve
Bellone. “Our goal is to give our employees access to fast and
convenient testing to ensure a healthy and safe work environment,
and I encourage all County employees to take advantage of this new
testing program.”
ADCL has partnered with N.Y.-based CLEARED4 to administer
value-added services to the County by integrating CLEARED4’s
platform with safeCircle’s surveillance testing modality to
automate health safety. CLEARED4, a market-leading COVID-19 safety
platform, is now integrated with ADCL’s laboratory operations. The
partnership enables safeCircle’s clients to automate the management
and monitoring of their testing programs and improve the
communication of valuable health clearance information, thereby
ensuring the adoption of and compliance with Centers for Disease
Control and Prevention and local COVID-19 regulations.
Commenting on the award with the County, Dr. James A. Hayward,
president and CEO, Applied DNA, said, “40% of individuals who
develop COVID-19 are asymptomatic, and as an essential workforce,
County employees do not always have the luxury of working from
home. Ongoing, consistent, and proactive pooled surveillance
testing can help identify infected populations sooner and help
protect co-workers, family members, and communities. As Suffolk
County residents ourselves, we are honored to have the opportunity
to contribute to the well-being of our neighbors.”
Weekly pooled surveillance testing is being conducted using
anterior nasal swab collection systems pooled in groups of up to
five individuals per test. Individuals in positive pools identified
by the Program are referred for follow-on diagnostic testing under
a referral testing agreement between ADCL and a certified
laboratory. Per the current Centers for Disease Control guidelines,
the result of all samples testing under the Program will be
reported only in the aggregate and only to the County. Samples
referred for follow-on diagnostic testing will be reported by the
certified laboratory as per applicable laws and regulations.
About safeCircle™
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.
Click through to learn more about how safeCircle can help your
community, school, and workplace: safeCircle
About the LineaTM 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 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 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 relating to COVID-19 surveillance 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 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/20201217005955/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,
https://adnas.com/covid-19-surveillance-testing/ Twitter:
@APDN
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