- Program to Support Weekly Testing of Up to
9,000 Faculty and Staff at Peak Operations, Equates to Use of
Approximately 1,800 Tests per Week; Applied DNA Receives Initial
Stocking Order Under Master Services Agreement -
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 Linea™ COVID-19 Assay Kit
(the “Assay Kit”) has been selected by Stony Brook University
Hospital (SBUH) for use in SBUH’s newly launched COVID-19
surveillance testing program (the “Program”). At peak operations,
the Program will utilize frequent pooled testing to enable the
early detection and response for potential COVID-19 cases across
the 9,000-member faculty and staff of SBUH and Renaissance School
of Medicine. In this surveillance testing modality, the Company
expects to provide up to 1,800 (5 individuals per pooled test) of
its Linea™ COVID-19 tests per week.
Applied DNA has received an initial stocking order under its
Master Services Agreement (MSA) with SBUH for 3,400 tests and
related consumables to enable the pooled testing of 17,000
individuals. The Company expects the receipt of recurring purchase
orders for Assay Kits and consumables for the Program.
The Program is modeled after the Company’s proprietary
safeCircle™ platform, a pooled surveillance testing program
developed and used in-house by the Company’s Applied DNA Clinical
Laboratories (ADCL) subsidiary. safeCircle utilizes the Company’s
Assay Kit in conjunction with an automated, high-throughput testing
workflow and equipment, software, and services to return pooled
surveillance test results typically within 24 hours.
“Workplaces, classrooms, and communities are beginning to
recognize pooled surveillance testing as an effective and
cost-efficient means of monitoring virus activity at local, state,
and national levels. Offering our high sensitivity Assay Kit for
use in a surveillance testing modality creates additional sales
opportunities,” stated Dr. James A. Hayward, president and CEO,
Applied DNA. “We can service burgeoning demand for surveillance
testing in-house at ADCL, and as we recently reported, the activity
level in our sales pipeline is such that we are in the process of
expanding its surveillance testing capacity. We can also empower
any laboratory equipped with authorized equipment to launch their
own pooled surveillance testing capacity through the implementation
of the safeCircle platform.”
Concluded Dr. Hayward, “It is our privilege to work alongside
SBUH on our mutual goal to mitigate COVID-19 spread in our
community.”
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 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 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/20201110005247/en/
Investor contact: Sanjay M. Hurry, Applied DNA Sciences,
917-733-5573, sanjay.hurry@adnas.com Program contact: Brian
Viscount, Applied DNA Sciences, 631-240-8877,
brian.viscount@adnas.com Web: www.adnas.com Twitter:
@APDN
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