Applied DNA Signs Master Services Agreement with Stony Brook University Hospital for COVID-19 Diagnostic Assay Kit & Automate...
September 29 2020 - 9:40AM
Business Wire
- Ensures Access to High Sensitivity, 100%
Specificity High-Throughput Assay Kit to Meet Testing Needs
-
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing that enables in vitro diagnostics, pre-clinical
nucleic acid-based therapeutic drug candidates, supply chain
security, anti-counterfeiting and anti-theft technology, today
announced the signing of a Master Services Agreement (MSA) with
Stony Brook University Hospital (“SBUH”), the largest academic
medical center on Long Island, N.Y. Under the terms of the one-year
MSA, Applied DNA will supply its EUA authorized LineaTM COVID-19
Assay Kit (the “Assay Kit”) to SBUH on an as-needed basis.
Concurrently, the Company announced the receipt of an initial
purchase order under the MSA. Terms of the MSA and initial purchase
order were not disclosed.
Under the MSA, the Company designed and implemented an
automated, high-throughput COVID-19 testing workflow in the SBUH
clinical lab. The implemented high-throughput testing workflow is a
fully integrated offering that includes equipment, software, and
services leased through the Company, including robotic RNA
extraction, robotic sample preparation, and RT-PCR custom software
and interfaces with laboratory information systems. The testing
workflow offers the SBUH clinical lab enhanced operational
flexibility and an enhanced testing capacity with the Assay Kit.
The Company is willing to offer similar equipment arrangements to
other diagnostic labs looking for high sensitivity, high throughput
testing solutions for COVID-19.
COVID-19 diagnostic testing with the Assay Kit can be performed
on a variety of PCR and nucleic acid extraction platforms using
samples obtained from nasopharyngeal (NP) swabs or less intrusive
anterior nasal (AN) swabs. Recent changes in the laws governing
Laboratory Developed Tests (LDTs) allow certified laboratories to
use the kit to tailor assays within a single certified laboratory
for the device platforms they already have on hand. Saliva sampling
and pooled testing methods for the Assay Kit have been developed by
the Company for scaled Surveillance Testing within communities and
organizations.
“Our collaboration and integration of high throughput automation
and data systems with SBUH validates our complete solution. We are
thrilled that SBUH chose our Assay Kit to meet its ongoing and
evolving needs for a highly sensitive, high-throughput PCR-based
diagnostic,” stated Dr. James A. Hayward, president and CEO of
Applied DNA. “Our Assay Kit used in conjunction with the
high-throughput workflows implemented by the Company at SBUH’s
clinical lab gives SBUH a strong testing infrastructure to enable
the testing of multiple affiliated populations, including patients,
staff, and our surrounding community.”
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.
About the LineaTM COVID-19 Assay Kit
The LineaTM 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 LineaTM 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.
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 the possibility
of a failure to make timely payment on its outstanding secured
convertible notes and resulting enforcement by noteholders of
remedies on collateral which includes substantially all of Applied
DNA’s assets, 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 partners 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, 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/20200929005161/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
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Apr 2023 to Apr 2024