Applied DNA Secures Blanket Purchase Order for 10,000 Linea™ COVID-19 Tests
November 12 2020 - 8:00AM
Business Wire
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, today announced that it has secured a blanket
purchase order from an existing customer for its Linea™ COVID-19
Assay Kit (the “Assay Kit”) and consumables to conduct 10,000
tests. The Company has already shipped a portion of the purchase
order in the current fiscal quarter ending December 31, 2020. The
balance of the purchase order is expected to be delivered in the
current quarter. The Company anticipates recurring purchase orders
for Assay Kits and consumables from the customer.
The Assay Kit may be used for pooled surveillance testing by
non-CLIA and CLIA certified laboratories or by CLIA-certified
laboratories for molecular diagnostic testing. The Assay Kit
received Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration for use as a molecular diagnostic test in May
2020. Pursuant to the EUA, the Assay Kit is authorized for use by
CLIA-certified laboratories in the United States 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 Assay Kit is authorized to run on ThermoFisher Scientific’s
QuantStudio™ Dx Real-Time PCR Instrument and QuantStudio™ 5
Real-Time PCR System under an amendment to its EUA. Each PCR device
is capable of performing 400 to 800 tests in a 24-hour period. The
Company has applied for an additional amendment to its EUA that
would extend the authorized use of its Assay Kit to ThermoFisher
Scientific’s Applied Biosystems™ 7500 Real-Time PCR System, a
widely used RT-PCR system that has the capacity to perform a
similar number of tests to the QuantStudio 5 and QuantStudio Dx in
a 24-hour period.
About the Linea™ COVID-19 Assay Kit
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201112005184/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