FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA E...
July 31 2020 - 8:00AM
Business Wire
- Diagnostic Kit Authorized for Use on Widely
Installed RT-PCR Device and High-Throughput RNA Extraction
Robotics; Company Ramps Kit Production in Response -
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, and pre-clinical
nucleic acid-based therapeutic drug candidates, today announced
that the U.S. Food and Drug Administration (FDA) has granted an
Emergency Use Authorization (EUA) amendment that both expands the
installed base of PCR equipment platforms that can process the
Company’s LineaTM COVID-19 Assay Kit and introduces automation to
significantly increase the throughput of the assay by use of
robotic RNA extraction.
The EUA amendment extends the RT-PCR platform authorization from
the Applied Biosystems (ThermoFisher Scientific) QuantStudio™ Dx to
include Applied Biosystems’ QuantStudio™ 5 Real-Time PCR system
(“QS5”). The amendment also authorizes the use of the Hamilton
STARlet robotic automation in conjunction with the Omega Bio-tek
Mag-Bind® viral RNA Express kit to speed the process of extracting
viral RNA from specimens and drive greater testing throughput. The
Company believes the amendment can greatly enhance the efficiency
of laboratories across the country who adopt the diagnostic kit
while expanding by more than tenfold the target installed base of
authorized RT-PCR equipment. To match the potential for higher
demand, the Company is increasing production of its diagnostic
kit.
“Accessibility and turnaround times are two critical metrics for
the successful commercial implementation of a diagnostic kit to
serve communities affected by the COVID-19 crisis. With this EUA
amendment we have accomplished both – a greatly increased installed
base of RT-PCR devices upon which our assay can run, and also
increased the speed and throughput of our assay through the use of
a best-in-breed robotic platform. We appreciate the continued
collaboration of FDA in assisting us to improve the availability
and throughput of our diagnostic kit,” said Dr. James A. Hayward,
president and CEO of Applied DNA. “As COVID-19 infection numbers
spike in many parts of the country, we are also moving to increase
kit production. We have been investing aggressively in our supply
chains and established inventories to deliver greater patient
accessibility to testing and for maximal market penetration.”
Michael Mouradian, vice president of Robotics at Hamilton
Company, manufacturer of the Hamilton STARlet platform, said, “Our
mission at Hamilton each day is to supply advanced liquid handling
solutions that support the research and diagnostic testing
communities confronting the COVID-19 pandemic.”
“We appreciate the opportunity to work with Applied DNA Sciences
to help provide a reliable, reproducible RNA extraction solution,”
said Travis Butts, vice president of Omega Bio-tek, manufacturer of
the Omega Bio-tek Mag-Bind® viral RNA Express kit. “By partnering
with Hamilton, we are able to implement an automated,
high-throughput solution that can be deployed quickly and allow
customers like Applied DNA Sciences to meet the demand for COVID-19
testing.”
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 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 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 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 and May 14, 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/20200731005123/en/
Investor: Sanjay M. Hurry, Applied DNA, 917-733-5573,
sanjay.hurry@adnas.com Program: Brian Viscount, Applied DNA,
631-240-8877, brian.viscount@adnas.com Web: www.adnas.com
Twitter: @APDN
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