Applied DNA Leverages COVID-19 Vaccine Development & Proprietary Linear DNA Manufacturing Capability to Design a High Sensiti...
March 19 2020 - 7:00AM
Business Wire
– Assay under development uses PCR-based
detection of viral sequences that code for the Spike protein that
is also the target of the Company’s vaccine candidate with Takis
Biotech –
- messenger RNA abundance for Spike in host
cells should yield high sensitivity -
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing for product authenticity, traceability solutions,
nucleic acid-based biotherapeutic development, and diagnostics,
announced today the completion of design of a diagnostic kit for
SARS-CoV-2 (the virus that causes the disease COVID-19) being
developed for production via the Company’s proprietary PCR-based
DNA (LinearDNA™) manufacturing process.
The Company’s announcement follows its statement on March 2,
2020, updating their collaborative progress with Takis Biotech, in
Rome, Italy, on a series of LinearDNA™ vaccine candidates against
the Spike protein of SARS-CoV-2. Yesterday’s announcement
highlighted that the preclinical trials for the jointly developed
vaccines have been authorized by the Italian Ministry of Health,
and are the first trials in Italy to have reached this stage.
The recently designed novel diagnostic kit focuses on the gene
that encodes the surface spike (S) protein, an essential
glycoprotein for viral entry into human host cells. Said Dr. James
Hayward, president and CEO of Applied DNA: “We aligned 74 variants
of the S-gene sequence currently available in the NCBI (National
Center for Biotechnology Information) database. This gene is highly
conserved, being close to 100% (99.97%) identical across variants;
meaning that detection via our diagnostic kit under development
should be consistent even against the capacity for this virus to
mutate. We believe that we are the first company to engage both in
detection and prevention of COVID-19.”
“After in-silico analysis, the assay appears highly accurate and
specific for SARS-CoV-2”, said Yuha Sun, Director of Applied
Genomics at Applied DNA, and one of the developers of the assay.
“Applied DNA plans to conduct in-vitro verification of the
in-silico analysis in the coming weeks.”
“Because the Spike protein is very abundant on the virus
surface, many copies of the messenger RNA are present per host
cell, increasing, we believe, the probable sensitivity of the
diagnostic,” said Dr. Mohan Chellani, Director of Diagnostic
Regulatory Affairs at Applied DNA.
The Company will undertake the PCR-based manufacture of the
positive controls for its proposed kit under its LinearDNA platform
and believes that its capacity for such manufacture is unmatched
anywhere in the world. “We are approaching partners for the
validation of our pending diagnostic with samples from confirmed
COVID-19 patients,” continued Dr. Hayward. “We believe our capacity
for PCR-based manufacture of linear DNA could be of utility to
other diagnostic and vaccine manufacturers.”
Applied DNA makes clear that no commercial partner has been
identified to take the developmental diagnostic to market, nor is
there any indication that the Company’s diagnostics would be
approved by regulators. The assay will use the Applied Biosystems
7500 Fast Dx Real Time PCR instrument, widely deployed in
diagnostic labs and hospitals the world over. Once fully validated
and ready for shipment, the Company plans to sell the diagnostic
kit as “For Research Use only” while awaiting the potential
Emergency Use Authorization by FDA, which would empower sales to
diagnostic labs.
About Applied DNA Sciences, Inc. Applied DNA is a
provider of molecular technologies that enable supply chain
security, anti-counterfeiting and anti-theft technology, product
genotyping, diagnostics 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. Common stock listed on NASDAQ
under the symbol APDN.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc
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 fact that there has never been a commercial drug
product utilizing PCR-produced DNA technology approved for
therapeutic use, the uncertainties inherent in research and
development, future clinical data and analysis, including whether
any of Applied DNA’s or its partners product 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 to U.S. FDA 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 report on
Form 10-Q filed on February 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.
web: www.adnas.com, www.adnas.com/linearx twitter:
@APDN
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version on businesswire.com: https://www.businesswire.com/news/home/20200319005135/en/
investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com
program contacts: Brian Viscount, Applied DNA,
631-240-8877, brian.viscount@adnas.com
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