Applied DNA High-Sensitivity & High-Throughput COVID-19 Diagnostic Kit Enters Validation Process in Partnership with Stony Br...
April 21 2020 - 02:00AM
Business Wire
- Paves Path for Application to FDA for
Emergency Use Authorization before end of April 2020 -
- Company providing high-throughput
RNA-extraction robotics and enhanced-sensitivity RT-qPCR assay with
goals to diminish false negatives, quantify viral loads and enhance
testing volumes for the region –
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) today announced the signing of an Agreement with Stony
Brook University Hospital (the “Hospital”) to validate and
implement the Company’s patent-pending nucleic acid diagnostic
(LineaCOVID-19™) to detect and quantify in diagnostic samples the
presence of SARS-CoV-2, the virus that causes the disease,
COVID-19. Validation is expected to begin immediately with results
to be used to support the Company’s application to the U.S. Food
and Drug Administration (FDA) before the end of April 2020 for
Emergency Use Authorization (EUA).
“Built upon our work to develop COVID-19 vaccine candidates, we
believe we have developed a high-sensitivity, high-throughput
diagnostic that is urgently needed to meet the mass testing
requirements of not just New York State, but also across the U.S.
and the world. Working together with a local partner that is
world-class medical institution, we are now at the final step of
our diagnostic kit development program before moving to seek
Emergency Use Authorization from the FDA,” stated Dr. James
Hayward, president and CEO of Applied DNA. “We are very encouraged
by our internal testing results to-date. 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 should be consistent
even against the capacity for this virus to mutate.”
Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at
Applied DNA and a 30-year veteran of the RNA-based molecular
diagnostics industry, stated, “We are pleased to be donating
state-of-the-art robotics and diagnostic devices and integrating
them into the Hospital’s facilities with the objective of yielding
throughputs of more than 500 patient samples per 8-hour shift, with
expected enhanced sensitivity and fewer false negatives. Our
scientists and the Hospital are collaborating closely to
dramatically increase throughput and sensitivity to better protect
first responders and patients, and to enable comprehensive testing
to the residents of Long Island.”
Yuhua Sun, Director of Applied Genomics at Applied DNA, and one
of the developers of the assay, stated, “By teaming with our
neighboring world-class hospital, we have mobilized with great
speed, not only in development of the diagnostic, but in the
continued exploration of viral loads in novel fluids and tissue
samples to learn more about the course of this disease and the
potential to improve diagnostics and therapeutics.”
The Agreement calls for Applied DNA to permanently contribute
equipment to the Hospital who will act as third-party validator of
the Company’s LineaCOVID-19 diagnostic, and for the Company to sell
diagnostics kits to the Hospital once the EUA has been granted by
FDA. Two forms of the diagnostic kit will be available to the
market, a “Basic Kit” designed for high-volume labs that can
provide some of the bulk ingredients usually found in large
reserves at labs routinely processing thousands of patient samples
per day, and a “Premium Kit” for labs that need everything at their
fingertips. In addition, the Company is working with its vendors to
provide a fully integrated monobloc platform that will allow
certified testing organizations to install turnkey operations in a
single order.
The Company plans to manufacture the positive controls (that
confirm the test is operating properly) using its LinearDNA™
platform used recently to deliver quantities of five candidate
linear DNA vaccines designed by its development partner in Italy,
Takis Biotech. The LineaCOVID-19 diagnostic leverages the Company’s
established knowhow regarding the Spike protein that is abundant on
the surface of the virus. The Company believes the abundance of
messenger RNA encoding for Spike is one of the factors that enhance
the sensitivity of the assay. A provisional patent application has
been filed with the United States Patent and Trademark Office
(USPTO) protecting the concepts on which the assay is based.
Applied DNA makes clear that while the Company expects to file
an EUA with the U.S. FDA by the end of the month, the U.S. FDA has
not yet approved the Company’s diagnostic and there is no guarantee
that any EUA will be approved.
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.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
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’.
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
or therapeutic 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 or equivalent foreign regulatory
agencies 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200420005982/en/
investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com program contact:
Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com, https://adnas.com/linearx
twitter: @APDN
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