- Subsidiary to Advance Commercial Development
of Diagnostic Tests for Virology, COVID-19, Oncology -
- Currently in Negotiations for First COVID-19
Testing Contracts; Anterior Nasal Swabs to Make Testing More
Accessible -
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 the
formation of a wholly-owned subsidiary, Applied DNA Clinical Labs,
LLC (“ADCL”), dedicated to the commercial development of its tests
in Virology, for the detection of COVID-19, and in Oncology, for
the detection and enumeration of invasive Circulating Tumor Cells
(iCTCs). With the formation of ADCL, the Company is executing on a
strategy to expand its market reach through value-added services
complementary to a growing portfolio of diagnostic assays
attractive to a broader number of qualified labs. ADCL allows
Applied DNA to be a direct beneficiary of its own diagnostics
development beyond the sales of kits to qualified laboratories, and
provides the clinical sampling framework necessary to obtain the
data required by State and Federal regulatory authorities to
develop and improve diagnostics and vaccines in the face of a
pandemic with rapidly shifting genetics and infectious
behavior.
In mid-May, Applied DNA received Emergency Use Authorization
(“EUA”) for a high sensitivity, high-throughput complex molecular
test for SARS-CoV-2, the coronavirus that causes COVID-19. The
Linea™ COVID-19 SARS-CoV-2 Assay Kit is a real-time polymerase
chain reaction (RT-PCR) test for the qualitative detection of
SARS-CoV-2 RNA in respiratory specimens. It provides a
high-throughput solution to help laboratories address the urgent
need for patient testing during the Coronavirus pandemic.
The Company also announced that the amendment of its EUA was
approved by FDA to include extraction and concentration of the
viral RNA by a magnetic method of nucleic acid extraction that
lends itself easily to high throughput scaling with robotics and
diversifies the two extraction methods already covered by the
existing EUA. A series of EUA amendments are planned to introduce
automation for increased throughput and accuracy, gain approval for
additional RNA extraction methods and PCR devices to expand the
footprint where our EUA assay can be used, develop point-of-care
testing and simplify sample acquisition from patients.
Commenting on the amendment, Dr. James Hayward, president and
CEO of Applied DNA, said, “We are extremely grateful to our
collaborators at Stony Brook University Hospital and to the FDA for
their guidance during the development and validation of our Linea
COVID-19 Assay Kit. Our goal is to service the COVID-19 patient
community and their families, and to facilitate the reopening of
universities and businesses with reliable, well-tested science. The
demand for COVID testing is diverse, from asymptomatic patients and
those in the early stages of disease, to the commercial imperative
to operate.”
The Company believes that as the demand for testing grows and
diversifies, the existing approval of the Company’s Linea COVID-19
Assay Kit for use with anterior nasal swabs will facilitate uptake
by certified testing labs. As opposed to nasopharyngeal swabs,
anterior nasal swabs only enter less than 1 inch into the nose,
allowing for sampling with minimal irritation or discomfort.
Additionally, anterior nasal swabs may be self-collected at a
healthcare location or collected by a healthcare worker.
Dr. Hayward continued, “With anterior nasal swabs, we believe
patient compliance is not an issue. This is a simple approach to
early testing, repetitive testing if begun early in infection, or
high-frequency testing, such as in schools, universities,
government office, and companies struggling with reopening. When
combined with our high-sensitivity and high-throughput Linea
COVID-19 Assay Kit, we believe the combined platform to be well
suited to combat both the healthcare and economic challenges of the
pandemic.”
ADCL, the Company’s new subsidiary was formed to enable clinical
testing of patient specimens using methods developed by the
Company’s research teams. Access to clinical specimens will also
facilitate more rapid development of improvements and new assays.
All of these continuous improvements are designed to help drive
sales to other approved testing labs.
ADCL was also formed to facilitate the use and development of
the Company’s Liquid Biopsy platform for detecting iCTCs in the
blood of cancer patients, far simpler and safer than surgical or
needle biopsies, and is already in use under contract in a Phase
III clinical trial of a promising drug for the treatment of Stage
IV pancreatic cancer. The trial involves 3,000 samples and the
quantification of metastatic cancer cells in the blood. Dr. Hayward
continued, “Eventually, with the utility of ADCL, we plan to seek
regulatory approval for our iCTC assay and add it to the tools used
in modern oncology to ensure better patient outcomes.”
The Company has obtained its Permanent Facility Identifier for
ADCL, has hired a New York State Licensed Clinical Laboratory
Director for Oncology and Virology and Certified Laboratory
Scientists, and has applied for a license from the New York State
Department of Health.
There can be no assurance that this license will be obtained, or
that FDA will maintain the Emergency Declaration that enabled the
EUA program for COVID-19 diagnostics. There can be no assurance
that the Company will obtain approved 510K status (or other
necessary regulatory approval) for its COVID-19 In Vitro
Diagnostics in the event that the Emergency Declaration is lifted.
In addition, the Company’s iCTC assay is currently limited to RUO
(Research Use Only), and there can be no assurance that the Company
will obtain the necessary regularly approval for its iCTC assay to
expand its use outside of RUO limitations.
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 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/20200709005245/en/
Investor contact: Sanjay M. Hurry, 212-838-3777 LHA
Investor Relations shurry@lhai.com
Program contact: Brian Viscount, Applied DNA,
631-240-8877 brian.viscount@adnas.com
Web: www.adnas.com
Twitter: @APDN
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