- Expansion of Population-Scale Molecular
Diagnostics Menu Positions ADCL Subsidiary for Long-Term Growth
-
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in PCR-based DNA technologies, today announced that its
wholly-owned clinical laboratory subsidiary, Applied DNA Clinical
Labs, LLC (ADCL), has submitted a validation package to the New
York State Department of Health (NYSDOH) in support of approval for
a pharmacogenomics (PGx) assay as a NYSDOH laboratory-developed
test (LDT). If approved by NYSDOH, the LDT test will be used by
ADCL to power its population-scale PGx testing services.
ADCL’s PGx testing will focus on population-scale testing that
is expected to be accretive to ADCL’s margin profile. ADCL’s
commercial strategy is centered on the direct-to-enterprise and
self-insured health markets that do not require ADCL to seek
third-party reimbursement or engage in individual patient billing.
In advance of initiating its PGx testing services, the Company’s
sales outreach has targeted regional health systems and large,
self-insured entities in its New York operating area and in States
that recognize New York’s CLEP/CLIA certification.
PGx testing is a data-driven approach that relates an
individual’s genetic factors to variable responses to prescription
drugs. ADCL’s PGx assay interrogates 120 targets across 37 genes
relevant to a broad range of common drugs, including cardiac, pain
management, cancer, and mental health therapies. PGx testing yields
actionable information to empower healthcare providers to deliver
precision medicine to their patients through personalized drug
prescribing and dosing.
Recently published studies have shown that population-scale PGx
testing can significantly reduce overall population healthcare
costs, reduce adverse drug events, and increase population
wellbeing1,2. These benefits can result in significant cost savings
to large entities and self-insured employers, the latter accounting
for approximately 65% of all U.S. employers in 20223.
“PGx testing is a logical first step into the promising field of
personalized medicine that brings together ADCL’s demonstrated
capacity for population-scale testing and PGx’s proven benefits to
the individual. When applied to large populations, we believe that
the combination will generate significant healthcare cost
reductions for enterprises and overall wellness benefits to
employees,” stated Dr. James A. Hayward, president and CEO of
Applied DNA Sciences. “Given PGx testing’s attractive margin
profile and ongoing conversations with prospective customers, we
view this first genetic assay as the basis for a long-term,
profitable testing service.”
Footnotes:
1 Jarvis, J. P., Peter, A. P., Keogh, M., Baldasare, V.,
Beanland, G. M., Wilkerson, Z. T., Kradel, S., & Shaman, J. A.
(2022). Real-world impact of a pharmacogenomics-enriched
comprehensive medication management program. Journal of
Personalized Medicine, 12(3), 421.
https://doi.org/10.3390/jpm12030421
2 Jesse J Swen, Cathelijne H van der Wouden, et al., A
12-gene pharmacogenetic panel to prevent adverse drug reactions: an
open-label, multicentre, controlled, cluster-randomised crossover
implementation study, The Lancet, Volume 401, Issue 10374, 2023,
pages 247-356. https://doi.org/10.1016/S0140-6736(22)01841-4.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01841-4/fulltext
3
https://www.statista.com/statistics/985324/self-funded-health-insurance-covered-workers/
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing
technologies to produce and detect deoxyribonucleic acid (“DNA”).
Using PCR to enable both the production and detection of DNA, we
operate in three primary business markets: (i) the manufacture of
DNA for use in nucleic acid-based therapeutics; (ii) the detection
of DNA in molecular diagnostics testing services; and (iii) the
manufacture and detection of DNA for industrial supply chain
security services.
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 the ticker
symbol ‘APDN,’ and its publicly traded warrants are listed on OTC
under the 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 its history of
net losses, limited financial resources, unknown future demand for
its biotherapeutics and diagnostics/genetics products and services
and the unknown amount of revenues and profits that will result
from any diagnostic or genetic testing contracts. Further, the
uncertainties inherent in research and development, future data and
analysis, and applications to regulatory bodies including whether
any of Applied DNA's current or future diagnostic and/or genetic
testing candidates will advance further in the research and/or
validation process or receiving authorization, clearance or
approval from the FDA, equivalent foreign regulatory agencies
and/or the NYSDOH, and whether and when, if at all, they will
receive final authorization, clearance or approval from the FDA,
equivalent foreign regulatory agencies and/or NYSDOH, the unknown
outcome of any applications or requests to FDA, equivalent foreign
regulatory agencies and/or the NYSDOH and various other factors
detailed from time to time in Applied DNA’s SEC reports and
filings, including its Annual Report on Form 10-K filed on December
14, 2022 as amended, its form 10-Q filed on February 9, 2023 and
other reports it files 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/20230321005976/en/
Corporate: Investor Relations Contact: Sanjay M.
Hurry, 917-733-5573, sanjay.hurry@adnas.com ADCL Program
Contact: Mike Munzer, 631-204-8814, mike.munzer@adnas.com
Web: www.adnas.com Twitter: @APDN
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Apr 2024 to May 2024
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From May 2023 to May 2024