- Announces Completion of Initial New York
State Department of Health Inspection of Clinical Lab Subsidiary
-
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, pre-clinical
nucleic acid-based therapeutic drug candidates, supply chain
security, anti-counterfeiting, and anti-theft technology, announced
that Applied DNA Clinical Laboratories, LLC (“ADCL”), its
wholly-owned subsidiary, has secured COVID-19 surveillance testing
contracts under its testing-as-a-service (“TaaS”) offering that are
estimated to generate more than $1.0 million in total annualized
revenue beginning October 1, 2020. The Company’s surveillance
testing revenue expectation is contingent on full-term
participation by TaaS customers, including:
- Private schools based in Long-Island, N.Y., including Harbor
Country Day School. Education customers comprise the bulk of the
Company’s current testing volume;
- Several New York State-based small enterprises and private
clients.
Unlike diagnostic testing, which looks for the occurrence of
COVID-19 at the individual level, surveillance testing looks for
infection within a defined population or community and can be used
for making health management decisions at the population level.
Surveillance testing does not require a prescription. In
surveillance testing, pooled test results are returned to the
sponsoring organization in the aggregate, not directly to the
individual, and may be performed without CLIA certification.
Concurrently, the Company is executing on a sales and marketing
strategy to build a pipeline of LineaTM COVID-19 Diagnostic Assay
Kit (“Assay Kit”) and TaaS opportunities through:
- Outreach to independent and hospital laboratories in COVID-19
hotspots nationally and regionally to offer an additional
diagnostic kit supply line;
- Outreach to local laboratories to construct a reference
laboratory relationship for overflow testing;
- Deployment of testing at Stony Brook University in accordance
with a recently signed Master Services Agreement.
“Our capacity to perform COVID-19 surveillance testing is
grounded in self-collection saliva kits and anterior nasal swab
kits that are intuitive to use, a highly sensitive PCR-based Assay
Kit that can detect as little as one copy of the SARS-CoV-2 genome
per microliter in an individual saliva sample, and a
high-throughput surveillance testing lab that can return testing
results within 24 hours and often on the same day as sampling. When
deployed as part of a consistent and ongoing surveillance testing
regime, we believe our Assay Kit can help our clients to detect the
virus before its median incubation time of 4 to 5 days from
exposure to symptom-onset1. Being able to identify infections early
and in a cost-efficient and rapid manner is how surveillance
testing gets workers back to work and students back to school,”
said Dr. James A. Hayward, president and CEO.
“We are beginning to see the first fruits of our Assay Kit and
TaaS sales and marketing efforts translate into revenue,” concluded
Dr. Hayward. “As we continue to expand our sales pipeline of Assay
Kit and surveillance testing opportunities, we believe these
efforts can serve as a potentially material driver of our growth
supplemented by diagnostic customer testing upon receipt of
CLEP-CLIA certification.”
Update on CLEP-CLIA
Certification
Separately, the Company announced that the State of New York
Department of Health (DoH) completed the initial inspection of ADCL
on October 7, 2020. Inspection reports are generally filed by the
DoH within 4 to 6 weeks of the inspection date. A passing grade
would confer onto ADCL DoH’s Clinical Laboratory Program (CLEP)
certification under which ADCL can function as a certified clinical
lab. CLEP-approved clinical laboratories located in New York State
meet Clinical Laboratory Improvement Amendments of 1988 (CLIA)
proficiency testing and accreditation requirements that would
enable ADCL to receive patient samples collected nationally for
testing. A failing grade would require ADCL to remediate
deficiencies prior to any re-inspection request. The Company offers
no timetable for receipt of CLEP-CLIA certifications at this
time.
Use of LineaTM COVID-19 Assay Kit for
Surveillance Testing
Pursuant to current guidances from the CDC, FDA, and CMS,
Applied DNA’s Assay Kit can be marketed for surveillance and
research use. Applied DNA has internally validated the Assay Kit
for surveillance testing using pooled saliva samples for up to five
samples. The Company notes that the use of pooled saliva samples is
for surveillance testing only and has not been authorized under the
Company’s EUA for the Assay Kit. CLEP certification would enable
ADCL to perform the disambiguation of any positive pools identified
in the Company’s surveillance testing program.
1 “Interim Clinical
Guidance for Management of Patients with Confirmed Coronavirus
Disease (COVID-19)” Centers for Disease Control and Prevention, 10
Sept. 2020,
https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html
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.
About the LineaTM COVID-19 Assay Kit
The LineaTM COVID-19 Assay Kit is authorized by FDA EUA for the
qualitative detection of nucleic acid from SARS-CoV-2 in
respiratory specimens, including anterior nasal swabs,
self-collected at a healthcare location or collected by a
healthcare worker, and nasopharyngeal and oropharyngeal swabs,
mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal
aspirates, and bronchoalveolar lavage (BAL) specimens collected by
a healthcare worker from individuals who are suspected of COVID-19
by their healthcare provider.
The scope of the LineaTM COVID-19 Assay Kit EUA, as amended, is
expressly limited to use consistent with the Instructions for Use
by authorized laboratories, certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) to perform high complexity
tests. The EUA will be effective until the declaration that
circumstances exist justifying the authorization of the emergency
use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 is terminated or until the EUA’s prior termination or
revocation. The diagnostic kit has not been FDA cleared or
approved, and the EUA’s limited authorization is only for the
detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens.
The Company is offering surveillance testing in compliance
with current CDC, FDA, and CMS guidances. The use of pooled saliva
sampling for surveillance testing, which has been internally
validated by the Company in compliance with current surveillance
testing guidances, is not included in the Company’s EUA
authorization for the LineaTM COVID-19 Assay Kit.
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, limited market acceptance,
the uncertainties inherent in research and development, future
clinical data and analysis, including whether any of Applied DNA’s
or its partner’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 and/or the New York State Department of Health,
the unknown limited duration of any Emergency Use Authorization
(EUA) approval from U.S. FDA, changes in guidances promulgated by
the CDC, FDA and/or CMS, 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, May 14,
2020 and August 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201012005192/en/
Investor contact: Sanjay M. Hurry, Applied DNA Sciences,
917-733-5573, sanjay.hurry@adnas.com
Program contact: Mike Munzer, Applied DNA Sciences,
631-240-8800, mike.munzer@adnas.com
Web: www.adnas.com
Twitter: @APDN
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