LineaRx Anticipates Expansion in Diagnostics Market via Follow-on Order and New Linear DNA Amplicons for Additional Assay

May 21, 2019 Off By BusinessWire

Shipments for Follow-on Order Under Existing Supply Agreement Will
Commence This Quarter

STONY BROOK, N.Y.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24apdn&src=ctag" target="_blank"gt;$apdnlt;/agt; lt;a href="https://twitter.com/hashtag/PCR?src=hash" target="_blank"gt;#PCRlt;/agt;–LineaRx, a wholly-owned subsidiary of Applied
DNA Sciences
, Inc. (NASDAQ: APDN), announced that it is in process
of designing new, custom amplicons for an existing customer in the in
vitro
diagnostics market. The diagnostic assay is expected to be
available and qualified in 2020, potentially resulting in increasing
revenue from an existing supply agreement.

The company currently receives annual orders for large-scale DNA from
this customer under a 5-year supply agreement executed in 2017. The
second annual purchase under the supply agreement was received earlier
this year, and shipments will commence this quarter and continue for the
following 3 quarters. This purchase order yields revenue in excess of
$500,000.

We believe linear DNA is ideal for diagnostic applications in that
modifications to the target amplicon made through the PCR process are
faster, more efficient and less costly than traditional chemical
derivatization. The molecular diagnostics market is projected to reach
$11.54 billion by 2023 from $7.10 billion in 2017 at a CAGR of 8.4%
(MarketsandMarkets.com; May 2018).

“The request for LineaRx to provide a new linear amplicon for a future
diagnostic assay is a testament to the merits of linear DNA as well as
our large-scale production capabilities,” said Brian Viscount, Director
of Product Management at LineaRx. “If the amplicon is qualified by our
customer, we expect recurring shipments under our supply agreement to
increase in calendar 2020.”

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s
deep expertise and experience in the design, manufacture and chemical
modification of DNA by large scale polymerase chain reaction (“PCR”).
Linear DNA is a form of DNA distinct from the circular form of DNA most
commonly produced in plasmids and grown in bacteria. Plasmids are
extrachromosomal DNA found in bacteria and are associated with the genes
for antibiotic resistance which are often exchanged between bacteria and
consequentially, are seen by many to embody a serious threat to global
health. In addition, many nucleic acid-based therapies also rely on
viral vectors for efficient transfection and expression of plasmid DNA.
These viral vectors carry additional nontrivial risks and are extremely
time consuming and expensive to manufacture

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.

Applied DNA makes life real and safe by providing innovative,
molecular-based technology solutions and services that can help protect
products, brands, entire supply chains, and intellectual property of
companies, governments and consumers from theft, counterfeiting, fraud
and diversion.

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Common stock listed on NASDAQ under the symbol APDN, and warrants are
listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of the Private Securities
Litigation 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 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,
ability to maintain its NASDAQ listing 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 18, 2018 and
our subsequent quarterly report on Form 10-Q filed on May 9, 2019, 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 to reflect the occurrence of
unanticipated events, unless otherwise required by law.

Contacts

investors: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777,
[email protected]
program:
Brian Viscount, 631-240-8877, [email protected]
web:
www.adnas.com,
www.linearxdna.com
twitter:
@APDN, @LineaRxDNA