STONY BROOK, N.Y.--(BUSINESS WIRE)--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.”
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.
Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.
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.