Applied DNA Subsidiary LineaRx Provides Cost and Quality Advantages to Technogenetics Diagnostic Solutions

The purified, PCR-produced DNA is custom-made for Technogenetics and is used to prepare the basic component responsible for the diagnostic specificity of two kits: one kit is used for the determination of dsDNA autoantibodies and the other for an ANA (Anti-Nuclear Antibodies) Screen.

“During the kits’ development, the Technogenetics R&D laboratories tested several polynucleotides. Only the linear DNA from LineaRx demonstrated high lot-to-lot reproducibility and the correct sequence of the polynucleotide,” said Clara Pasini, R&D - Clinical Affairs Consultant at Technogenetics. “These attributes improve the efficiency of our quality control for incoming raw materials and improve the overall quality, accuracy and reproducibility of our products.”

The Technogenetics kits employing linear DNA, assist in the laboratory diagnosis of systemic rheumatic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren’s Syndrome (SS), progressive systemic sclerosis (PSS), dermatomyositis/polymyositis (DM/PM) and/or mixed connective tissue disease (MCTD).

In particular, the anti-dsDNA antibodies have high diagnostic value as autoantibody markers in patients with SLE, and for this reason they are included in the SLE classification criteria of the American College of Rheumatology. [1] Their prevalence in SLE varies from 40 to 80% according to case study and assay method. Besides its diagnostic function, the anti-dsDNA assay can play an important role in monitoring the progression of SLE, especially in patients with lupus nephritis. This is closely associated with the pathogenetic role of the antibodies: exacerbation of SLE is preceded by a constant and progressive increase of the anti-dsDNA antibodies, followed by a sharp decline at the moment of clinical recrudescence, which is justified by glomerular deposition of high-avidity DNA/anti-dsDNA immune complexes. [2] For this reason, this assay is widely used in the diagnosis and monitoring of SLE.

The molecular diagnostics market is projected to reach USD 11.54 billion by 2023 from USD 7.10 billion in 2017 at a CAGR of 8.4%. (MarketsandMarkets.com; May 2018).

“DNA produced by LineaRx is used by a number of customers who have a diagnostic solution in the market. These customers use our linear DNA as a critical part of their assay or as positive control for device calibration,” said Brian Viscount, Director of Product Management at Applied DNA. “Last year we shipped multiple grams of our linear DNA to our diagnostic customers. Linear DNA enables our diagnostic customers to minimize Quality Control costs and to ensure product reliability and consistency across their customer base. We are actively marketing to expand this business through new account acquisition and increasing our value add to existing customers.”

1. M Hochberg. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40: 1725.
2. AJG Swaak, R Smeenk. Detection of anti-dsDNA as a diagnostic tool: a prospective study in 441 non-systemic lupus erythematosus (SLE ) patients with anti-dsDNA antibody (anti-dsDNA). Am Rheum Dis 1985; 44: 245-51.

About Technogenetics

Technogenetics is an innovative company working in the immunodiagnostics and molecular genetics fields. Technogenetics acts as a point of reference in the medical and scientific communities, developing and providing efficient, effective, environmentally friendly diagnostic solutions and products to improve prevention, diagnosis and treatment of several diseases.

Thanks to its high and specific know-how in the IVD (in vitro diagnostics) field, Technogenetics has provided an increased boost to research activities and manufacturing capabilities.

Technogenetics operates in international markets with strong partners. Due to the cooperation with international partners and an internal sales force, Technogenetics is well-known and appreciated in the industry being focused to customer needs and able to propose innovative solutions and avant-garde products.

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 DNA mass production for diagnostics and therapeutics.

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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The Company’s common stock is listed on NASDAQ under the symbol APDN, and its 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 our history of 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, 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 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN 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.

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