Large-Scale Production of Linear DNA Shows the Best Lot-To-Lot Reproducibility and Sequence Accuracy for Kits Targeting Autoimmunity and Infectious Diseases
STONY BROOK, NY. November 7, 2018 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA”), the leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx” or the “Company”) has been providing linear DNA to Technogenetics (Shanghai Kehua Bio-Engineering Co., Ltd-KHB group) that produces and sells kits to detect autoimmunity and infectious diseases.
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.  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.  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.”
M Hochberg. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40: 1725.
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.
.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.
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.
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