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Overview
Applied DNA Sciences is a biotechnology company specializing in the enzymatic production and detection of synthetic deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) using advanced polymerase chain reaction (PCR) technologies. The company caters to multiple industries with a focus on nucleic acid-based therapeutics, molecular diagnostics, and forensic authentication to secure supply chains and protect intellectual property.
Core Business Segments
- Therapeutic DNA Production Services: Leveraging its proprietary Linea DNA platform, the company produces highly pure, scalable synthetic DNA that serves as a critical component in the manufacture of nucleic acid-based therapies, including mRNA therapeutics and DNA vaccines.
- MDx Testing Services: Through its molecular diagnostics (MDx) capabilities, Applied DNA Sciences performs advanced genetic and clinical laboratory testing. These services are directed at ensuring accurate diagnostic results and personalized treatment strategies, contributing to better patient outcomes.
- DNA Tagging and Security Products & Services: With innovative solutions like the CertainT platform, the company provides botanical-DNA based security and authentication technology. This system verifies the authenticity of materials in supply chains, thereby protecting brands, assets, and intellectual property from fraud, counterfeiting, and diversion.
Key Technologies and Platforms
Applied DNA Sciences stands out due to its integration of state-of-the-art biochemical processes and robust forensic methodologies. Its proprietary platforms include:
- Linea DNA: A cell-free, enzymatic production platform that generates high-fidelity synthetic DNA constructs with versatile applications in therapeutics and diagnostics.
- Linea IVT: This innovative platform pairs DNA IVT templates with a next-generation RNA polymerase, streamlining mRNA production while reducing double-stranded RNA contamination, a critical factor in ensuring product purity and regulatory compliance.
- CertainT: A comprehensive traceability solution that integrates isotopic testing, DNA tagging, and genomic analyses. This platform delivers multiple key proof points to verify the origin and authenticity of raw materials and finished products, particularly within the textile industry.
Market Position and Strategic Significance
By combining advanced manufacturing protocols with forensic traceability techniques, Applied DNA Sciences provides robust solutions that address critical challenges across various sectors. The company's technologies not only enhance the efficiency of nucleic acid-based therapeutics production but also fortify supply chains against counterfeiting and fraud. Its unique approach of integrating multiple layers of verification underlines its commitment to quality, security, and innovation.
Operational Excellence and Industry Impact
The firm's reliance on enzymatic PCR-based processes sets it apart as an expert in producing synthetic DNA with high scalability and fidelity. This technical proficiency supports a diverse customer base, including pharmaceutical developers, diagnostic laboratories, governmental agencies, and global manufacturers who demand reliable, secure, and innovative solutions. Furthermore, by continuously refining its production and testing methodologies, the company demonstrates a strong dedication to research and development, ensuring its processes remain at the forefront of biotechnology innovation.
Conclusion
Overall, Applied DNA Sciences delivers comprehensive solutions that span from the production of synthetic DNA for advanced therapeutics to the forensic authentication of products in global supply chains. Its balanced focus on clinical, industrial, and security applications positions the company as a multifaceted player in the biotechnology sector, dedicated to enhancing product integrity and operational efficiency through innovative, proof-based technologies.
TruTrace Technologies (CSE: TTT) has signed a definitive alliance with Applied DNA Sciences (NASDAQ: APDN) to develop a comprehensive cannabis product validation platform. Combining TruTrace’s StrainSecure™ with Applied DNA’s CertainT® system enables enhanced product authentication and end-to-end traceability through blockchain and molecular tagging. The agreement facilitates mutual referrals and technology integration, enhancing the security of cannabis supply chains. Notably, Shoppers Drug Mart employs TruTrace's platform for its medical cannabis program, underscoring its industry relevance.
Applied DNA Sciences (NASDAQ: APDN) and TruTrace Technologies (CSE: TTT) have formed a strategic alliance to implement a blockchain-based solution for the cannabis industry. The agreement integrates Applied DNA’s CertainT platform with TruTrace’s StrainSecure™ platform, enhancing product validation and authentication. This collaboration aims to ensure end-to-end traceability and transparency, offering significant advantages to consumers and brands against counterfeiting. The partnership also establishes a mutual referral system to capitalize on joint opportunities.
Applied DNA Sciences, Inc. (NASDAQ: APDN) has promoted Judith Murrah from Chief Information Officer to Chief Operating Officer. This position formalizes her growing responsibilities in customer relations, QA oversight, and operations management. Ms. Murrah has played a crucial role in expanding COVID-19 testing and implementing Current Good Manufacturing Practices at LineaRx. With a strong background in technology leadership, Ms. Murrah aims to support the company’s growth in nucleic acid-based therapeutics using its PCR-based LinearDNA™ platform.
Applied DNA Sciences (NASDAQ: APDN) announced that its Linea™ COVID-19 Assay Kit successfully identified COVID-19 variants, including the U.K. variant B.1.1.7, via S-gene dropout. This detection is part of the Company’s safeCircle™ pooled surveillance testing service. The Assay Kit received FDA EUA for identifying SARS-CoV-2 in various respiratory specimens. The Company emphasizes the importance of utilizing its Assay Kit for early detection of new variants to aid in controlling COVID-19 spread. The testing method showcases a multi-target design, maintaining sensitivity even for variant-infected samples.
Applied DNA Sciences, Inc. (NASDAQ:APDN) reports a 158% increase in daily average tests for its safeCircle™ pooled surveillance testing service in January 2021 compared to December 2020, due to expanding contracts and new clients.
The Company plans to scale up production of its Linea™ COVID-19 Assay Kit in response to increased demand and recent FDA alerts highlighting its diagnostic capabilities for SARS-CoV-2 mutations. With 33 clients, including educational institutions and local governments, Applied DNA expects to enhance revenue through its CLEARED4 partnership, streamlining COVID-19 testing solutions.
Applied DNA Sciences, Inc. (NASDAQ: APDN) has closed a registered direct offering of 1,810,000 shares of common stock at $8.30 per share, yielding approximately $15 million in gross proceeds. The funds will be used for general corporate purposes, including working capital and advancing the LinearDNA™ manufacturing platform. Roth Capital Partners acted as the sole placement agent for the offering, which was conducted under a shelf registration statement previously filed with the SEC.
Applied DNA Sciences, Inc. (NASDAQ: APDN) has announced a registered direct offering of 1,810,000 shares at $8.30 each, totaling approximately $15 million in gross proceeds. The offering, expected to close on January 13, 2021, aims to support general corporate needs, including research and development and promoting its LinearDNA™ platform. Roth Capital Partners acted as the sole placement agent for this transaction, conducted under a previously effective registration statement.
Applied DNA Sciences announced that its Linea™ COVID-19 Assay Kit is one of only two tests recognized by the FDA for identifying specific SARS-CoV-2 mutations, including the U.K. variant B.1.1.7. This distinction highlights the Assay Kit's multi-target design, which maintains sensitivity despite some genetic variations. The FDA's safety communication indicates that this kit can assist in detecting and tracking COVID-19 variants more effectively. The Assay Kit is authorized for use in various respiratory specimens, aiding public health efforts against COVID-19.
Applied DNA Sciences, Inc. (NASDAQ: APDN) announced that Dr. James A. Hayward will participate in a fireside chat at the virtual H.C. Wainwright BIOCONNECT 2021 Conference, scheduled for January 11-14, 2021. This event will be hosted by Yi Chen, Managing Director of H.C. Wainwright Equity Research. The chat will be available on-demand starting January 11 at 6:00 a.m. EST on the company's website, with an archived replay accessible for 90 days thereafter.
Applied DNA specializes in molecular technologies focused on supply chain security and anti-counterfeiting.
Applied DNA Sciences (NASDAQ: APDN) anticipates fiscal Q1 2021 revenues between $1.3 million and $1.6 million, significantly up from $314,000 in Q4 2020. This growth is attributed to the safeCircle™ COVID-19 testing program and sales of the Linea™ COVID-19 Assay Kit. The company reports strong client acquisition and ongoing demand, including a recent contract with Suffolk County worth up to $2 million. Full financial results are expected in mid-February.
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