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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.
Applied DNA Sciences, Inc. (NASDAQ: APDN) announced a partnership between its subsidiary, Applied DNA Clinical Laboratories, LLC (ADCL), and CLEARED4, a provider of health safety solutions. This partnership allows ADCL to resell subscriptions to CLEARED4's platform as part of its safeCircle pooled COVID-19 testing program. The integrated platform enhances COVID-19 safety protocols for businesses and schools. Dr. James A. Hayward, CEO of Applied DNA, emphasized the partnership’s role in scaling high-volume clients and improving infection detection. The CLEARED4 platform has issued over one million access passes, providing significant growth potential.
Applied DNA Sciences (NASDAQ: APDN) announced a strategic partnership between its subsidiary, Applied DNA Clinical Laboratories (ADCL), and CLEARED4 for COVID-19 surveillance testing. ADCL can resell CLEARED4 subscriptions as part of its safeCircle program. The integration enhances health safety protocols for clients, providing automated management of surveillance testing and timely results. CLEARED4 recently issued its one-millionth return-to-work Access Pass, demonstrating the platform's adoption in various sectors. This collaboration aims to expedite the safe return to work, schools, and public settings.
Applied DNA Sciences (APDN) reported financial results for the fiscal year and quarter ending September 30, 2020. Revenues fell 64% year-over-year to $1.9 million, primarily due to a drop in service and product revenues linked to the pandemic. The net loss applicable to common stockholders widened to $13 million, or $3.32 per share. The company has focused on developing COVID-19 related diagnostics and vaccines, securing partnerships and contracts, particularly with Stony Brook University Hospital. Cash reserves stood at $7.8 million at fiscal year-end, with ongoing efforts to address supply chain security.
Applied DNA Sciences, Inc. (NASDAQ: APDN) announced that its subsidiary, Applied DNA Clinical Laboratories (ADCL), has been awarded a COVID-19 surveillance testing program with Suffolk County, valued at up to $2 million. This 6-month contract may extend based on testing demand. The initiative will provide County employees access to efficient testing, crucial for managing the ongoing pandemic. ADCL's partnership with CLEARED4 enhances program automation and compliance with health regulations, while the safeCircle™ program uses pooled testing to identify infections rapidly.
Applied DNA Sciences (NASDAQ: APDN) reports increasing demand for its safeCircle pooled COVID-19 testing program, primarily from New York State schools adhering to the Winter COVID-19 Plan. New agreements could lead to a weekly testing population exceeding 5,000 individuals. The program aims to control infection rates in schools, requiring testing based on infection thresholds in designated micro-cluster zones. SafeCircle delivers results within 24 hours using its PCR-based technology.
Applied DNA Sciences, Inc. (NASDAQ: APDN) will release its fiscal 2020 fourth quarter financial results on December 17, 2020, after market close. A conference call is scheduled for 4:30 p.m. EST, with a live broadcast available online. The company provides solutions for supply chain security, anti-counterfeiting, and therapeutic drug candidates. Investors can access a recording of the call and subsequent webcasts on the company's website.
Applied DNA Sciences (NASDAQ: APDN) announced the expansion of its commercial activities through a multi-year Master Services Agreement with Nutrition21. Nutrition21 will utilize Applied DNA's CertainT® platform to secure its dietary supplement ingredients’ intellectual property. The agreement includes follow-on orders for the second year of commercial production, with shipments expected in the current fiscal quarter. Nutrition21 is the first to adopt this platform, which will enhance ingredient authenticity and address IP infringement, supporting both companies’ growth in the dietary supplements market.
Applied DNA Sciences (NASDAQ: APDN) announced its subsidiary, Applied DNA Clinical Laboratories, will implement its COVID-19 surveillance testing program, safeCircle™, for Stony Brook University’s basketball teams. This program will facilitate three testing sessions weekly, using the Linea™ COVID-19 Assay Kit, enhancing safety for athletes and staff.
Dr. James A. Hayward highlighted the significance of this partnership, aiming to set a testing model for other sports teams. The initiative represents a strategic expansion of ADCL's surveillance testing services amid ongoing COVID-19 challenges.
Applied DNA Sciences (NASDAQ: APDN) has received approvals from New York and U.S. agricultural departments for a veterinary trial of its LinearDNA COVID-19 vaccine candidate, aimed at domestic felines. This redesigned trial allows faster data collection and aims for a USDA APHIS conditional license for commercial sales after demonstrating safety and immunogenicity. The trial, beginning within 90 days, will recruit a smaller group of healthy felines to assess the vaccine’s effectiveness, responding to serious COVID-19 risks in animal reservoirs and potential spillover effects on human populations.
Applied DNA Sciences, Inc. (NASDAQ: APDN) will participate virtually in the Imperial Capital 2020 Security Investor Conference on December 3, 2020. CEO Dr. James A. Hayward is scheduled to present at 10:45 a.m. EST and will hold one-on-one meetings throughout the day. A webcast of the presentation will be archived within 24 hours on the company's Investor Relations page. Applied DNA specializes in PCR-based DNA manufacturing, focusing on supply chain security and anti-counterfeiting solutions.
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