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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 (NASDAQ: APDN) announced the U.S. FDA has granted a re-issued Emergency Use Authorization (EUA) for its Linea™ COVID-19 Assay Kit, expanding its use for serial screening of asymptomatic individuals. This update allows testing without a prescription and enables individual result reporting. With CLIA certification for its Applied DNA Clinical Labs subsidiary, the company aims to support safer reopening strategies for schools and workplaces. The Assay Kit can now process thousands of samples daily, enhancing its market reach and testing capabilities.
Applied DNA Sciences (NASDAQ: APDN) announced that its subsidiary, Applied DNA Clinical Labs (ADCL), received CLIA certification for COVID-19 testing from the New York State Department of Health. This certification enables ADCL to conduct high-throughput diagnostic testing, enhancing its capacity to serve regional healthcare providers and boosting its safeCircle service's economics. The company aims to leverage this certification to broaden its COVID-19 testing and future diagnostic opportunities, with rapid turnaround times for results.
Applied DNA Sciences, Inc. (NASDAQ: APDN) plans to report its fiscal 2021 Q2 financial results on May 13, 2021, after market close. Management will discuss these results during a conference call at 4:30 p.m. ET. The LinearDNA platform, the company's proprietary PCR-based manufacturing system, is being commercialized for applications in diagnostics and drug development, including COVID-19 testing. The company will provide a telephonic replay of the call and will archive the webcast for up to one year.
Applied DNA Sciences (NASDAQ: APDN) announced significant results from a recent clinical trial of its LinearDNA vaccine candidate. The booster injection, administered 30 days post-prime vaccination, resulted in a more than 5-fold increase in SARS-CoV-2 neutralizing antibody levels among felines, surpassing previous predictions. The company plans to initiate a clinical trial for minks to tackle COVID-19 transmission risks. CEO Dr. James A. Hayward emphasized the promising implications of these results for both animal and human applications.
Applied DNA Sciences (NASDAQ: APDN) has secured a new firm fixed-price indefinite delivery contract valued at up to $1.04 million with the Defense Logistics Agency’s Product Test Center in Columbus, Ohio. This contract aims to support the DLA's counterfeit mitigation efforts by providing unique DNA marking services and quality control testing. This collaboration builds on their long-standing partnership since 2014, ensuring the integrity of products in critical sectors.
Applied DNA Sciences (NASDAQ: APDN) announced an amendment to its Master Services Agreement, doubling its maximum value for COVID-19 Assay Kits. The agreement ensures continued access for a customer’s surveillance testing program, with a purchase order for 16,000 tests supporting in-person graduation ceremonies in May 2021. CEO Dr. James A. Hayward emphasized the importance of proactive monitoring amid increasing vaccination rates and new virus variants. The Linea™ COVID-19 Assay Kit is FDA EUA authorized for specific respiratory specimens, aiding in the detection of SARS-CoV-2.
Applied DNA Sciences (NASDAQ: APDN) reported preliminary fiscal Q2 2021 revenues between $2.5 million and $2.7 million, a significant increase from $1.6 million in Q1 2021 and $552,000 in Q2 2020, driven by demand for its safeCircle™ COVID-19 testing program and Linea™ Assay Kit. The company also announced the full forgiveness of an $847,000 PPP loan, leaving it debt-free. The results are preliminary and await full financial disclosure in mid-May 2021.
Applied DNA Sciences (NASDAQ: APDN) announced positive preliminary results from a Phase I clinical trial of its LinearDNA™ COVID-19 vaccine candidate for domestic felines. Conducted in February, the trial showed that the vaccine was well-tolerated, producing high levels of SARS-CoV-2 neutralizing antibodies in all 11 participating cats. The company intends to extend the study until September 2021 to assess the durability of the immune response. Following these results, plans for Phase II trials are anticipated, focusing on vaccinated cats’ resistance to infection.
Applied DNA Sciences, Inc. (NASDAQ: APDN) announced an interview with CEO Dr. James A. Hayward on BBC’s Business Daily, focusing on traceability in cotton. The Company’s CertainT® platform authenticates materials in complex supply chains, having secured approximately 300 million pounds of North American cotton. CertainT ensures product integrity by marking cotton fibers with a unique identifier to combat illicit blending, including forced labor. The Company also commercializes its LinearDNA™ platform for diagnostics and drug development, alongside applications in supply chain security.
Applied DNA Sciences, Inc. (NASDAQ: APDN) and Northwell Health have established a pro bono Material Transfer Agreement for a real-time surveillance program to identify SARS-CoV-2 mutations. This program involves screening over 2,000 COVID-positive specimens using Applied DNA's Linea™ COVID-19 Assay Kit and Selective Genomic Surveillance™ Mutation Panel. Initial results show that approximately 80% of samples tested contain mutations. The data may aid in vaccine design and support clinical care improvements. The combination of these tools aims to optimize the use of limited next-generation sequencing resources.
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