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Applied DNA Sciences, Inc. (NASDAQ: APDN) is a biotechnology company pioneering advanced DNA-based technologies to safeguard assets and enhance industrial and healthcare applications. Headquartered in Stony Brook, NY, Applied DNA leverages Polymerase Chain Reaction (PCR) to produce and detect DNA and RNA, operating in three key segments: Therapeutic DNA Production Services, MDx Testing Services, and DNA Tagging and Security Products and Services.
In the Therapeutic DNA Production Services segment, Applied DNA produces synthetic DNA for nucleic acid-based therapeutics. With the acquisition of Spindle Biotech, the company has expanded its portfolio to include a proprietary RNA polymerase (RNAP) for mRNA therapeutics manufacturing. The recent contract with HDT Bio under the 'Project NextGen: Enabler' award aims to expedite mRNA vaccine production, highlighting the company's commitment to rapid-response medical solutions.
The MDx Testing Services segment, which includes clinical molecular diagnostic and genetic testing services, significantly contributes to the company's revenue. Applied DNA's innovative Linea™ IVT platform, designed to produce high-fidelity mRNA with reduced contamination, is a game-changer in molecular diagnostics.
Through the DNA Tagging and Security Products and Services segment, the company offers solutions under the brands Applied DNA Sciences, SigNature®, SigNature® T, fiberTyping, and SigNify®, providing robust anti-counterfeiting and product authentication services. These services are essential for supply chain security across various industries, including textiles and pharmaceuticals.
Recent achievements include closing a $12 million public offering to fund the development of DNA production services and the successful reverse stock split to comply with Nasdaq's minimum bid price requirements. Additionally, Applied DNA received a Notice of Allowance from the USPTO for a patent on its Linea™ RNAP, solidifying its intellectual property portfolio and extending patent protection into 2041.
Applied DNA remains dedicated to advancing DNA technology to meet the world’s evolving needs in healthcare, supply chain security, and beyond. For more information, visit their website at www.adnas.com and follow them on social media for the latest updates.
Applied DNA Sciences, Inc. (NASDAQ: APDN) and American & Efird (A&E) have announced the launch of A&E's INTEGRITY™ ECO100, a sustainable and secure sewing thread that integrates Applied DNA's CertainT® technology. This innovative product is made from 100% recycled fibers and allows brands to authenticate and validate their products throughout the supply chain. Celebrity designer Sara Caverley will utilize this thread in her footwear line, enhancing supply chain security. The collaboration aims to address the growing concerns of counterfeiting and ensure sustainability within the textile industry.
Applied DNA Sciences (NASDAQ: APDN) and Evvivax announced results from a study involving 11 vaccinated felines with their LinearDNA™ COVID-19 vaccine candidate. The study indicated neutralizing antibody production against SARS-CoV-2 variants B.1.1.7, P1, and B.1.526. While titers against B.1.1.7 showed no significant impact, reductions against P1 and B.1.526 were consistent with CDC data. The Company remains optimistic about the vaccine's effectiveness. A trial with mink is set to begin in August to further assess the vaccine's protective capabilities.
Applied DNA Sciences (NASDAQ: APDN) announced a contract with Camp Chateaugay for its safeCircle™ pooled COVID-19 surveillance testing. This contract emphasizes the company's focus on COVID-19 testing in niche markets, supporting the reopening of summer camps while minimizing virus spread. Testing will be conducted prior to and during the camp sessions using PCR technology, offering results within 24 hours. The success of this initiative could enhance Applied DNA's market presence in the public health sector as schools and camps seek reliable testing solutions.
Applied DNA Sciences (NASDAQ: APDN) has announced the successful technical validation of all seven Research Use Only (RUO) mutation detection assays in its Linea™ COVID-19 Selective Genomic Surveillance™ (SGS) Mutation Panel. Tested on 125 COVID-19 positive samples with 100% concordance against Whole Genome Sequencing results, the SGS Panel targets mutations designated as ‘Substitutions of Therapeutic Concern’ by the CDC. The Company plans to seek EUA-authorization for the panel, which is designed to enhance variant surveillance in the context of rising COVID-19 variants.
Applied DNA Sciences, Inc. (NASDAQ: APDN) clarifies its newly authorized asymptomatic serial screening indication for the Linea COVID-19 Assay Kit. While individual patients do not need personal prescriptions, a blanket prescription from a healthcare provider is required. The company’s subsidiary, Applied DNA Clinical Laboratories, will assist clients in obtaining these prescriptions to comply with regulatory standards. The Linea Assay Kit is not FDA approved but authorized for emergency use in specific testing conditions.
Applied DNA Sciences (NASDAQ: APDN) reported a significant 384% revenue growth year-over-year for the second fiscal quarter, driven by strong demand for its COVID-19 diagnostics. The company launched a clinical trial for a LinearDNA COVID-19 vaccine aimed at the veterinary market and established a recurring revenue stream through its CertainT platform. They also expanded their COVID-19 testing capabilities, allowing for enhanced monitoring of SARS-COV-2 mutations. Future strategies include pushing for Emergency Use Authorization for their Selective Genomic Surveillance Panel and expanding their therapeutic pipeline.
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.
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