Applied Dna Scie Stock Price, News & Analysis

Applied DNA Sciences (NASDAQ:APDN) has announced the expansion of its clinical testing services for Mpox (formerly monkeypox) to include both Clade I and Clade II detection. This launch follows interactions with regulatory bodies, including the New York State Department of Health (NYSDOH) and the FDA. The company's subsidiary, Applied DNA Clinical Labs (ADCL), will provide the testing service from its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y.

The Linea™ Mpox Virus 1.0 Assay was previously approved for Clade II detection by NYSDOH in September 2022. In August 2024, ADCL validated the assay's ability to detect Clade I, which is the subject of the WHO's recent public health emergency declaration. This expanded testing service aims to support New York and other states in responding to the growing mpox threat by improving testing accessibility.

Applied DNA Sciences (NASDAQ:APDN) has been awarded a subcontract by LRQA for a pilot isotopic testing program in Pakistan. The project, part of the Global Trace Protocol initiative, aims to reduce child and forced labor in global supply chains through traceability. Applied DNA will use its CertainT platform, which employs isotope testing, DNA tagging, and genomic testing for cotton textile traceability.

The project is funded by the U.S. Department of Labor with a total of $4 million in federal funds. Applied DNA will work with Isotech to conduct isotopic analysis of raw materials and products at key points in the cotton textile value chain. This initiative aligns with new import regulations requiring verification of cotton origin to ensure it doesn't come from high-risk sources.

Applied DNA Sciences (NASDAQ:APDN) has submitted a validation package to the New York State Department of Health (NYSDOH) to expand its Linea™ Mpox Virus 1.0 Assay to include both mpox clade I and clade II. The company's validation studies confirmed that the assay's primers and probe have 100% homology to mpox clade I and clade Ib, the latter being the subject of the WHO's recent public health emergency declaration.

The assay was previously approved for detecting mpox clade II in September 2022. If approved for clade I, Applied DNA could provide clinical testing services for both clades in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification.

Applied DNA Sciences (NASDAQ:APDN) has announced plans to expand the intended use of its Linea™ Mpox Virus 1.0 Assay to include detection of mpox Clade I, following the WHO's recent declaration of a public health emergency. The company's internal data suggests the assay can detect mpox Clade I's genetic sequence, and validation studies are underway to support a filing with the New York State Department of Health (NYSDOH).

If approved, Applied DNA could offer clinical testing services for both mpox Clade I and Clade II in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification. The assay is currently approved as a laboratory-developed test for mpox Clade II detection. The company emphasizes that the timing and approval of the NYSDOH filing are uncertain.

Applied DNA Sciences (NASDAQ:APDN) announced its Q3 FY2024 financial results, revealing a revenue decline to $798,000 from $2.9 million in Q3 FY2023. The decrease was primarily due to the conclusion of a COVID-19 testing contract. Gross profit fell to $245,000 with a 31% margin, down from $1.3 million and 44% margin in the prior year. Operating expenses decreased to $3.6 million, while the operating loss increased to $3.3 million. The company ended the quarter with $10.4 million in cash, bolstered by a recent $10.5 million public offering.

Despite financial challenges, Applied DNA reported progress in its business segments. The company is on track to launch a GMP facility for Linea™ IVT templates, secured new customers for its Linea™ IVT platform, and established a potential $25 million annual revenue opportunity for its TR8™ PGx testing service. The company also entered a multi-year commercialization agreement with Indus Group for its CertainT® platform.

Applied DNA Sciences, Inc. (NASDAQ:APDN) has announced the release of its third quarter fiscal 2024 financial results on Thursday, August 8, 2024, after market close. The company will host a conference call for analysts and investors at 4:30 p.m. ET on the same day to discuss the financial results and recent accomplishments. Domestic callers can dial toll-free at 844-887-9402, while international callers can use 412-317-6798. A live webcast will be available, and a slide presentation will be embedded in the webcast. A telephonic replay of the conference call will be accessible until August 15, with replay access codes provided for different regions.

Applied DNA Sciences (NASDAQ: APDN) will showcase its Linea™ IVT platform at the 4th Annual mRNA-based Therapeutics Summit from July 29-31, 2024, in Boston. The Linea IVT platform integrates an enzymatically produced DNA template with a next-gen RNA polymerase, aiming to enhance mRNA production by reducing double-stranded RNA (dsRNA) contamination.

The poster titled Reduction of dsRNA Contamination in High-Yield mRNA Production, authored by Yuhua Sun, Huan Dong, Qiang Zhao, Finly Philip, Clay Shorrock, Aaron Chung, and James A. Hayward, will be presented on July 30, 2024, from 3:45 - 4:30 p.m. (local time). According to Clay Shorrock, executive director at LineaRx, reducing dsRNA is important for efficient mRNA expression and regulatory compliance. The platform promises simplified workflows, lower purification costs, and faster production times, supporting the development of mRNA therapeutics, vaccines, and personalized therapies.

Applied DNA Sciences (NASDAQ:APDN) will present its Linea™ IVT platform at the 4th Annual mRNA-based Therapeutics Summit in Boston, July 29-31, 2024. The platform combines an enzymatically produced DNA template with a next-generation RNA polymerase to manufacture mRNA with reduced double-stranded RNA (dsRNA) contamination. This addresses a key industry challenge without sacrificing yields.

The poster, titled 'Reduction of dsRNA Contamination in High-Yield mRNA Production,' will be presented on July 30. Clay Shorrock, executive director of business development at LineaRx, highlighted that dsRNA reduction is a top priority for therapy developers and CDMOs to ensure efficient mRNA expression, reduce immunogenicity risks, and meet regulatory compliance. The Linea IVT platform offers a fully enzymatic solution that could support the development of transformative mRNA-based medicines, including therapeutics, vaccines, and personalized therapies.

Applied DNA Sciences (NASDAQ:APDN) has signed a five-year license and commercialization agreement with Indus Group for its CertainT traceability platform. The agreement covers non-home, cotton-based products from Indus facilities in Pakistan, Egypt, and Jordan. Indus, which consumes about 450 million pounds of cotton annually, will have exclusive use of the platform in these countries and non-exclusive use elsewhere.

The CertainT platform uses forensic, multiple-proof-point evidence for source and authenticity verification of materials throughout global supply chains. This marks CertainT's first large-scale deployment catalyzed by the Uyghur Forced Labor Prevention Act (UFLPA). The agreement is expected to reduce revenue lumpiness in Applied DNA's segment by enabling year-round cotton tagging at Indus's spinners.