STONY BROOK, NY - Applied DNA Sciences, Inc. (NASDAQ:APDN), a company specializing in PCR-based DNA technologies, announced today that its subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has broadened its clinical testing services to detect both Clade I and Clade II of the Mpox virus. This development follows ADCL's engagement with regulatory bodies such as the New York State Department of Health (NYSDOH) and the U.S. Food and Drug Administration (FDA).
The company's president and CEO, Dr. James A. Hayward, expressed that the expanded testing services are set to enhance New York and other states' capacity to address the Mpox threat by facilitating better access to diagnostic tools necessary for controlling the virus's spread.
ADCL's Linea™ Mpox Virus 1.0 Assay, which was already approved by the NYSDOH in September 2022 for detecting Mpox clade II, has undergone additional validation testing in August 2024. These tests confirmed the assay's capability to also identify the genetic sequence of Mpox Clade I, which the World Health Organization declared a public health emergency of international concern on August 14, 2024. The testing will be conducted at ADCL's molecular diagnostics laboratory in Stony Brook, N.Y, which is permitted by NYSDOH CLEP and certified by the Clinical Laboratory Improvement Amendments (CLIA) for high-complexity testing.
While the Linea Mpox Virus 1.0 Assay is intended for clinical purposes, it has not been cleared or approved by the FDA. The assay’s performance characteristics were determined by ADCL.
Applied DNA Sciences operates in various sectors, including the production and detection of synthetic DNA for therapeutics, molecular diagnostics, and DNA manufacturing for supply chain security services.
The information provided is based on a press release statement and includes forward-looking statements subject to risks and uncertainties. These statements are not guarantees of future performance, and actual results could differ materially from those projected. Factors that could cause differences include demand for Mpox testing, regulatory changes, raw material supply disruptions, and varying infection rates. Further details on these risks are available in Applied DNA's SEC filings.
The company has a history of net losses and limited financial resources, and it does not undertake any obligation to publicly update forward-looking statements.
In other recent news, Applied DNA Sciences has been granted a subcontract to support cotton traceability in Pakistan, a project funded by the U.S. Department of Labor and aimed at reducing child and forced labor in global supply chains. The company has also submitted a validation package to the New York State Department of Health for the expanded use of its Linea™ Mpox Virus 1.0 Assay to detect both clades I and II of the mpox virus. Despite a failure to reach a quorum at a special meeting of stockholders, Applied DNA has announced a partnership with Indus Group, integrating the CertainT® traceability platform into Indus's non-home textile products. Additionally, a public offering is expected to generate approximately $12 million in gross proceeds. Analyst firm H.C. Wainwright has lowered their price target for Applied DNA Sciences shares, maintaining a Buy rating. The company has also received approval from the New York State Department of Health for its pharmacogenomic testing service, TR8™, and plans to implement a reverse stock split to comply with Nasdaq's listing rules. These are the recent developments in the company's operations.
InvestingPro Insights
Applied DNA Sciences, Inc. (NASDAQ:APDN) has made strides in expanding its diagnostic capabilities, yet the company's financial health and market performance provide a nuanced picture for investors. According to the latest data from InvestingPro, Applied DNA Sciences holds a market capitalization of approximately $13.18 million. This relatively small market cap reflects the company's position within the competitive biotech sector.
InvestingPro metrics indicate that the company's revenue for the last twelve months as of Q3 2024 stands at $3.4 million, with a notable decline of 78.96% from the previous period. This significant decrease in revenue growth raises concerns about the company's financial trajectory. Furthermore, with a gross profit margin of 25.04%, Applied DNA Sciences demonstrates its ability to retain a quarter of its revenue as gross profit, a critical factor for its operational sustainability.
However, the company's financial challenges are also evident. Applied DNA Sciences is not currently profitable, with an operating income margin of -439.2%, indicating expenses far exceed revenues. This is further underscored by two key InvestingPro Tips: the company is quickly burning through its cash, and analysts do not anticipate profitability this year. These insights suggest that while the company is advancing in its clinical offerings, financial prudence and strategic management will be crucial for its future stability.
Investors considering Applied DNA Sciences should also be aware of the stock's high price volatility and its significant price decline over the past year. Yet, it's noteworthy that the company has seen a strong return over the last month, which may interest those looking for short-term opportunities.
For a more detailed analysis and additional insights, investors can explore the full list of 15 InvestingPro Tips for Applied DNA Sciences at InvestingPro.
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