STONY BROOK, NY - Applied DNA Sciences, Inc. (NASDAQ:APDN), a biotechnology firm specializing in PCR-based DNA technologies, has submitted a validation package to the New York State Department of Health (NYSDOH) for the expanded use of its Linea™ Mpox Virus 1.0 Assay. The submission, made through its subsidiary Applied DNA Clinical Labs, LLC (ADCL), aims to extend the assay's application to detect both clades I and II of the mpox virus.
The company's assay, which is not yet cleared or approved by the U.S. Food and Drug Administration, was previously authorized by NYSDOH in September 2022 for laboratory-developed testing of mpox clade II. The recent validation studies have confirmed that the assay's primers and probes are fully homologous with mpox clade I and clade Ib, the latter being the focus of the World Health Organization's declared public health emergency.
If NYSDOH approves the expansion, ADCL could offer clinical testing services for both clades of the mpox virus in its molecular diagnostics laboratory, which holds CLEP/CLIA certification. Such services would be available for samples originating from New York State and states recognizing New York's certification.
Applied DNA Sciences operates across three primary business markets, including the enzymatic production of synthetic DNA, molecular diagnostics, and DNA manufacture for supply chain security. The company's technologies leverage the polymerase chain reaction (PCR) for both DNA production and detection.
The timeline for the NYSDOH's review of the validation package is currently undetermined, and there is no guarantee of approval for the assay's use expansion. The company has cautioned that the forward-looking statements in their press release involve risks and uncertainties, and actual results could differ materially from those projected.
The information in this article is based on a press release statement from Applied DNA Sciences.
In other recent news, Applied DNA Sciences has been making strides in various sectors. The company announced plans to expand the use of its Linea™ Mpox Virus 1.0 Assay for detecting mpox Clade I, following a public health emergency declared by the World Health Organization. This expansion is currently undergoing validation studies and, if approved, would allow Applied DNA Clinical Labs to offer testing services for both mpox Clade I and II in New York State.
The company also failed to reach a quorum at a special meeting of stockholders, necessitating a subsequent meeting. Despite this setback, Applied DNA Sciences announced a partnership with Indus Group, integrating the CertainT® traceability platform into Indus's non-home textile products.
On the financial front, a public offering is expected to generate approximately $12 million in gross proceeds. However, H.C. Wainwright has lowered their price target for Applied DNA Sciences shares, maintaining a Buy rating.
These are the recent developments in the company's operations. 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.
InvestingPro Insights
Applied DNA Sciences, Inc. (NASDAQ:APDN) has shown a significant return over the last week, with a 1-week price total return of 133.75%. This surge comes amidst a backdrop of high price volatility, a characteristic trait for the stock, as noted by an InvestingPro Tip. The company's market capitalization stands at a modest $18.85 million, indicating its relatively small size within the biotechnology sector.
Despite the recent uptick in stock performance, analysts have concerns about the company's financial health. According to InvestingPro Data, Applied DNA Sciences has experienced a substantial revenue decline over the last twelve months, with a decrease of 78.96%. Moreover, the company is not profitable over the same period, with an operating income margin of -439.2%. These metrics suggest that while the company is making strides in its assay development, the financial aspect remains challenging.
On a more positive note, an InvestingPro Tip highlights that the company holds more cash than debt, which can be considered a stabilizing factor for its balance sheet. Additionally, liquid assets exceed short-term obligations, providing some level of assurance about the company's ability to meet its immediate financial responsibilities.
Investors interested in further insights can find additional InvestingPro Tips for Applied DNA Sciences, which cover a wide array of metrics and forecasts, including sales decline expectations, analyst profitability outlooks, and stock price performance over various time frames. There are currently 16 additional tips available on InvestingPro for those seeking a more comprehensive analysis.
For investors and stakeholders considering Applied DNA Sciences as part of their portfolio, these InvestingPro Insights offer a glimpse into the company's financial health and market performance, providing a data-driven perspective on its potential risks and opportunities.
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