STONY BROOK, NY - Applied DNA Sciences, Inc. (NASDAQ:APDN), a company specializing in PCR-based DNA technologies, announced today that its pharmacogenomic (PGx) testing service, known as TR8™, has received approval from the New York State Department of Health (NYSDOH). The approval paves the way for the company to offer its testing services to a broader range of healthcare providers and patients within New York State.
The TR8 PGx test is designed to assist healthcare professionals in determining the most effective medications for patients based on their genetic makeup. The test, which requires a prescription, analyzes 120 genetic markers across more than 30 genes to predict individual responses to drugs used in treatments for cardiovascular diseases, oncology, psychiatric conditions, infectious diseases, and pain management. The test is administered using a simple cheek swab.
Dr. James A. Hayward, president and CEO of Applied DNA, expressed confidence in the potential market for PGx testing in New York and the company's plans to actively seek partnerships with employers, healthcare systems, and large-scale enterprises to establish a foothold in the market. Hayward emphasized the significance of the NYSDOH's rigorous standards and the company's commitment to advancing personalized medicine.
Applied DNA's subsidiary, Applied DNA Clinical Labs, LLC (ADCL), which is both NYSDOH CLEP-permitted and CLIA-certified, developed the TR8 test. While the test is now available for clinical purposes, it has not been cleared or approved by the U.S. Food and Drug Administration.
Research has shown that PGx testing can reduce healthcare costs and improve patient outcomes when integrated into large-scale healthcare applications. Applied DNA believes that their service can lead to improved healthcare quality and efficacy.
This announcement is based on a press release statement from Applied DNA Sciences, Inc. and does not constitute an endorsement of the company or its services. The TR8 test's approval by NYSDOH marks a regulatory milestone for Applied DNA and could potentially influence the personalized medicine landscape in New York State.
In other recent news, Applied DNA Sciences has announced significant developments in its operations. Firstly, the company has secured a patent for its Linea RNAP enzyme composition, integral to its Linea IVT platform, from the U.S. Patent and Trademark Office. This development extends the patent's life until 2041 and strengthens the company's position in the mRNA production sector.
Additionally, Applied DNA Sciences disclosed a public offering expected to generate approximately $12 million in gross proceeds. These funds will be used to expand its Therapeutic DNA Production Services and MDx Testing Services.
In the realm of strategic collaborations, the company has partnered with HDT Bio to expedite vaccine production and with Alphazyme LLC to scale up the production of the Linea RNA polymerase.
However, H.C. Wainwright has lowered its price target for Applied DNA Sciences shares to $1.50 from the previous $7.00, despite this, the firm continues to endorse the stock with a Buy rating. The company also confirmed a 1-for-20 reverse stock split of its common stock, aimed at ensuring compliance with the Nasdaq's minimum bid price requirement.
These are recent developments and it remains to be seen how these decisions will impact the company's future operations.
InvestingPro Insights
As Applied DNA Sciences, Inc. (NASDAQ:APDN) secures approval for its TR8 pharmacogenomic testing service in New York State, investors may be evaluating the company's financial health and market position. Here are key insights derived from InvestingPro metrics and tips:
Despite the recent regulatory milestone, InvestingPro data reveals a challenging financial landscape for Applied DNA Sciences. The company's market cap stands at a modest 5.1M USD, and its revenue has seen a significant decline of 68.52% over the last twelve months as of Q2 2024. Additionally, with a gross profit margin of 33.98%, the company maintains some operational efficiency, although this is overshadowed by an operating income margin of -261.64%, indicating substantial losses relative to its revenue.
Investors should note that the company's stock price has experienced a marked decrease, trading near its 52-week low, which is reflected in a staggering 98.11% one-year price total return as of the current date in 2024. This performance aligns with InvestingPro Tips highlighting that the stock has taken a big hit over the past week and has fared poorly over the last month. Furthermore, the company holds more cash than debt, which is a positive sign, but analysts do not anticipate profitability this year, and the stock generally trades with high price volatility.
For those considering an investment in Applied DNA Sciences, it's crucial to weigh these financial metrics against the potential market opportunities presented by the approval of their TR8 test. The company's commitment to personalized medicine could pave the way for future growth, but current financial indicators suggest caution. For a more comprehensive analysis, investors can access additional InvestingPro Tips by visiting https://www.investing.com/pro/APDN. There are 17 additional tips available, offering deeper insights into the company's performance and prospects. To explore these valuable tips and more, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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