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STONY BROOK, NY - Applied DNA Sciences, Inc. (NASDAQ:APDN), specializing in PCR-based DNA technologies, has announced a strategic shift for its clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL). The company is now focusing its TR8™ PGx pharmacogenomics testing service on specific subpanels for indication-specific use cases, in addition to offering full panel testing. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 4.72 and holds more cash than debt on its balance sheet, though it faces challenges with cash burn rates.
The initiative begins with a subpanel targeting patients with genetic variants of the DPYD gene, which can indicate reduced or absent DPD enzyme activity. This enzyme is crucial for metabolizing fluoropyrimidines, such as capecitabine and fluorouracil, common chemotherapy drugs used in treating various cancers. The move follows a recent FDA safety announcement addressing the risks for patients with certain DPYD genetic variants who may experience severe toxicities from these medications.
ADCL’s TR8 PGx test, approved by the New York State Department of Health, includes 120 genetic targets across more than 33 genes, aiding healthcare providers in tailoring drug therapies. The test, administered via cheek swab, has been available since June 2024.
The decision to introduce subpanels aims to enhance the utility of PGx testing services for healthcare institutions and clinicians, potentially improving patient outcomes by informing prescription choices. Dr. James A. Hayward, CEO of Applied DNA, highlighted the FDA’s safety announcement as a testament to the value of genetic testing in clinical decision-making. The company plans to introduce more subpanels for oncology, cardiology, and psychiatry.
In 2022, approximately 924,000 prescriptions were written for fluorouracil and capecitabine. Data indicates that 1 in 1,000 patients have two copies of a DPYD gene variant, leading to a lack of DPD enzyme, and 3-8% of the population carry one copy, with a higher prevalence in African Americans, placing them at increased risk of adverse effects from these drugs.
Applied DNA Sciences is a biotechnology firm focused on the production and detection of DNA using PCR technology. Its operations span the enzymatic synthesis of DNA for nucleic acid-based therapeutics and the detection of DNA and RNA for molecular diagnostics and genetic testing services. The company’s financial metrics reveal significant headwinds, with revenue declining by 58.46% over the last twelve months to $3.74 million. InvestingPro analysis indicates the stock is currently undervalued, with 16 additional ProTips available to subscribers covering crucial aspects like profitability outlook and market momentum.For investors seeking deeper insights, InvestingPro offers a comprehensive research report on APDN, part of its coverage of over 1,400 US stocks, providing detailed analysis of the company’s financial health, market position, and growth prospects.
This news is based on a press release statement from Applied DNA Sciences, Inc.
In other recent news, Applied DNA Sciences reported a significant increase in revenue for the first quarter of fiscal year 2025, rising to $1.2 million from $891,000 in the previous year. Despite the revenue growth, the company faced an operating loss of $3 million, an improvement from the prior $3.8 million loss. Applied DNA is also seeking approval from the New York State Department of Health for its new bird flu test, a move that could expand its virology testing services. Additionally, the company announced a 1-for-50 reverse stock split to meet Nasdaq’s listing requirements, reducing its outstanding shares from approximately 55.2 million to about 1.1 million.
The company faced challenges at its special stockholder meeting, failing to secure a quorum, which delayed approval for certain warrants linked to a previous stock offering. This necessitates another meeting to seek the required stockholder approval. Analysts from H.C. Wainwright have been following these developments closely. Applied DNA’s strategic restructuring includes a 20% workforce reduction, aiming to optimize costs and focus on its LinearRx platform, which is seen as a growth driver. These recent developments reflect the company’s ongoing efforts to navigate financial challenges while expanding its market presence.
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