Applied DNA Sciences Inc. (NASDAQ: APDN), a leader in PCR-based DNA technologies, has once again made headlines with a significant development in its clinical testing capabilities. On August 23, 2024, the company announced that its wholly-owned subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH). This submission is aimed at expanding the use of its Linea™ Mpox Virus 1.0 Assay to include both mpox clade I and clade II.
A Deeper Look at the Linea™ Mpox Virus 1.0 Assay
The Linea™ Mpox Virus 1.0 Assay, developed by ADCL, was initially approved by NYSDOH in September 2022 for the detection of mpox clade II. The recent validation studies have shown that the assay’s primers and probe exhibit 100% homology to mpox clade I and clade Ib. This expansion is particularly timely given that clade Ib was recently the subject of the World Health Organization’s (WHO) public health emergency declaration.
If the NYSDOH approves this expansion, Applied DNA Sciences will be able to offer clinical testing services for both mpox clades in its CLEP/CLIA-certified molecular diagnostics laboratory located in Stony Brook, New York. This would allow the company to serve not only New York but also other states that recognize New York’s CLEP/CLIA certification.
The Role of ADCL in Clinical Testing
ADCL, the clinical laboratory arm of Applied DNA Sciences, is certified to perform high-complexity testing under both the Clinical Laboratory Improvement Amendments (CLIA) and the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP). The Linea™ Mpox Virus 1.0 Assay, although not yet cleared or approved by the U.S. Food and Drug Administration (FDA), is intended for clinical purposes and has been specifically developed and validated by ADCL.
About Applied DNA Sciences
Applied DNA Sciences operates at the forefront of DNA technology, utilizing polymerase chain reaction (PCR) to both produce and detect DNA across various applications. The company is divided into three primary business markets:
- Synthetic DNA Production: Applied DNA specializes in the enzymatic manufacture of synthetic DNA, which is crucial for producing nucleic acid-based therapeutics. Additionally, the company has developed a proprietary RNA polymerase (RNAP) for use in mRNA therapeutics, a rapidly growing field in biotechnology.
- Molecular Diagnostics and Genetic Testing: Applied DNA provides DNA and RNA detection services through molecular diagnostics and genetic testing, supporting both clinical and research needs.
- Supply Chain Security: Beyond healthcare, the company’s DNA technology is also employed for industrial supply chain security services, where the manufacture and detection of DNA are used to ensure the authenticity and traceability of products.
Market Impact and Future Prospects
As of August 23, 2024, Applied DNA Sciences saw its stock price surge to $3.00, reflecting a significant increase of 63.91%. This spike can be attributed to the positive market reception of the company’s potential expansion in clinical testing services and its innovative contributions to DNA technology.
The approval of the Linea™ Mpox Virus 1.0 Assay for clade I could open new avenues for Applied DNA Sciences, potentially expanding its market reach and solidifying its position as a leader in molecular diagnostics. With its strong focus on innovation and expanding capabilities, Applied DNA Sciences is well-positioned to capitalize on the growing demand for advanced DNA-based technologies and services.
Conclusion
Applied DNA Sciences continues to push the boundaries of DNA technology, with its latest efforts aimed at expanding the clinical applications of its mpox virus assay. As the company awaits regulatory approval from the NYSDOH, it remains committed to delivering cutting-edge solutions that address both current and emerging challenges in biotechnology and healthcare. Investors and stakeholders alike should keep a close eye on the company’s developments, as they have the potential to significantly impact the future of molecular diagnostics and synthetic DNA production.
