Applied DNA Sciences, Inc. (NASDAQ: APDN) announced plans to expand the approved use of its Linea™ Mpox Virus 1.0 test to include detection of mpox Clade I, following the recent declaration of a public health emergency by the World Health Organization. Internal data suggests the test can detect the genetic sequence of mpox Clade I, prompting submission of validation studies to the New York State Department of Health (NYSDOH).
The Linea™ Mpox Virus 1.0 test, approved in September 2022 for the detection of clade II of mpox, could offer clinical testing for clade I and II if approved. Applied DNA intends to complete the filing with the NYSDOH expeditiously, subject to the availability of reagents and materials. The timeline for approval remains uncertain.
Applied DNA Clinical Labs, LLC, certified for high complexity testing, developed the test. It is essential to note that the test has not been approved by the United States Food and Drug Administration and is intended for clinical use only.
The forward-looking statements contained in the press release highlight associated risks, including uncertainties related to validation and approval, and are based on assumptions that may not materialize.
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