Healthcare Business

Why This FDA Update Is Huge for Applied DNA Sciences

Chris Lange

Applied DNA Sciences Inc. (NASDAQ: APDN) shares made an incredible gain on Thursday after the company announced it had received an update from the U.S. Food and Drug Administration (FDA).

Specifically, the FDA has provided Emergency Use Authorization (EUA) for the clinical use of the Applied DNA’s patent-pending Linea COVID-19 RT-PCR test. Clinical Laboratory Improvement Amendments (CLIA) labs can immediately begin ordering and using the Linea COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19.

Note that while the Linea COVID-19 assay kit has been approved by FDA under an EUA for clinical use in CLIA certified labs, the test has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition. This is the case when the secretary of the U.S. Department of Health and Human Services (HHS) declared a public health emergency in regards to the novel coronavirus.

Again, while this is not approved in the traditional sense, this definitely swings open the door to approval. In cases like this, approval should only be a matter of time.

Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA and a 30-year veteran of the RNA-based molecular diagnostics industry, commented:

We believe we have developed an assay with numerous commercial advantages over other EUA approved COVID-19 detections assays. We developed the Linea COVID-19 assay kit for high-throughput operations where rapid high-volume testing is requisite. In addition, we have worked closely with our supply chain partners to evolve safeguards to ensure a steady supply of inputs necessary for the construction of our kit.

Applied DNA stock traded up about 54% to $13.68 on Thursday, in a 52-week range of $2.52 to $27.20. The consensus price target is $8.00.