Applied DNA Seeks Approval For PCR-Based Monkeypox Virus Test

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  • Applied DNA Sciences Inc APDN has submitted to the New York State Department of Health (NYSDOH) a validation package for its monkeypox virus test in support of a request for full approval as a form of NYSDOH Laboratory Developed Test (LDT). 
  • The PCR-based diagnostic is designed to identify the genetic signature of the Clade II variant of the monkeypox virus currently prevalent in the U.S. 
  • Related Content: Applied DNA Sciences Shares Triples After Monkeypox Diagnostic Test Update.
  • Named the Linea Monkeypox Virus 1.0 Assay, the test would be the company's second successful LDT in less than one year if approved by the NYSDOH. 
  • Currently, the FDA has cleared one test to detect monkeypox, offered through the U.S. Centers for Disease Control and Prevention as an LDT. 
  • Applied DNA Sciences' Linea 2.0 COVID-19 Assay received conditional approval as an LDT from NYSDOH in January 2022.
  • Earlier this week, Chembio Diagnostics Inc CEMI said it is evaluating the potential to develop a monkeypox rapid point-of-care (POC) test. 
  • Price Action: APDN shares are up 11.90% at $4.03 on the last check Thursday.
  • Photo Jernej Furman from Flickr
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