Applied DNA Seeks Approval For PCR-Based Monkeypox Virus Test

  • 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
Market News and Data brought to you by Benzinga APIs
Posted In: NewsPenny StocksHealth CareTop StoriesMoversTrading IdeasGeneralBriefsMonkeypoxwhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!