PPHM, TKMR, SRPT, BCRX, CMRX, NLNK, LAKE, APT, SMED
FDA issues Emergency Use Authorization for Ebola diagnostic tests
In a letter to BioFire Defense the FDA said: "This letter is in response to your request that the Food and Drug Administration issue an Emergency Use Authorization, EUA, for emergency use of the FilmArray NGDS BT-E Assay for the presumptive detection of Ebola Zaire virus on the FilmArray Instrument in individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus in conjunction with epidemiological risk factors, by laboratories designated by the United States Department of Defense, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act -21 U.S.C. § 360bbb-3. Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act are met, I am authorizing the emergency use of the FilmArray NGDS BT-E Assay in individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus in conjunction with epidemiological risk factors described in the Scope of Authorization section of this letter for the presumptive detection of Ebola Zaire virus by laboratories designated by DoD, subject to the terms of this authorization." Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE), Alpha Pro Tech (APT) and Sharps Compliance (SMED). Reference Link :theflyonthewall.com
