FDA Approves Use of Zika Virus Assay
The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.
FDA approved the Procleix Zika Virus assay from Hologic and Grifols, the companies announced on June 20, 2016. The assay will be used to screen donated blood supply in potential endemic areas of the southern United States for the presence of the virus. More screening locations will be added should the virus spread across the rest of the US.
The American Red Cross agreed to participate in an investigational study run by Procleix using the screening test for donations. The Red Cross will begin testing for the virus in early summer in areas “most likely to have local mosquito transmission of the virus," said Susan Stramer, PhD, vice-president of scientific affairs at the American Red Cross.
FDA also granted emergency use authorization for the Aptima Zika Virus assay on June 17, 2016, which is a test for the accurate diagnosis of the Zika virus in individuals displaying signs of Zika infection or who have traveled to areas of active transmission.
Source: Hologic, Inc.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
