FDA Approves Roche Molecular Cobas Test As Zika Virus Blood Donor Screen
US FDA approved Roche Molecular Diagnostics' cobas Zika virus test to screen plasma specimens from blood and organ donors.
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Blood Brothers No More: Hologic Unloads Blood-Screening Business To Partner Grifols
Hologic's partner in the blood-screening business, Grifols SA, will buy-out Hologic's share for $1.85bn. Grifols already owns all the customer-facing parts of the business; it will now take on research, development and manufacture of assays and instruments based on nucleic acid testing for transfusion and transplantation screening.
Hologic/Grifols, Roche Molecular Zika Tests Tapped For Blood-Screening Ramp-Up
A blood-screening test made by Hologic in collaboration with Grifols, and another made by Roche Molecular Diagnostics, are being used in a gradual ramp-up of Zika virus screening at blood donation centers across the US under a new FDA program.
FDA Sunsets VCRP, Will Launch New Portal For Mandatory Cosmetics Registration Under MoCRA
FDA is closing down its 50-year-old Voluntary Cosmetic Registration Program as it prepares a new portal for facility registration and product/ingredient listing under the Modernization of Cosmetic Regulations Act. The Independent Beauty Association says the news marked an important step, but dismayed many stakeholders who hoped VCRP data would transfer to the new system or otherwise be preserved.