The U.S. Food and Drug Administration has given the go-ahead for a trial to use an assay from Hologic and Grifols to test the U.S. blood supply for the Zika virus. The IND study will use the Procleix Zika virus blood screening assay to test donated blood coming from potential endemic areas in the southern U.S.
Hologic ($HOLX) and Grifols ($GRFS) noted that testing could expand to other regions in the country, should the virus continue to spread. The American Red Cross plans to begin blood donor testing for Zika early this summer as part of the study.
"Today's announcement demonstrates our ability to quickly develop molecular diagnostics in response to new and emerging pathogens," Tom West, division president of diagnostic solutions at Hologic, said in a statement.
Procleix systems are part of Grifols' nucleic acid technology products and are used to screen more blood donations worldwide than any other NAT product, the announcement alleges. These include tests for HIV, hepatitis, West Nile virus and more.
The Procleix Panther system has a single integrated platform where all aspects of NAT testing are automated. There is no batch processing and it offers "walk-away" freedom. According to the announcement, the system has regulatory approvals in other countries around the world and is in development in the U.S.
In light of the current outbreak, the FDA is hustling to get Zika tests on the market. Scientists also asked for rapid development of Zika tests back in early February. Of course, those tests then need quick approval from the FDA to get them into the market.
The FDA has been issuing Emergency Use Authorizations for Zika tests in some situations. Such an authorization was issued for the Trioplex Real-time RT-PCR Assay in March. Quest Diagnostics ($DGX) became the first commercial lab to receive Emergency Use Authorization in April.
That doesn't mean the FDA is looking to let people slide without proper authorization. MD Biosciences received a finger wag from the FDA after the company marketed its Zika test without proper approval.
According to the U.S. Centers for Disease Control and Prevention, mosquito-borne transmission of Zika has been found in the Commonwealth of Puerto Rico, the U.S. Virgin Islands and American Samoa, all U.S. territories. However, mosquito-borne cases of the virus have not been seen within U.S. states, though travel-related cases have occurred.
- here is the announcement