The Procleix Zika virus screening assay was approved for testing donated blood in areas of the southern U.S. deemed vulnerable to the virus, which has already been implicated in severe birth defects in Latin America. Although no indigenous cases have been reported in the continental U.S., mosquitoes have infected people as close as Puerto Rico.
The Procleix Zika test is one of a suite of nucleic acid technology products developed under the Hologic-Grifols partnership, used in screening blood for HIV, hepatitis, West Nile virus and other pathogens.
The FDA's decision follows another emergency authorization late Friday for Hologic's Aptima Zika virus assay to test individuals who are showing symptoms of infection or who have traveled in Zika-infested areas. The emergency authorizations allow use for as long as the agency considers the threat an emergency, but they aren't the same as a market approval.
"While positive, the financial impact of the approval should be minimal," Jefferies analyst Raj Denhoy wrote after the Friday authorization. "Hologic's test is the fourth now available, and the use case for individual testing is still very limited."
He added, however, that "authorization for Zika testing in blood screening is expected any day, and that test has the potential to be more meaningful," presumably referring to the Procleix.
Hologic stock rose 1% to 34.14 on the stock market today. Hologic stock holds a solid EPS Rating of 86, but its Relative Price Strength Rating has been floundering since its Q3 guidance disappointed investors in late April. Grifols stock has been forming a saucer-with-handle base since early November, with a 17.50 buy point, but its earnings have declined the last two quarters. Grifols stock closed up 0.7% at 15.58.
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