FDA Intervenes on Development of New Zika Test

The health care sector may have developed a rapid detection diagnostic test for the Zika virus, but the U.S. Food and Drug Administration (FDA) may wind up intervening prior to it making a significant impact.

The test was developed jointly by pathologists and researchers at Texas Children’s Hospital in Houston and Houston Methodist Hospital. The two providers announced it in late February.

The Zika virus has become a low-level pandemic in recent months. The virus initially spreads through mosquitoes, but it can also be sexually transmitted from men to women. Although the virus itself causes relatively mild symptoms in adults, children of mothers infected can be born with serious birth defects, including microcephaly. Brazil has been struggling with an outbreak of Zika-related microcephaly since the middle of last year. According to data from the U.S. Centers for Disease Control and Prevention, there were 273 confirmed domestic cases of Zika, all related to overseas travel. Of those, 19 are in pregnant women. Another 286 cases have been reported in U.S. territories, with most of them acquired locally.

“With travel-associated cases of the Zika virus becoming more prevalent in the United States, coupled with the looming increase in mosquito exposure during spring and summer months, we must be prepared for a surge of Zika testing demand,” said James Versalovic, M.D., chief pathologist at Texas Children’s Hospital. “We must provide answers for anxious moms-to-be and families who may experience signs and symptoms or may simply have travel history to endemic areas.”

The test, which focuses on RNA analysis, can be deployed using blood, amniotic fluid, urine or spinal fluid. Turnaround is a few hours, officials said.

Days after the hospitals made the joint announcement, the FDA sent an “it has come to our attention letter” to Versalovic and James Musser, M.D., a pathology professor connected with Houston Methodist.

“We believe that due to the current public health emergency it is appropriate for the Food and Drug Administration to review information related to the development of the test,” the letter said. “Based on our review of your promotional materials, we believe you are offering a high risk test that has not been the subject of premarket clearance, approval, or emergency use authorization review by the FDA. The FDA would like to better understand the test’s design, validation and performance characteristics, and in addition, CDC and CMS have asked us to review the science behind your test.”

There is currently only one test for Zika approved by the FDA for commercial use on an emergency basis. That test, developed by the CDC, focuses on antibodies and is not 100 percent accurate.

The FDA’s questioning about the test is likely being spurred over a clash with the sector over its proposed regulation of laboratory developed tests. The agency claims that many assays, due to their complexity and touted diagnostic powers, could pose dangers to patients if they are not properly regulated. Last year, the FDA released a remarkable report listing 20 current and former lab tests it claimed were potentially dangerous.

Laboratory leaders have fiercely resisted the proposal, saying that relatively minor changes to CLIA regulations would suffice. The FDA has yet to issue final guidelines. A spokesperson for Texas Children’s Hospital and Houston Methodist Hospital did not respond to a query seeking comment.

Takeaway: The Food and Drug Administration may intervene in the distribution of any laboratory developed tests related to the Zika virus.