FDA’s approval of emergency Zika test may ease anguish for pregnant women

With surprising speed that silenced many of its most vocal critics, the U.S. Food and Drug Administration issued an “emergency use authorization” for a much-needed Zika virus test.

The test, developed by Quest Diagnostics, is the first to be authorized for emergency use from a commercial laboratory provider. Up until now, the only Zika tests authorized by the FDA were available from the Centers for Disease Control and Prevention, and were analyzed only in CDC-designated laboratories.

Called RNA (ribonucleic acid) Qualitative Real-Time RT-PCR, the molecular test is designed to detect and measure the Zika virus in human blood. Health officials have repeatedly documented that Zika infection during pregnancy can cause fetal microcephaly and other potentially lethal birth defects. CDC is still studying the full range of other potential health problems that Zika infection during pregnancy may cause.

The wide availability of this new test could reduce the enormous emotional stress reported among pregnant women waiting to determine whether they have the virus, according to physicians and nurses treating them.

Quest is wasting no time getting the test to physicians. The company said it hopes to have the testing material distributed by early next week. This includes Puerto Rico, where the viral infection has been found in more than 400 patients.

The test costs about $500, according to Quest. This includes pickup from the physician’s office, delivery to an airport and shipment to the nearest Quest lab authorized to analyze the blood sample. Uninsured patients may be able to get the test for $120.

ZIKA PAHOThe company touts its expertise in infectious disease, and women’s health diagnostics, and says it already has business relationships with half of the country’s physicians and hospitals so the implementation of the new test should be rapid.

“This capability uniquely positions Quest to complement the response of public health laboratories for Zika outbreaks where access to FDA authorized diagnostic tests can potentially influence the quality of patient management,” said Dr. Rick Pesano, Quest’s vice president for research and development.

Quest has a previous record of being granted emergency use by the FDA. In 2009, during the raging pandemic of H1N1 influenza virus, the company was the first to develop a diagnostic test.

While the CDC has reported that mosquitoes carrying the Zika virus are expected to be limited to only the hotter climate of the southern U.S., the disease experts caution that between 40 million and 50 million tourists, business travelers and students come from Zika-infested areas of South and Central America and the Caribbean into the U.S. each year. More than 400 travel-associated Zika cases have been reported in the U.S. And thus, CDC said, the broad availability of Zika detection protocols is vital.

As Cold Truth reported earlier, the White House is battling Congress to approve $1.9 billion that government health agencies determined is needed to try to stem the fast-spreading disease.


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