Public health scares are characterized by hasty efforts to bring drugs, devices and diagnostics to the newly enlarged market for whichever disease or condition is in the sun. Some efforts are well-intentioned, others are not.
Regardless, the FDA must ensure their safety and efficacy. The agency just informed two providers of unapproved diagnostics for the Zika virus that it needs to review their tests' design, validation and performance characteristics.
"Based on our review of your website and other 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 Food and Drug Administration (FDA)," the agency told Lone Tree, CO's First Diagnostic and Houston doctors James Versalovic and James Musser in a letter.
The letter does not contain any specific warnings of impending enforcement action. It instructs the relevant official to contact the agency within 7 days to schedule a meeting and send the agency the requested information about the tests.
First Diagnostic claims that its "Zika Virus IgG & IgM Lateral Flow Test will provide a rapid, visual and qualitative result in minutes in whole blood, serum or plasma samples."
In a bid to escape the FDA's tentacles, the website says its in vitro diagnostic is for "presumptive screening purposes and for research use only."
Meanwhile, the Texas Children's Hospital and Houston Methodist Hospital claimed in February to have developed the Zika direct test in "a matter of weeks." It apparently works by detecting the virus' RNA. The hospitals said only registered patients can receive the test, which will be offered to those with a positive travel history and symptoms of the mosquito-borne disease.
The FDA issued a similar letter last week to MD Biosciences of St. Paul, MN.
Symptoms of the Zika virus include onset of fever with maculopapular rash, arthralgia, or conjunctivitis, according to the federal Centers for Disease Control and Prevention. It's also suspected of causing congenital microcephaly among the babies of infected pregnant women. The CDC writes that "during the first week of illness, Zika virus disease can often be diagnosed by performing reverse transcriptase-polymerase chain reaction (RT-PCR) on serum."
- read the letter to First Diagnostic | to Drs. James Versalovic and James Musser (PDFs)