The FDA is coming down on MD Biosciences for marketing its Zika test without proper approval. The move comes less than two weeks after the company rolled out its RNA diagnostic for the virus.
MD Biosciences' Zika Virus RNA by RT-PCR Assay is meant to quickly pinpoint Zika and distinguish it from other, similar viruses including dengue, West Nile and Chikungunya. But "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 by the FDA," regulators said in a letter to the company.
Now the agency is asking MD Biosciences to turn over more information about its Zika RNA test. Regulators are also giving the Minnesota-based company 7 days to schedule a meeting with the FDA to discuss the issue.
"In light of the current public health emergency, it is particularly important for the FDA to review information related to your Zika Virus RNA by RT-PCR Assay's design, validation, and performance characteristics," the agency said in its letter.
Meanwhile, med tech companies and government officials are heeding health experts' calls for rapid tests for the virus. Last month, the Obama administration asked Congress for $1.8 billion in emergency funding to combat the virus. About half of that funding would go to the Centers for Disease Control and Prevention (CDC), which recently got the FDA's first emergency clearance for its Zika test.
Zika holds "significant potential for a public health emergency," Secretary of Health and Human Services (HHS) Sylvia Burwell said last month. The rising number of cases prompted the FDA to issue its clearance for the Zika test, FDA Commissioner Robert Califf said earlier this month in a note to the CDC.
Last week, Chembio Diagnostics ($CEMI) said that it would work Brazilian biotech organization Bio-Manguinhos/Fiocruz to make POC Zika tests. The Brazilian government recently released new numbers showing more suspected and confirmed cases of microcephaly, a birth defect linked to the virus, in the country. Faster tests could help scientists better understand the association between microcephaly and Zika and stop the virus before it spreads.
"Preliminary testing results are highly encouraging and our ongoing collaborations with Bio-Manguinhos/Fiocruz and the global scientific community are extremely helpful as we move toward a rapid and affordable solution," Chembio CSO Javan Esfandiari said.
- read the letter (PDF)