FDA clears Zika test and plans to revoke emergency authorizations

Diving Brief:

• The FDA granted InBios the first non-emergency marketing authorization for a Zika virus diagnosis.

• The test, ZIKV Detect 2.0 IgM Capture ELISA, is designed to detect anti-Zika immunoglobulin antibodies in blood samples, allowing doctors to confirm suspicious infections.

• ZIKV Detect is one of five Zika-based antibody diagnoses previously authorized to be used under the FDA Emergency Use Authorization. The FDA is currently studying the possibility of revoking the USA from the other four tests.

Insight on diving:

In 2016, CDC received Reports of more than 40,000 cases of symptomatic Zika virus disease across the Americas and its territories, fueling a race for product development to diagnose infections with the pathogen. ZIKV Detect is one of the 19 Zika tests approved under the EUA procedure, allowing the FDA to authorize the use of unapproved products in an emergency.

InBios is now the first company to obtain conventional authorization for a Zika test. This two-step process allowed InBios and the FDA to respond to the urgent need for Zika diagnostics before fully validating the test.

"We have ensured the rapid availability of testing within the framework of the EUA, but we have continued to work with the manufacturers of diagnostic systems to ensure the safety and efficacy of products, and their authorization under the authority of our traditional pre-market authorities, "said Acting FDA Commissioner Ned Sharpless in a report.

InBios has obtained marketing authorization by presenting the results of badytical studies and a clinical trial conducted on 807 samples. The data persuaded the FDA to grant InBios approval as part of its market-launch badessment process, which could lead to the revocation of the US. outfit by Chembio Diagnostic Systems, Siemens Healthcare Diagnostics, DiaSorin and CDC.

The FDA is currently reviewing whether the authorization means that there is now an "adequate, approved and available alternative" to the other four antibody-based tests authorized under the procedure of the "Drug Control Agency". USA. The agency meets with the EUA holders before making a decision on the revocation of the USA. Diagnostics with 14 Zika nucleic acids available in the USA are not affected by ZIKV Detect authorization.

The need for the 19 Zika tests has dropped significantly since the FDA has released many EUAs. In 2016, the CDC received reports of more than 5,000 symptomatic cases of Zika virus disease in US states. Most cases involved people who had traveled outside the United States, but 224 cases were also reported to have been caused by mosquito bites in Florida and Texas.

The risk that infections during pregnancy cause neurological complications and microcephaly made Zika a significant public health problem, but the number of cases in the United States and its territories has dropped since 2016. Last year, the United States and its territories seen 72 and 148 cases, respectively. So far this year, only one case has been reported. The last report of local transmission dates back to 2016.

However, other parts of the world continue to fight the virus. Last year, Brazil reported 19,020 cases of the disease. In the first nine weeks of 2019, the number of cases increased slightly compared to the corresponding period of last year.