The FDA has issued emergency approval for Roche’s Zika diagnostics test in a bid to prevent the disease from spreading further.
The authorization for the Swiss drug-maker’s test skirted the usual approval channels as part of the regulator’s battle against the virus.
The Zika virus was found in various areas, including Brazil, last year. It has since spread to many other countries. It has been linked with microcephaly, which is a birth defect whereby babies are born with abnormally small heads and face potential problems with development.
Blood Testing Recommended by FDA
As reported on the official website of the US Food and Drug Administration website, the FDA has previously recommended that all donated blood samples and blood components are tested for the Zika virus in America and its territories.
The FDA’s director of the Center for Biologics Evaluation and Research, Peter Marks, said that the testing of the total blood supply should ensure safety for those needing transfusions.
There were 2,517 Zika cases reported in the US in one week towards the end of August, and it is believed that 29 of these were acquired in Florida as a result of mosquito bites. The rest were thought to have affected travellers. Another 9,000 incidences have been noted in American territories, including in Puerto Rico.
Screening of Patients with Zika Symptoms
Just as organisations such as http://www.fdathirdpartyreview.com/ can help clients fast-track Medical Device Submissions and answer questions such as how long does it take to get an FDA 510k approved, the FDA has rushed through the approvals process to allow Roche’s test to be used in the screening of patients showing signs of the Zika virus. These symptoms, which meet CDC criteria, include a rash, fever, red eyes and joint pain.
A Roche spokesman explained that samples from patients will be analysed at specially certified laboratories.
The FDA has the power to grant Emergency Use Authorization if there is a public health emergency. This allows previously unapproved medical products to be quickly deployed.
In March, Roche was granted separate FDA investigational approval for a testing system that could test blood at American centres, including those in Puerto Rico. Around one per cent of blood that has been donated has tested positive for Zika so far in Puerto Rico.