House Passes Bill to Develop Zika Virus Diagnostics, Vaccines

The House passed a bill May 18 that includes $103 million for developing rapid diagnostic tests and vaccines to fight the Zika virus.

The Zika Response Appropriations Act (H.R. 56242) includes $622.1 million in total funding, which includes $230 million for the NIH to support preclinical and clinical development of vaccines. The Centers for Disease and Control would get $170 million to detect the virus globally to protect public health. The remainder would be funded by discretionary funding.

Read the legislation here: www.fdanews.com/05-18-16-ZikaSupplementalAppropriationsBill.pdf.

In related news, the FDA granted Altona Diagnostics an emergency use authorization for its RealStar Kit to detect the Zika virus.

The in-vitro diagnostic test detects Zika Virus RNA in serum or urine samples, and it rules out Dengue and Chikungunya viruses.

The FDA has not cleared or approved tests to confirm Zika virus infection but it has authorized EUA’s for detection. Altona’s test is 1 of 4 to be given an EUA by the FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments. Read the EUA here: www.fdanews.com/05-16-16-AltonaZikaEUA.pdf. — Joya Patel