CDC Presses Industry for Antibody-Based Zika Diagnostic

The Centers for Disease Control and Prevention is urging industry to develop antibody-based Zika diagnostic tests.

In exchange, the agency said it prepared to offer non-exclusive license agreements to develop the tests, as well as materials, information and technology transfer.

CDC Director Tom Frieden told reporters at the National Press Club that no company has taken the agency up on its offer to develop a much-needed antibody-based test that would help to distinguish the infection from others.

He noted that CDC scientists have optimized testing for a rapid, highly sensitive test that can detect the virus in urine or blood in acutely infected individuals, and those tests have been disseminated to 100 labs around the U.S. and globally.

But more effective antibody-based diagnostics are desperately needed to determine if someone has been infected in the past. Frieden acknowledges that a non-exclusive license could pose a potential marketing barrier to manufacturers seeking to exclusively develop tests using CDC’s groundwork.

He said the agency originally reached out to a diagnostic manufacturer to contract out development of Zika diagnostics, but the company’s year production timeline would not address the immediate need.

The U.S. Senate and House separately passed spending bills in late May to fight the Zika virus with measures that include HHS funding for vaccines, therapies and diagnostic tests.

The Senate passed an amendment to a transportation appropriations bill that provides $150 million for an HHS emergency fund to spur the development of Zika countermeasures. A $622 million measure passed the House that would allocate $103 million for the development of preventative measures.

The FDA also has issued four emergency use authorizations, mostly for polymerase chain reaction (PCR) tests for the virus (IDDM, May 2). — Joya Patel