Lawmakers Seek Answers from HHS on Availability of Zika Tests
Two House members are calling on HHS Secretary Sylvia Burwell to provide more details of how the department is responding to the Zika outbreak, saying the current status of diagnostic testing for the virus is alarming.
Reps. Tim Murphy (R-Pa.) and Fred Upton (R-Mich.) wrote the letter last week, following a March 2 hearing of the Energy and Commerce Committee’s Oversight and Investigations Subcommittee.
They ask Burwell to explain how the department is working to ensure public-private partnerships and incentives for private companies to produce diagnostics, vaccines and therapeutics against Zika. Currently, no diagnostic tests are commercially available in the U.S. for Zika. Some tests are in use, but they have limitations (IDDM, March 4).
The March 29 letter also seeks information on the current status of research undertaken or funded by HHS, and how the department is coordinating with the Defense Department and Agriculture Department regarding research.
In addition, the House members ask how states can use grant money from the CDC for vector control activities.
The letter requests answers by April 12.
Federal authorities have made some strides to combat Zika. The CDC’s MAC-ELISA test was authorized for emergency use by the FDA Feb. 26 — the same day Burwell determined that Zika poses a significant potential for a public health emergency.
The FDA subsequently authorized the emergency use of the CDC’s Trioplex Real-time RT-PCR Assay March 17. The Trioplex rRT-PCR is authorized to detect and differentiate RNA from Zika virus, dengue virus and chikungunya virus in human sera or cerebrospinal fluid, and to detect Zika virus RNA in urine and amniotic fluid.
On March 30, the FDA authorized an investigational test to screen blood donations for Zika. Availability of the test, developed by Roche Diagnostics, will allow blood establishments in Puerto Rico to resume collecting whole blood and blood component donations.
The cobas Zika test, for use with the cobas 6800/8800 Systems, is for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors.
“The FDA is making this test available while it is still under investigation because there is no equivalent Zika blood donation screening test already authorized for use,” FDA spokeswoman Tara Goodin tells IDDM.
Read the House letter here: www.fdanews.com/03-30-16-ZikaLetter.pdf. The FDA’s authorization letter and notice are here: www.fdanews.com/03-28-16-FDA-Zika.pdf and www.fdanews.com/03-29-16-FDA-ZikaNotice.pdf, respectively. — Jonathon Shacat