In addition to recommendations, guidance, and emergency use authorizations, FDA wants to do more to support development of Zika diagnostic tests.
In recent weeks, FDA has responded to the Zika virus outbreak by publishing recommendations on ways to reduce the risk of transmission, authorized emergency use of the CDC’s Zika detection assay, and put out guidance recommending the deferral of blood donors who have Zika or may have been exposed to the virus. But the agency wants to do more, according to one official.
Heike Sichtig, PhD, a principal investigator and regulatory scientist in medical countermeasures/multiplex within CDRH’s division of microbiology devices, said that FDA wants to include the genome sequence for the Zika virus in its FDA-ARGOS database. Sichtig made the comments this week at the Molecular Med Tri-Conference in San Francisco.
The FDA dAtabase for Regulatory Grade micrObial Sequences (FDA-ARGOS) database is a collaboration between the agency, the National Center for Biotechnology Information (NCBI), the Department of Defense (DoD), and the Institute for Genome Sciences at the University of Maryland. NCBI describes it as a "publicly available, well-curated reference database" that can be used by makers of diagnostic tests. According to NCBI, "Continued success of the database and adoption by the community is contingent on populating and curating the database, which in turn will support development of guidance and standards for clinical use of this technology."
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Noting that a couple strains of the Zika virus have been sequenced and published, Sichtig said,
We also applied for funding to include [Zika] in the database (FDA-ARGOS). We've made the need available to everybody that this is something that we need to include in the FDA-ARGOS database because of test development . . . What we'd love to have is just five samples and we're currently working on acquiring samples. So, if anyone has any outreach for that, let us know. What we'd like to do is include these reference sequences and then qualify already existing because there's already all this great information out there into the database."
Sichtig's comments follow recent agency actions such as new FDA guidance with recommendations for blood collection establishments on deferral periods for blood donations from people who may have been exposed to the Zika virus, as well as recent guidance on donation of human cells, tissues, and cellular and tissue-based products.
FDA last month authorized emergency use of CDC's Zika Immunoglobulin M Antibody Capture Enzyme-Linked Immunosorbent Assay test to Zika virus antibodies detection. This week, HHS announced it sent U.S. blood products to Puerto Rico to shore up the island's blood supply.
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