Seattle's InBios: First to receive FDA authorization for Zika test

The images of children born with microcephaly -- or small heads -- stunned the world when the Zika outbreak exploded in 2015.

Late last month, Seattle's InBios International received FDA market authorization for its presumptive diagnostic test for Zika virus infection, which could help prevent Zika-related birth defects worldwide.
"It's extremely sad to see the impact this disease has on people and their children," InBios Quality Control Manager Shivani Dharmaraja told KIRO 7 on Wednesday.

The South Lake Union company develops and manufactures immuno-diagnostics for infectious diseases.

When Zika -- a flavivirus --- started to spread, InBios already had diagnostic kits available for two similar flaviruses, West Nile and Dengue, so it had a head start creating a Zika-specific test kit, according to Wendy Bagnato, senior marketing and sales manager.

“When we started hearing about the surge in cases, and we started hearing about the connection to birth defects and microcephaly, we knew we needed to get together a kit as soon as possible, develop a kit that was very accurate, specifically for Zika,” Bagnato said.

Dharmaraja said the worldwide availability of ZIKV Detect 2.0 IgM Capture ELISA is important for travelers returning from Zika-endemic areas, especially those experiencing flu-like symptoms.

“If the doctor suspects that you may have contracted Zika at some point, they could suggest that this test be run at a laboratory,” Dharmaraja explained.

The results of that test could impact women, especially.

“If you are thinking about getting pregnant, you may be advised by your doctor to wait a certain amount of time,” if a test is positive for Zika, Bagnato said.

The test takes a private or public health lab four hours to process, so results aren't immediate. However, Bagnato said InBios is also working to develop a kit with rapid results, such as a urine-based pregnancy test.

For more info: https://inbios.com/ 

For travelers:  https://wwwnc.cdc.gov/travel/page/zika-travel-information 

For CDC info on zika: https://www.cdc.gov/zika/index.html

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