The FDA has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.'s Gene-Radar Zika virus test. The Cambridge, Mass.-based company's diagnostic is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention (CDC) and/or epidemiological criteria by U.S. laboratories.
Gene-Radar's EUA comes prior to the summer months where conditions are favorable for mosquitoes that can transmit the Zika virus. There are an estimated 4,800 people infected with Zika in the U.S., with an additional roughly 35,000 in the U.S. territories – primarily in Puerto Rico, according to CDC statistics.
Frequently, there can be lag time or a long wait for results of Zika tests on the market. Nanobiosym has developed the Gene-Radar to obtain quick results for patients and to lower the cost to test Zika, said Anita Goel, the company's founder and CEO. Goel is a physicist and physician, widely recognized for her pioneering research in nanobiophysics.
Goel's device uses nanotechnology to build a miniature testing lab on a thumbnail-size chip. Human serum is placed on the chip, which is loaded into a testing device about the size of a laptop or mobile tablet. The company is developing expanded clinical sample input options to include other body fluids such as whole blood and urine.
"We live in an age where some of these infections spread very fast," Goel told Medical Device Daily. "We're using in many cases an old outdated infrastructure, which is based on a centralized diagnostic system. One of my arguments is that in an age of information and communication where infections can spread almost at the speed of light, we need to have the world's best technology to protect us against diseases."
OTHER MOVEMENTS IN ZIKA
Nanobiosym's EUA comes on the heels of Abbott Laboratories Inc. receiving an FDA nod for a whole blood Zika detection test. (See Medical Device Daily, Feb. 3, 2017.) The Abbott Park Ill.-based company's Zika molecular test provides results within five to seven hours.
Abbott is continuing its Zika research and development on at least a couple of fronts: to develop a point-of-care diagnostic and, separately, to create a serology-based test that does not produce false Zika positives based on exposure to other tropical diseases.
Last year, Bethlehem, Pa.-based Orasure Technologies Inc. was selected to receive up to $16.6 million from the U.S. Department of Health and Human Services to develop a rapid molecular diagnostic that tests for the disease's antibodies. (See Medical Device Daily, Aug. 25, 2016.) The funding comes from the agency's Biomedical Advanced Research and Development Authority. The six-year award is worth at least $7 million, and includes optional funding of $9.6 million to fund the evaluation of product enhancements and other clinical and regulatory activities.
The list for Zika tests is constantly growing. The CDC has developed two diagnostics for the disease, the Zika Mac-Elisa and Trioplex Rrt-Pcr. Other diagnostics for the disease include the Realstar Zika Virus RT-Pcr, developed by Hamburg, Germany's Altona Diagnostics; the Zika Virus RNA Qualitative Real-Time Rt-Pcr, developed by San Juan Capistrano, Calif.-Focus Diagnostics Inc., a unit of Quest Diagnostics; the Xmap Multiflex Zika RNA Assay, developed by Austin, Texas-based Luminex Corp.; the Zikv Detect Igm Capture Elisa, developed by Inbios International; and Marlborough, Mass.-based Hologic Inc.'s Aptima Zika virus assay.
In addition, Hologic has received FDA's permission to use a Zika virus blood screening assay in conjunction with its Procleix Panther system to screen donated blood collected in endemic areas in the southern U.S., in partnership with Spain-based Grifols SA.
MOVING BEYOND ZIKA
Ultimately, Goel sees the Gene-Radar test as a tool much like the fictional Star Trek Tricorder – a hand-held device used for sensor scanning, data analysis and recording data. She was quick to note that the company was far away from that goal, but it was getting closer each day.
Nanobiosym Diagnostics was founded in 2006, but began as the Nanobiosym Research Institute in 2004, which was focused solely on research. Goel said the commercial company has taken on investors but declined to discuss funding.
Goel said she envisions the device eventually obtaining approval to detect diseases such as Ebola, HIV and global pandemics. She noted the device could be useful in undeveloped countries.
"By decentralizing the infrastructure needed to deliver health care, not only are you giving more people access, but you're creating the ability for a nation to respond better in the face of a pandemic or national threat with these kinds of diseases," she said. "Just like cell phones transformed the telecommunications industry, we're trying to do the same with the health care industry [through our diagnostic tests]."