FDA grants Emergency Use Authorization for Nanobiosym Gene-RADAR Zika diagnostic Test.

Courtesy: Nanobiosym

The US Food and Drug Administration has granted Emergency Use Authorization (EUA) to Nanobiosym's Gene-Radar Zika virus test. Emergency Use Authorization is only granted by FDA for Serious or life-threatening disease or condition to humans.

The WHO reports that Zika virus infection is prevalent and active in more than 60 countries including 40,000 people in the U.S. and its territories, that also includes at least 4,750 pregnant women. The greatest threat of Zika infection during pregnancy is the neurological deficit and damage to the unborn child in the form of microcephaly, decreased brain tissue and brain damage.

About one in 10 pregnant women with confirmed Zika infection had a fetus or baby with birth defects during 2016, said CDC during a press conference.

The Gene-RADAR®Zika Virus Test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the qualitative detection of RNA from Zika virus in human serum and other authorized specimen types.

Gene-Radar technology by Nanobiosym Inc was the winner of the Nokia Sensing XCHALLENGE in 2013. Gene radar is a mobile diagnostic device that allows you to diagnose any disease with a genetic fingerprint in real-time with gold standard accuracy at a price a hundred times cheaper than anything else on the market today.

Zika testing is currently done by either a serological test or nucleic acid based tests, looking for DNA/RNA sequences. Serological testing yield high false-positive rates because of cross-reactivity with Zika-like viruses such as Dengue or Chikungunya. Gene-RADAR Zika test look precisely at the RNA sequence of the virus hence eliminating cross reactivity.

Essentially it is a point of care platform with nanochip test cassettes that can potentially run using a drop of sample, such as serum, blood, or saliva. The machine is the size of our palm, just like an iPad and weighs 3.5 pounds. The consumer can get the results back in an hour, instead of waiting for 1-2 days for other tests.  

The Gene-RADAR® Zika Virus Test is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals in accordance to the CDC’s algorithm for Zika testing.

This test has not been FDA cleared, and is only authorized for use till such time that emergency circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, unless the authorization is terminated or revoked sooner.

"This FDA EUA represents a major milestone towards realizing our deeper vision: to decentralize, personalize, and mobilize the next generation of healthcare, much like cell phones transformed the telecommunications industry," said Dr. Anita Goel, M.D., Ph.D., Chairman and CEO of Nanobiosym and a Harvard-MIT trained physicist and physician. "The FDA's prompt feedback has accelerated our journey from winning the first XPRIZE for healthcare to bringing this new technology to patients and providers battling Zika on the front lines."

Clinical trials are already underway in Rwanda for detecting HIV viral load at point of care. Other application of Gene Radar technology is in fields of personalized medicine and cancer therapeutics.

The full text of FDA authorization could be accessed here.

             Nanobiosym’s XPRIZE winning-video about the Gene-Radar technology.