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FDA Issues Emergency Use Authorization for Influenza A/H7N9 Rapid Test

Hong Kong reported a new case of influenza A/H7N9 last week and the CDC warned that the virus could make its way to the U.S.

Influenza A/H7N9, a new strain of the avian influenza first identified in China in 2013, kills one in three people infected. The virus moved across China in two successive waves, crossing the border into Hong Kong, Taiwan and Malaysia.

The privately held Arbor Vita Corporation announced this week that the FDA issued an emergency use authorization for its AVC A/H7N9 influenza rapid test for the presumptive detection of the virus in patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors.

“The AVC A/H7N9 Influenza Rapid Test is a potent early surveillance tool,” Dr. Peter Lu, the CEO of Arbor Vita Corporation, said. “This test is suitable for early, point of care screening in strategic locations such as borders checks, airports, US company clinics in China, etc. Early detected infections are then confirmed by molecular tests, such as PCR in large reference laboratories.”

“We are proud and excited to receive FDA’s authorization under an EUA for the first rapid test able to diagnose patients suffering from this deadly respiratory infection.” Lu said. “We applaud the FDA’s efforts to authorize the test. This test may prove to be critical at containing a potential avian influenza pandemic.”

Arbor Vita was approached by the U.S. Navy in spring 2013 to develop a simple and accurate test to detect the virus after Arbor Vita demonstrated success in developing a similar test for influenza A/H5N1. The test was required to be simple enough for non-laboratory personnel to use in the field.

“We have confirmed that Arbor Vita’s test can detect human H7N9 viruses. The dual testing system – Influenza A virus and A/H7N9 virus – clearly has a great advantage.” Dr. Leo Poon, an associate professor at the Center of Influenza Research and School of Public Health at the University of Hong Kong, said.

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