Arbor Vita Corporation (AVC), a privately held company, announced this week that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for their A/H7N9 Influenza Rapid Test for the presumptive detection of the influenza A/H7N9 virus (detected in China in 2013) in patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors.
The new strain of the avian influenza virus first appeared in China in 2013. This particular ‘bird flu’, influenza A/H7N9 virus, kills one in three people infected. In two successive and increasing waves, this virus has moved across China and crossed the Chinese border into Hong Kong, Taiwan and Malaysia. As recently as last week, another case of influenza A/H7N9 virus was reported in Hong Kong.
The U.S. Navy first approached Arbor Vita in the spring of 2013 to develop a simple, accurate test to detect the influenza A/H7N9 virus. Arbor Vita had demonstrated success in developing similar testing for the influenza A/H5N1 virus.
Collaborators at the US Navy, Swiss Armed Forces (Spiez Laboratory) and the University of Hong Kong evaluated AVC A/H7N9 Influenza Rapid Test. “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.” says Dr. Leo Poon, associate professor at Centre of Influenza Research and School of Public Health, University of Hong Kong.
“We are delighted to participate to make this surveillance tool available for pre-pandemic setting to help prevent a lethal pandemic,” says Colonel Sergei Bankoul, MD, Senior Consultant to the Swiss Surgeon General.
Access to the influenza A/H7N9 virus proved to be difficult but possible with help from Dr. Leo Poon. Cases of influenza A/H7N9 virus around the Lunar New Year mushroomed as people travelled to visit each other bringing live chickens as presents from affected areas and spreading the virus inside and outside of China.
“The AVC A/H7N9 Influenza Rapid Test is a potent early surveillance tool. 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,” says Dr. Peter Lu, Chief Executive Officer of Arbor Vita Corporation.
“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. We applaud the FDA’s efforts to authorize the test. This test may prove to be critical at containing a potential avian influenza pandemic” concludes Dr. Peter Lu.
The test has additionally been authorized by the DoD network laboratories for use in the US and outside the US, other US government laboratories outside the US, or foreign laboratories.
Source: Arbor Vita Corporation press release, adapted.
