The Philippine Food and Drug Administration (FDA) said today that it has approved the use of a COVID-19 testing kit that was developed by a research center at the University of the Philippines (UP) in Manila, just as the number of coronavirus cases in the country hit 33 this afternoon.
The FDA said it has exempted the much-needed kits from registering as a medical device, and said the devices — which were funded by the Department of Science and Technology and developed at UP’s National Institute of Health — will be used “for field testing coupled with gene sequencing at the Philippine Genome Center.”
FDA Director-General Eric Domingo added in the agency’s statement that “the increasing number of reported COVID 19 cases will require immediate diagnosis and monitoring.”
“This will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in early screening of positive cases. Furthermore, this will provide greater access to a less costly diagnostic procedure,” the FDA chief added.
Lead scientist Dr. Raul Destura, director of U.P.’s Institute of Molecular Biology and Biotechnology, told ABS-CBN News that Filipino scientists developed the test kits several weeks ago after the World Health Organization released the genome sequence of the virus, but “the limiting factor was bringing in the raw materials in the country. We’re doing the protocol for [a] strict manufacturing process.”
Meanwhile, Department of Health (DOH) Secretary Francisco Duque III admitted to reporters over the weekend that a lack of testing kits may have led to the unintentional “under-reporting” of virus cases in the country. For weeks the number of confirmed cases stood at just three, all of whom were Chinese nationals from Wuhan.
Officials with the Research Institute of Tropical Medicine (RITM) in Muntinlupa, where most virus cases are being tested and treated, said in a Senate inquiry yesterday that it only has around 2,000 coronavirus test kits, and is awaiting 4,500 more kits from the World Health Organization, GMA News reports.
“I don’t want to panic but you’re making me panic,” Senator Nancy Binay said in response to the figure. “We only have 2,000 testing kits out of our 100 million population. Aren’t you scared?”
The beleaguered Philippine Amusement and Gaming Corporation, meanwhile, vowed yesterday to donate PHP2 billion (about US$39.6 million) to the DOH to help the agency deal with COVID-19. The announcement came shortly after President Rodrigo Duterte said he had no plans of shutting down online gambling operators despite widespread criticism of the industry.
However, Health Secretary Duque said funding wasn’t the issue.
“There are funds. The problem there is [shortage in] the global supply [of testing kits]. That’s the number one challenge,” the health chief told ABS-CBN News.
Initially, the Philippines had to send samples from persons suspected of coronavirus infection to the Victorian Infectious Diseases Reference Laboratory in Australia for confirmation. Then, on Jan. 29, the RITM received RNA primers from Japan enabling it to identify the specific strain of the virus itself.
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