FDA approves Covid-19 test kit developed by Filipino scientists

HAWAII. Hawaii state Department of Health microbiologist Mark Nagata demonstrates the process for testing a sample for coronavirus at the department's laboratory in Pearl City, Hawaii on Tuesday, March 3, 2020. (AP)
HAWAII. Hawaii state Department of Health microbiologist Mark Nagata demonstrates the process for testing a sample for coronavirus at the department's laboratory in Pearl City, Hawaii on Tuesday, March 3, 2020. (AP)

THE Food and Drug Administration (FDA) has allowed the use of a detection kit developed by Filipino scientists to test samples from patients under investigation for the coronavirus disease (Covid-19).

In a press statement, the agency issued a Certificate of Exemption for the Sars-CoV-2 PCR Detection Kit, developed by scientists of the University of the Philippines-National Institute of Health (UP-NIH).

Sars-CoV-2 is the official name given to the novel coronavirus by the International Committee on Taxonomy of Viruses.

Development of the technology is funded by the Department of Science and Technology.

"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," FDA Director General Eric Domingo said in a statement.

FDA added that the detection kit "will be used for field testing coupled with gene sequencing at the Philippine Genome Center."

"We salute our scientists that continue to serve the people in the best way they can. We also urge the UP community and the public to call for immediate state funding for the mass production of the kits, once approved with finality, to aid in the resolving of the health crisis at hand," the UP Office of the Student Regent said in a Facebook post on Tuesday, March 10.

The Department of Health (DOH), however, did not indicate during the budget hearing Tuesday morning, March 10, whether it is going to source some of its test kit requirement from UP.

On Monday, March 9, President Rodrigo Duterte declared a public health emergency following the confirmation of Covid-19 cases in the country.

To date, there are 24 confirmed Covid-19 cases in the Philippines.

"Twenty-four lahat as of last count, but the transmission is going on kasi may mga bago nadagdagan. So, that is how bad it is," Duterte said Monday evening, March 9.

The DOH said there is no need to declare a lockdown since no community transmission has been confirmed yet.

DOH Assistant Secretary Maria Rosario Vergeire said a lockdown is a preventive strategy enclosed in Code Red sub-level 2 alert which will be declared upon confirmation of sustained community transmission.

The Covid-19 threat in the country is still under Code Red sub-level 1 after the DOH reported the first case of local transmission, a 62-year-old man who has no travel history.

On Tuesday, March 10, the House committee on appropriations approved a bill providing a P1.65-billion supplemental fund to help combat the spread of Covid-19. This is more than half of the P3.1 budget requested by DOH.

DOH Undersecretary Roger Tong-an said their requirements are as follows: P2 billion for personal protective equipment, P933 million for the operating expenses and salaries of additional Bureau of Quarantine personnel, and P139 million for 40,000 test kits for the Research Institute for Tropical Medicine.

Funds are to be sourced from Philippine Amusement and Gaming Corporation (P2 billion), DOH savings (P539 million), Philippine Charity Sweepstakes Office (P420 million), and DOH quick response fund (P81 million). (RJL with SunStar Philippines)

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