MANILA, Philippines – The long wait is over.
The Food and Drug Administration (FDA) on Friday, April 3, issued a certificate of product registration to the coronavirus test kit developed by the scientists from the University of the Philippines-Manila National Institutes of Health (UP-NIH).
"The test kit was previously approved by the FDA for field trial with gene sequencing on March 1-10, 2020. Upon the company's submission of necessary requirements today, the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use," FDA Director General Eric Domingo said in a statement.
The locally-made test kits can accommodate up to 120,000 tests and are capable of fast detection of coronavirus in samples taken from patients. The results can be ready in two hours.
To be prioritized for manufacturing are 1,300 test kits funded by the Department of Science and Technology and the UP-NIH project that would accommodate 26,000 of those tests. They will be distributed to the following hospitals from April 4 to 25:
The remaining kits good for 94,000 tests will be sold by Manila HealthTek at around P1,300 per kit, 6 times cheaper than its foreign counterpart which costs around P8,500. (READ: Where are testing centers for coronavirus in PH?)
As of Friday, the health department has accredited 9 laboratories to conduct coronavirus tests, while at least 66 others are being prepared to handle tests.
The FDA also announced that it has approved one additional rapid test kit today. So far, the Philippines has a total of 30 COVID-19 polymerase chain reaction (PCR)-based and antibody rapid test kits for commericial use.
As of Friday, the Philippines has 3,018 confirmed cases of coronavirus, with 136 deaths and 52 recoveries. Globally, the virus has infected more than 1 million people, with over 53,000 deaths. – Rappler.com