MANILA, Philippines — The use of GenAmplify rapid testing kits for the coronavirus disease 2019 (COVID-19) has been suspended due to a contamination issue on the raw materials used in their manufacture, Science and Technology Secretary Fortunato dela Peña announced yesterday.
Dela Peña, at a Laging Handa online press briefing yesterday morning, said that a new round of validation for the test kits manufactured by Marikina City-based health technology startup Manila HealthTek Inc. of Dr. Raul Destura was required before these could be used again.
“So when the new materials came in, we required a new validation through our RITM (Research Institute for Tropical Medicine) and eventually FDA (Food and Drug Administration),” said Dela Peña.
He said that while Manila HealthTek Inc. was continuing to produce thousands of kits per day for the mass testing program, the testing has been halted while validation was being done.
“So while the Manila HealthTek is producing 6,000 tests (a day), it is waiting for a clearance again from FDA. (This is) another round of clearance. Because of the new shipment of the materials that we have,” Dela Peña said.
“But the production itself is hitting 8,000 tests per day,” Dela Peña assured.
Dr. Jaime Montoya, executive director of the DOST-Philippine Council for Health R&D which provided substantial funding for the successful research of the UP Manila team of scientists led by Destura, said the problem was rooted in the supplier of raw materials.
He said production of the kits has been stopped.