Philippine-made test kits approved for commercial release
The Philippine-made GenAmplify COVID rRT-PCR detection kit is now ready for commercial distribution after the Manila HealthTek team worked with DOH experts to address issues in the earlier kits.
Michael Varcas

Philippine-made test kits approved for commercial release

Pia Lee-Brago (The Philippine Star) - July 20, 2020 - 12:00am

MANILA, Philippines - The Philippine-made, low-cost “gold standard” test kits for coronavirus disease 2019 (COVID-19) are finally ready for commercial use, the Department of Health (DOH) said yesterday.

“We, at the DOH and DOST (Department of Science and Technology), are proud of our homegrown scientists who continue to use their talent to benefit not only the Filipino people but the rest of humanity as well,” the DOH said in a statement.

The DOH cited the Manila HealthTek team’s commitment to excellence and safety, as they worked closely with an independent laboratory expert panel in addressing key issues of version 1 of GenAmplify.

“After several months of collaboration, we are proud to say, GenAmplify version 2, the country’s very own RT-PCR test kit, is finally ready for commercial use,” the DOH said.

“We now have our very own RT-PCR (reverse transcription-polymerase chain reaction) test kit, ” it said.

As with other medical products and devices, the DOH said the performance of the kits would be regularly monitored.

Dean Rowena Cristina Guevara, science undersecretary for research and development, said they are looking at a July 2021 timetable for procurement of the vaccine with any of the foreign partners.

Guevarra, also chair of the Inter-Agency Task Force on Emerging Infectious Diseases (IATF) sub-Technical Working Group (TWG) evaluating the international collaborations for the development of a COVID-19 vaccine, said they expect the vaccine to be available by July 1.

“That is our target procurement date. By August, the vaccines will arrive here. That’s August next year,” Guevara told The STAR in a telephone interview.

She explained that the Universal Health Care Act requires that for any vaccine to be procured by the government, it must have undergone Phases 3 and 4 clinical trials with a foreign institutional partner.

The TWG is giving a clinical trial period of up to seven months, estimated to end by March 31, 2021, she said.

There is also a minimum period of 60 days for registration of the vaccine.

Guevara stressed that the government would only procure the vaccine for frontliners.

“Everyone, all the others, will have to pay on their own,” she said.

The vaccine would cost between P500 and P2,000, depending on how many doses one will need, she added.

Budget for vaccine

Senate Majority Leader Juan Miguel Zubiri said the Senate would fund in the proposed 2021 national budget the purchase of COVID-19 vaccine that would be commercially available next year.

Zubiri said allocations for fighting COVID-19, retooling the country to adjust to the pandemic and reviving the economy would be the main thrusts in crafting next year’s national budget.

“Having a vaccine is very important, and it appears that there will be a vaccine by October or September, because there are two companies that will come out with them. We need to put that in our 2021 budget so we can purchase them for our 107 million Filipinos,” Zubiri told dzRH.

Senators prodded the DOH and the Food and Drug Administration to speed up approval of locally made COVID test kits, which are cheaper.

Sen. Joel Villanueva said the slow pace in accrediting kits developed in the University of the Philippines “speaks volumes about the mismanagement” in the DOH.

“The test kits have been ready since May, and yet we continue to rely on imported test kits that cost significantly higher than the locally manufactured ones,” Villanueva said. Rainier Allan Ronda, Paolo Romero

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