A TEST kit for coronavirus developed by Filipino scientists has cleared the first hurdle at the Food and Drug Administration (FDA), and is seen to boost efforts to contain the spread of the virus through timely detection.
The said project is funded by the Department of Science and Technology (DOST-Philippines) through the Philippine Council for Health Research and Development (DOST-PCHRD).
The SARS CoV-2 PCR Detection Kit technology was developed by local scientists led by Dr. Raul V. Destura from the University of the Philippines-National Institute of Health (UP-NIH). The kit will be used for field testing coupled with gene sequencing at the Philippine Genome Center.
The DOST also helped Destura in forming his spin-off company Manila HealthTek.
Science Secretary Fortunato T. de la Peña said the DOH-FDA called a meeting on March 9 to proactively look for alternative options to enhance ongoing efforts in testing suspected cases. This is an opportunity given by FDA for proponents of technologies to present their findings and ongoing validations.
The meeting, however, does not imply FDA endorsement.
This is the fastest and legal way to have access to technology under a state of emergency. This can empower testing centers to be able to test cases.
De la Peña said the test kit developed by the team led by Destura was presented at the March 9 meeting.
This research program actually included the dengue diagnostic kit, leptospirosis kit, etc. Destura’s technology spin-off company, Manila HealthTek, produces local diagnostic kits.
UP owns the intellectual property. Manila HealthTek was licensed.
During the March 9 meeting, the FDA gave a certificate of exemption (COE) instead of product certificate of registration to allow UP NIH to use the test kit under the category of field validation—also to be funded by DOST.
This validation category will prevail until a WHO validation is obtained.
Until this WHO validation is obtained, FDA requires an additional layer of risk mitigation measure. This means that the first 500 tests will involve a parallel sequencing technology with the help of the Philippine Genome Center in UP Diliman. This will be at no additional cost to the patient, de la Peña explained.
The FDA emergency use approval will also provide access to private hospitals with PCR capability to be involved.
The DOST-supported UP NIH test kit, which is produced by Manila HealthTek, will cost P1,320 per test. It includes the P200 for RNA extraction. The current cost for the foreign counterpart is at the P8,000 level. The required genetic sequencing is part of the validation cost, which is on top of the test cost.
The available 6000 tests now can be made available in three weeks—1,000 this week; 2,000 next week, 3,000 week after next.
An additional 20,000 tests can be made available after that. The cost for the first 2,625 tests is already covered by available DOST funds.
De la Peña said the remaining P34.6 million still has to be sourced from funds to be allocated to address the COVID-19 epidemic.