January 31, 2021 — Filipino scientist and UP Manila researcher Dr. Raul Destura who developed the local SARS-CoV-2 GenAmplify™ rRT-PCR test kit revealed during a forum that more laboratories are now using the local kit because of its lower price at P800 and high comparative concordance test results with foreign kits.

At the forum tackling the UP Manila PGH response to the COVID-19 pandemic held as part of the Science and Technology week, the director of the National Institutes of Health’s National Training Center for Biosafety and Biosecurity said that the further reduction of the cost from the initial P1100-1220 per test to less than P800 pesos were made possible due to the continued support of local testing centers by catering to the local kit. This is because they are now able to order more and negotiate for a lesser price. “Each time we succeed in reducing the price, we translate it directly to the cost of the technology,” he added. 

Concordance analysis studies done by independent laboratories through the support of the Department of Science and Technology compared the GenAmplify™ kit with other FDA- approved RT PCR kits. Results showed a kappa value of 0.866 demonstrating an almost perfect agreement within the ideal range of 0.81 to 1.00. Dr. Destura revealed that a lot of laboratories have already utilized the GenAmplifyTM COVID-19 rRT-PCR kit for proficiency testing and all of them or 100% passed the first time they submitted the results to the Research Institute for Tropical Medicine. 

“In our design, we wanted it to be quicker and easier to use that’s why it’s a one-step RT PCR kit development; in the laboratory, you just have to add the solution once the RNA is extracted and then run the PCR,” Dr. Destura explained. He added that the GenAmplify™ COVID-19 rRT-PCR kit Version 2.0 was created because Version 1.0 had problems with contamination coming from raw materials from supplier.

The Manila HealthTek Incorporated, the first University of the Philippine’s spin off company founded by Dr. Destura for the manufacture of his Biotek-M™ dengue aqua testing kit, is currently able to produce 8,000 to 10,000 GenAmplify™ COVID-19 rRT- PCR kits per day using an automated system that allows it to respond to the needs of the market. It distributes to many COVID-19 testing facilities all over the country. 

With increased use and recognition of the  GenAmplify™, Dr. Destura underscored that catering to Filipino-based technologies would not only provide Filipino scientists more opportunity to hone their skills in diagnostic technology research but will also improve our country’s competitiveness in the regional and global biotechnology landscape and help accelerate the growth of the health biotechnology ecosystem in the country. 

“Ultimately, if more biotech industries are being generated in the Philippines, it can support the macroeconomic growth of the country and provide job opportunities related to science and technology for our young talented graduates, instead of them leaving the country,” he declared. 

The multi-awarded scientist disclosed that they are now filing for a pre-analytic technology platform and will undergo field testing within the next two weeks for the SalivaFAST™ COVID-19 Self-collection saliva kit to be partnered with the GenAmplify™ COVID-19 rRT-PCR kit. This version used a different formulation of the saliva technology called the SalivaFAST™ which will remove a lot of steps and can run a direct PCR detection. 

According to him, this innovation is very convenient even for people at home to self-collect the platform and the solution is stable enough under room temperature for 14 days. As soon as field studies are completed, they will apply for FDA certification and once approved, they can release the kit sooner with the cost utilization part dramatically lowered further as it will remove a very crucial step which is the RNA extraction.

Charmaine Lingdas

Published in UP Manila Healthscape Special COVID-19 Issue No. 22