[INTERVIEW] Amsbio CEO on the making of Korea's most accurate Covid test
Park Hye-rin, the founder and CEO of Amsbio, didn't think it would be possible to reach 100 percent accuracy in detecting coronavirus infections.
But during a test administered by the Ministry of Food and Drug Safety (MFDS) for emergency use authorization, the company’s Covid-19 molecular diagnostic kit scored 100 percent sensitivity and 100 percent specificity.
Although it could be extremely difficult to replicate the laboratory result in the real world, it's still a notable feat — one that separates Amsbio from the other Korean companies that have developed Covid-19 tests.
The diagnostics manufacturer gained approval in May and now exports the tool that takes 53 minutes to process the result.
The Korea JoongAng Daily sat down with Park to discuss the stories behind the development of the company's test kit.
Q. What factors do you think allowed this test to be so successful?
A. It has been 20 years since Amsbio started researching diagnostic reagents. We started off developing diagnostic tools to detect animal diseases such as African Swine Fever and foot-and-mouth disease.
But the size of the diagnostic reagent market is small, and even if a company manages to pass the strict clinical trial process, what they make from the diagnostic test kit is only in the hundreds of millions of won.
Still, developing a test kit requires a high level of technical abilities, not to mention the long time needed to earn a regulatory nod. So, we couldn’t make a profit for 12 years, but continued to invest in research and development. Building on the research, we were also able to manufacture equipment for making diagnostic kits. The accumulated expertise and knowledge helped the company provide a quality Covid-19 test kit.
Q. Could you describe the process to gain approval from the MFDS?
A. The MFDS put in place three criteria to be met for emergency use authorization. First, the test should be carried out in one hour. Second, more than 95 percent sensitivity. Third, the capability to report "weak positive" cases, where a very small amount of the virus is found in the sample. These are quite tough conditions to meet, even if you compare it with the standards installed by the drug authorities in advanced economies like the United States and Europe.
So, it takes 23 minutes for our testing kit to extract ribonucleic acid (RNA) from a swab sample and another 29 minutes to run the polymerise chain reaction (PCR) tool to amplify the extracted RNA and then the final one minute to identify whether the extraction contains the virus. So, the full process takes 53 minutes.
In the sensitivity test, 42 positive samples and 42 negative samples are given. So we detected 100 percent correctly for the virus and gave a negative result for 100 percent of the samples without the virus. A trickier part is the third criteria to determine weak positive cases.
It is relatively easy to differentiate those with the virus and those without. But detecting people with a tiny amount of the virus poses a higher level of challenge. In the third round, we were required to identify 30 percent of weak positive samples. So the test goes with 30 strong positive samples, 12 weak positive and 42 negative. But the Amsbio kit verified all samples correctly at once, which translated into 100 percent specificity.
Q. Amsbio manufactures its diagnostic tool in a plant in Yeoju, Gyeonggi. What made you decide to establish the plant in the region?
A. I know many other diagnostics companies are without full-fledged manufacturing facilities, and they didn't conform to the factory management guidelines recommended by the authorities. The lax standards typically lead to problems in quality and cause complaints from clients. I was lucky to recognize the importance of those standards for managing plants, as I own pharmaceutical and cosmetics companies. The Yeoju plant was established last year, but it took several months to adjust the facility according to the Good Manufacturing Practices (GMP) guidelines. That is why we were late coming into the market.
Q. How many of the Covid-19 testing kits can the facility produce?
A. It is capable of manufacturing 1.2 million kits in a month, which is enough to carry out 120 million tests. In one day, it can make 40,000 kits that could handle 4 million tests.
Q. Where do you export the approved product?
A. We have signed contracts in two countries — though we can’t specify — and are in the middle of discussing a deal in about 10 countries in the Middle East, Asia and Europe. Amsbio’s test kit already won a CE mark from the European Union and filed an application for approval from the U.S. Food and Drug Administration.
BY PARK EUN-JEE [email@example.com]
with the Korea JoongAng Daily
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