CNN보고, 어떻게 한국회사는 Coronavirus 확진자검사 Kit를 3주만에 먼저 생산할수 있었던가. 연구진들의 노력의 대가.

한국은  우리 모두가 다 알고 있고 치를 떨고있는 고질병, 그것 한가지만 빼고는 모든 분야에서 세계정상을 차지하는 독보적인 존재를 확인시켜주는 유용한 뉴스들이 그나마 경제폭망과 Coronavirus전염병으로 심신이 지쳐있는 국민들에게 커다란 위안이 되고 있다고 하겠다.

며칠전에는 미스터트롯 경연대회의 최종 우승자 "진"을 발표했는데, 거기까지 오는 3개월여 동안, 많은 국민들에게, 웃음을 선사해주는, 그래서 Energy를 충전시켜주는 보약같은 역활을 해줘서, 그기간동안에 침체되여 있는 국민들에게 환한 웃음을 선물로 안겨줬었던, 기억에 오래남을 Entertainment가 있었는데, 이프로그람 역시 한국의 연예계가 세계의 정상임을 보여준 사례였었다.

Coronavirus 감염여부를 확인하는, Testing Kits를 한국의 Biotech사들이 발명하여 실용단계에 들었다는 뉴스를 CNN을 비롯한 전세계의 뉴스미디아들이 앞다퉈 보도하고 있다. 지금같은, 전세계가 전염병 확산을 막기위해 전전긍긍하고 있는 Covid-19전염여부를 간단하게 시험할수있는 Package를 개발하여, 한국은 물론 전세계로 수출까지 하고 있다는 뉴스가 국민들에게 많은 위안을 줄것 같다.

오늘 뉴스에 의하면 캐나다와 미국간의 국경도 완전 폐쇄하여, 화물물동량, 꼭 필요한 사람들의 출입국만을 허용한다고 발표했다.  이런 징조로 봤을때는 Coronavirus전염병은 수그러들 기미가 없다는 증거이기도 하다.

한국은 현재 4개 회사가 지난 1월부터 Test Kits개발에 착수했다고한다. 여기서 더 발전하여 치료할수있는 약품까지개발한다면, 더이상 세상사람들이 걱정할 필요가 없어지고, 거의 올 스톱되여 있는 경제활동이 원래의 위치로 되돌아갈수 있는, 인류사회에 페니실린을 처음 발명했을때의 기쁨 그이상으로, 커다란 획을 하나 더 긋는 경사라고 볼수 있을 것이다. 꼭 그렇게 되리라 믿는다.

현재  다른 나라에서는 확진자 확인을 위한 충분한 테스트 킷트를 확보하기위해 고군분투하고 있는데, 한국에서는 무료로 보급하고, 의사들이 검사가 필요하다고 하는 환자들이 쉽게 접근할수있게 됐다고 한다. 질병본부(KCDC)발표에 의하면, 검진할수있는 시설이 118개 있으며, 검사결과는 모두 KCDC에 보고하도록 되여있다. 지금까지 Test Kits를 이용하여 검진한사람은 230,000이다.  이시설들중에는 운전하면서 검진할수있는 시설도 있는데, 그곳에는 보건요원이 방역복을 입고 운전자를(drive-through coronavirus testing )직접 체크해준다고 한다.

"조기 환자 발견은 매우중요하다. 한국은 개방된 사회로 사람들의 여행이 자유롭게 유지되기를 좋아한다. 그래서 운전자가 직접 차에서내리지 않고도 검진할수있는것이다."

이러한 검진을 위해서는 Test Kits가 필수적으로 필요한 것이다. 

Seoul (CNN)Before there were any cases of novel coronavirus confirmed in South Korea, one of the country's biotech firms had begun preparing to make testing kits to identify the disease.

On January 16, Chun Jong-yoon, the chief executive and founder of molecular biotech company Seegene, told his team it was time to start focusing on coronavirus.

That was before the virus sweeping China had been named Covid-19 and four days ahead of South Korea confirming its first case.

"Even if nobody is asking us to, we are a molecular diagnosis company. We have to prepare in advance," he remembered thinking at the time.

Fast forward two months, and South Korea is among the world's worst affected countries, with more than 7,800 people infected, and more than 60 deaths.

But one reason why South Korea might have a higher number of infections than other countries is its aggressive approach to testing.

While some nations have struggled to get enough test kits to diagnose suspected patients, South Korea has provided free and easy access to testing for anyone who a doctor deems needs it. The country's Centers for Disease Control & Prevention (KCDC) says the country has 118 facilities that can test -- and all report their results to KCDC. To date, the country has tested more than 230,000 people.

It has even rolled out drive-through coronavirus testing facilities, where motorists are met by health workers dressed in hazmat suits.

"Detecting patients at an early stage is very important," South Korea's health minister Park Neung-hu told CNN Monday. "South Korea is an open society and would like to protect the freedom of people moving around and traveling.

"That is why we're conducting mass amount of tests."

But to roll out tests en masse, a country first needs test kits. 

A secret weapon

In the basement of Seegene's headquarters in Seoul lies the key to the company's coronavirus success.

There the company houses an artificial intelligence-based big data system, which has enabled the firm to quickly develop a test for coronavirus.

Tests known as assay kits are made up of several vials of chemical solutions. Samples are taken from patients and mixed with the solutions, which react if certain genes are present.

Without the computer, it would have taken the team two to three months to develop such a test, said Chun. This time, it was done in a matter of weeks.

By January 24, the scientists had ordered the raw materials they needed for the test kits. Four days later, they arrived. On February 5, the first version of the test was ready.

It was only the third time the company had used its super computer -- rather than its research and development team working manually -- to design a test. It had previously used the system to make diagnosis kits for urethritis, the inflammation of the urethra. The company was able to design the test using only the genetic details that had been released about the virus, and without having a sample of Covid-19.

And it didn't require his teams to work around the clock. Only a few people needed to be involved, said Chun.

The next hurdle was getting the test approved for use. It can take a year-and-a-half to submit the necessary documents to South Korea's authorities and get it approved.

This time, it took a week.

Lee Dae-hoon, who led the team of scientists working to develop the coronavirus test kit, has spent his whole life working on diseases. He's never seen the KCDC approve a test kit so fast.

On February 12, Seegene got sign off, thanks to KCDC expediting the process. It was only then that the scientists only knew for certain that their test worked, as the government had evaluated the test using their own patient samples.

Getting the kit to hospitals

By mid-February, South Korea's coronavirus cases had spiked dramatically. On February 23, the country's President Moon Jae-in raised the country's crisis alert to the highest level.

"We're now at a watershed moment with the novel coronavirus and the next few days will be very critical," Moon said in a televised address. "We need to identify the infected people as soon as possible and prevent the virus from spreading further."

Following that, Chun made a snap decision. His 395 employees would drop all other work and focus on making coronavirus test kits. Production of the company's 50 or so other products temporarily ceased for two weeks.

"Emergency operation means all of the divisions, you have to change your job," he said. "All of our teams are focusing on coronavirus product development."

That means micro molecular biologists with PhDs have had to drop research and development to take a seat on the assembly line.

"Some times (senior scientists are) doing packaging of the product. It doesn't matter how they are educated, it doesn't matter because we are crazy here," said Noh Si-won, the executive director of corporate strategy.

Seegene is one of four domestic companies providing coronavirus test kits in South Korea.

But the company is also facing international demand from about 30 countries -- including Italy and Germany -- some of which are using Seegene's products on patients, Chun said.

At first, Seegene struggled to meet demand, but now it is coping.

The firm is making about 10,000 kits a week and each kit can test 100 patients. So it is making enough to test one million patients each week, at a cost of under $20 per test.

Noh Si-won, the executive director of corporate strategy, said it is the first time he has seen the company manufacturing at this scale.

The company has three months' worth of stock of other test kits, so it can meet demand for its preexisting orders for a month or two. But Chun said it was important for the company to continue making coronavirus test kits -- and the need goes beyond financial gains.

"We have to be providing or contributing one way or the other to figure it out as soon as possible. That's why (we supply to) the whole world," he says.

What other countries are doing wrong

In other countries, the authorities have struggled to keep up with the demand for testing.

Chun says one possible explanation is that some places may be testing manually, rather than automatically.

All tests start with a nurse taking a swab or a sample from a patient. If the swab is tested manually, a scientist will use a pipette to put the assay kit onto the sample.

But in a growing number of places -- including South Korea -- scientists are using automatic testing.

Rather than a human mixing the solutions, the samples are instead put into a diagnostic machine.

Inside the machine, a robot arm pipettes the solution and mixes the liquids on a number of tests at once. According to Chun, this method takes only four hours to test samples from 94 patients -- four times faster than the manual method. It also reduces the risk of human error or contamination.

The other thing that could be slowing some countries down is the type of test kits being used. There are three genes that can be tested for to confirm coronavirus -- and Seegene's kits are able to test for all three genes in one tube, said Chun. That's not necessarily the case for all test kits.

Chun believes if the United States had access to Seegene's system, the country could test 1 million patients a week. But for now, the US isn't using the test on patients -- it doesn't have approval from the US Food and Drug Administration (FDA).

Chun wants to help health authorities overseas.

"The issue is they have no chance to test the people properly," he said. "Without the proper diagnosis, nobody knows what's going on."

지난 15일 대전 유성구에 있는 진단키트 개발 회사 솔젠트. 일요일인데도 유재형 대표를 포함해 전체 직원 3분의 2에 해당하는 30여명이 출근해 우한 코로나 바이러스 감염증 진단키트 생산에 한창이었다. 유 대표는 매일 아침 8시에 출근해 새벽 2~3시가 넘도록 해외에서 밀려드는 계약 문의 전화를 받느라 정신이 없다. 20~30국에서 하루 100통 넘는 상담 전화가 쏟아진다고 한다. 유 대표는 "휴일과 밤낮없이 하루에 18~20시간 일한 지 두 달이 돼간다"고 했다. 솔젠트의 작년 매출은 60억원 정도인데 최근에만 중국·미국 업체와 80억원 규모의 수출 계약을 체결했다. 진단키트 개발 업체 씨젠도 비슷한 상황이다. 씨젠 관계자는 "연구소 직원까지 생산에 동원되고 있다"고 했다.

하루 13만명을 6시간 만에 검사할 수 있는 한국의 우한 코로나 바이러스 진단 능력에 해외가 주목하고 있다. 미국 방송사 CNN은 "일부 국가에서는 진단키트를 얻기 위해 고군분투하고 있지만, 한국은 무료로 쉽게 검사할 수 있다"면서 국내 업체 연구시설을 소개하기도 했다. 이처럼 국내 진단키트 업체들이 주목받는 것은 메르스·에볼라·신종 플루를 겪으며 노하우를 쌓았고, 빠른 의사 결정이 가능한 박사·교수 출신 전문가가 회사를 이끌기 때문에 가능하다는 분석이다.

◇中에서 감염자 정보 뜬 뒤 바로 착수16일 현재 식품의약품안전처에서 판매 허가를 받은 곳은 5개 업체다. 이 중 4개 업체가 진단키트를 대량 생산해 국내 수요를 맞추고 해외 수출에 나서고 있다. 코젠바이오텍이 지난달 4일 식약처로부터 가장 먼저 긴급사용 승인을 받았고, 씨젠은 같은 달 12일 승인을 받았다. 4개 회사는 일주일에 10만~50만명 분량의 진단키트를 생산하고 있다.



https://www.propublica.org/article/how-south-korea-scaled-coronavirus-testing-while-the-us-fell-dangerously-behind 

https://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-testing-intl-hnk/index.html


https://biz.chosun.com/site/data/html_dir/2020/03/16/2020031603854.html

https://www.propublica.org/article/how-south-korea-scaled-coronavirus-testing-while-the-us-fell-dangerously-behind