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| Theragen Etex co-CEO Hwang Tae-soon speaks during an interview with The Korea Times at the genetic testing firm's lab in Suwon, Gyeonggi Province, on July 30. Courtesy of Theragen Etex |
Regulations hamper industry's bid to expand home test
By Nam Hyun-woo
SUWON, Gyeonggi Province ― Six years ago, actress Angelina Jolie revealed that she had a preventive double mastectomy, after genetic testing showed that she had a high risk of developing breast cancer.
In an opinion piece for the New York Times, she wrote the test showed she had an 87 percent risk of breast cancer, and she made the choice to reduce the chances. The risk fell from 87 percent to 5 percent after the surgery.
The actress' story boosted public awareness of genetic testing, which was already anticipated to be one of the most promising markets showing rapid growth.
In Korea, there are more than 10 companies, including Theragen Etex, providing genetic testing to help customers predict their chances of developing certain diseases. The companies believe in a future where genetic testing is not only a pre-step for tailored medical services but also a useful tool for non-medical industries, according to Hwang Tae-soon, co-CEO of Theragen Etex and chairman of the Korea Genome Industry Council.
"The ultimate goal for a company is knowing what customers want. And the answer lies in a person's DNA," Hwang said during an interview with The Korea Times. "Of course its priority is in medical and healthcare services, but its scalability is endless, empowering various industries."
Hwang, who spent more than 20 years of his career at info-tech companies including Cisco, said genome service providers will play a similar role as internet service providers do these days ― becoming the basis of new businesses.
"I'm not saying genome testing itself will revitalize industries. It will be a tool and an indicator for various other industries so they can expand their businesses and provide new services to customers," Hwang said.
"One example is the skincare industry. Through genetic testing, customers can find whether their skin is prone to wrinkles, pigmentation or acne in the future and apply preventive products, and this could be the case regarding food, automobiles, insurance and a slew of other industries," he said. "With genome data, companies can recommend products fitting each individual customer. And it is certain the number of applicable industries will grow exponentially, given the commercialization of genome data is in its infancy."
For the medical industry, genetic testing plays a core role of complementing the current symptom-based diagnosis and prescriptions. When accompanied by genetic tests, a drug's response rate goes up to 80 percent from 35 percent if the drug was prescribed based solely on a symptom-based diagnosis, Hwang said.
In a case reported in 2014 at Samsung Medical Center in Seoul, a 65-year-old woman diagnosed with brain cancer had surgery, but her condition worsened and she lost the ability to walk.
Doctors at the hospital, including Nam Do-hyun, conducted genetic tests on her brain cells and found a mutation in her EGFR gene, which is known to contribute to lung cancer. The doctors administered lung cancer treatment effective for the EGFR gene mutation to the patient, which led to noticeable improvements in her symptoms and brought back her ability to walk.
"You might experience that a certain drug works well for you but other drugs don't for the same symptom," he said. "When genetic testing is involved, the chances of such an inconvenience or problems will be reduced. You will have less drugs, pharmaceutical firms will be able to provide targeted medication and eventually the government will spend less on healthcare programs."
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| A Theragen Etex researcher demonstrates collecting a sample for genetic testing. Courtesy of Theragen Etex |
Distant dream
Hwang said not only Theragen Etex but also other domestic genetic testing service firms dream of a future where customers purchase gene testers and send data to the firms through devices installed at health and beauty or convenience stores, but that is a distant dream in Korea not because of technological limitations but regulations.
As technology advances, genetic testing is now available at home. For home testing, customers purchase testers through the internet or other retailers and send samples to the firms. Industry officials call this a "direct-to-customer (DTC) test" and believe it will play a crucial role in the expansion of genetic testing, because it is simple and convenient. It takes one minute to collect saliva with the tester.
In Korea, however, customers cannot get reports on the risks of developing cancer or other diseases with a home test, because Korean law prohibits firms other than medical institutions from conducting tests related to the prevention, diagnosis or treatment of a disease. To get results on critical diseases such as cancer, customers have to do the same test through hospitals.
What's available with a DTC test here is information on only 12 criteria including blood sugar, blood pressure, cholesterol, vitamin C and skin aging, which do not directly indicate the risks of developing cancer or other diseases.
The 12 criteria became available when the government lifted regulations in June 2016, a year after U.S. testing firm 23andMe celebrated its 1 millionth customer. Before 2016, genetic tests in Korea were available only at hospitals.
"Just three years have passed since the government allowed DTC tests on 12 criteria and promised to lift regulations on 45 other criteria," Hwang said. "We expected the government to allow the additional criteria at the end of this month, but not sure about whether it will be available because the government has come up with another certification system on genetic testing."
As genetic testing firms face what Hwang described as "mountains of regulations," the Ministry of Trade, Industry and Energy launched a "regulatory sandbox" in April and allowed four genetic testing firms ― Theragen Etex, Macrogen, DNA Link and Medizen Humancare ― to conduct tests on criteria they applied for.
But they are yet to conduct business. This time, the industry ministry told the firms to listen to the Ministry of Health and Welfare's guidelines, which imposes tougher conditions on genetic testing. Officials from the genetic testing industry claim that this is because hospitals and medical groups, which have a strong influence on the health ministry, are opposing to the expansion of DTC, which helps customers bypass hospitals.
"We don't want to defy the law and we are not asking too much," Hwang said. "To avoid additional setbacks stemming from the health ministry and medical groups' opposition to genetic diagnosis, Theragen Etex gave up criteria related to disease's diagnosis and applied for DTC tests on obesity. But the health ministry seems to be thinking tests on obesity and exercise ability are also a diagnosis of diseases."
As genetic testing firms cry foul over the delay, the government said "the two ministries are cooperating and are having consultations to support firms' DTC tests, and an additional certification system was one of the preconditions for genetic testing firms entering the sandbox."
"President Moon Jae-in and Prime Minister Lee Nak-yon seem to have the intention to lift regulations, but there seems to be stark differences at the working level," Hwang said. "There should be a balance between stability and growth, but it seems to have been broken in the genomics industry."
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| A researcher checks the results of a genetic test at Theragen Etex lab in Suwon, Gyeonggi Province. Courtesy of Theragen Etex |
