We are now living in an era when we can diagnose cancer from a drop of blood. Not only can we tell what kind of cancer we have, but we also predict whether we will get cancer in the future and whether it will recur.

Previously, a biopsy was the only way to diagnose cancer. Now, however, it is possible to identify the genetic characteristics of cancer from blood and choose a treatment that matches the genetic characteristics.

This is owed to the technology of cancer genetic diagnosis through liquid biopsy. Liquid biopsy analyzes nucleic acid fragments in blood, saliva, and urine to track the progress of diseases, including cancer, in real-time. Cancer cells release circulating tumor DNA (ctDNA) during proliferation.

IMBdx (In My Blood diagnostics) has a technology that identifies mutations in ctDNA in the blood through next-generation sequencing (NGS). In early April, the company was listed on the Kosdaq market with the highest competition rate ever in the bio-industry.

Korea Biomedical Review interviewed Professor Kim Tae-you of the Department of Oncology at Seoul National University Hospital, who led the domestic cancer treatment field as the chairman of the Korean Cancer Association, to learn about the background of the company he founded and the reasons for its growth.

Question: We are curious about how you, a doctor who treats cancer patients, started this company.

Answer: After Seoul National University Hospital was designated as a research center in 2014, the Ministry of Health and Welfare assigned me a research project to study whether cancer genome analysis can be used for diagnosis and treatment in the clinic. In particular, creating the Precision Medicine Center at Seoul National University Hospital made it possible to apply this research to clinical practice. As its director, I went to the American Association for Cancer Research (AACR), one of the U.S. cancer societies where liquid biopsy technology was introduced.

In the early 2010s, we did NGS testing with tissue, but we thought we could do it with blood instead of tissue, so we included it in a research project of the Ministry of Health and Welfare. The purpose of a research center is not just to do research but to use the results as a business model, so we started the company in 2018.

Q: As someone who used to treat cancer patients, it must not have been an easy decision to enter the diagnostic field.

A: Until 2018, only products from American companies, including Guardant Health and Natera, were available in Korea. However, because the test was not covered by health insurance, it cost a whopping 4 million to 5 million won ($3,007 to $3,758). Although it was necessary for cancer patients, I said to myself, “Is it worth paying this much?” So, I thought we should make it ourselves.

Moreover, the later a cancer is detected, the more likely it is that eight out of 10 people will die even if they are treated well. Only 20 percent, or one or two out of 10, are cured.

The earlier the cancer is diagnosed, the better the treatment. In recent years, many good weapons have emerged, such as targeted therapies and immuno-oncology drugs. As a clinician treating cancer patients, I wanted to find a way to diagnose cancer faster.

Q: Tell us about your platform.

A: To use targeted anticancer drugs in advanced cancer patients, you need to know their genetic mutations. We have a product called AlphaLiquid that simultaneously tests 118 cancer-related genes in a single blood sample to identify biomarkers for targeted therapy. We also have a precision medicine platform that targets the entire life cycle of cancer, including “CancerDetect” for early screening of patients at risk of recurrence due to MRD (Minimal Residual Disease) after surgery for stage 1-3 cancer and “CancerFind” for cancer screening in healthy people.

When cancer is diagnosed in stages 1, 2, or 3, surgery is performed, and 20 to 30 percent of patients recur within five years after surgery. Patients are tested every six months to know whether the cancer has recurred, and CancerDetect is an early detection method. With CancerDetect, you can tell within a month whether the patient will recur in one to two years. It is the first and only recurrence-monitoring product in Korea that predicts cancer recurrence by monitoring up to 500 monitoring variants.

CancerFind is a multicancer early diagnosis platform that helps you know if you have cancer. You can find out if you have cancer and which cancer you have just by taking a blood test without endoscopy or imaging during a comprehensive health checkup.

Q: We understand that the U.S. is ahead of Korea in cancer diagnosis technology using liquid biopsy. Is there any differentiating technology between IMBdx and its U.S. competitors?

A: There was no point in making the same product because there is already a leading product in the U.S. Although we use NGS, we reflect our patented technology in one or two ways to increase our competitiveness.

Q: What is IMBdx's unique patented technology?

A: Since the amount of ctDNA shed from cancer cells into the blood is tiny, it is essential to have a capture technology that captures every bit of it and puts it into the NGS machine. AlphaLiquid used IMBdx's unique technology that maximizes capture by adjusting reagents. Also, because the amount of NGS is so tiny, it usually reads the same region repeatedly 50,000 times, leading to many errors. Therefore, we need an algorithm that eliminates errors. We developed such an algorithm and minimized the error.

In the case of CancerDetect, the existing products genetically test the cancer tissue removed at the time of surgery, and only 16 out of 100 or 200 genes are selected, and PCR is performed to detect recurrence. However, we make a personal panel of all the families, 100 or 200 families, visible in the tissue genetic test, and test them all. It takes a little longer than 16, but the detection is better.

CancerFind is a technology that identifies the genetic and epigenetic characteristics of cfDNA by measuring the methylation pattern, which is an epigenetic change, and estimates the site of cancer occurrence. While U.S. products analyze 100,000 to 200,000 regions of the DNA code related to cancer in the body, we analyze the patterns of all 30 million cancer-related genes using IMBdx's unique AI analysis technology to estimate the primary site of cancer. Our technology can quickly identify cancer-related gene patterns even with trace amounts of ctDNA.

Q: How competitive is your solution price compared to U.S. companies?

A: Products developed in the U.S. are relatively expensive because they have undergone clinical trials. In our case, we were a latecomer. We added some additions to the existing technology. The validation and clinical trials were done in Korea, so it is relatively cheaper. Taiwan is our biggest partner, and according to them, Guardant's market share is gradually coming over to us. The performance is not inferior, and the price is competitive.

Q: As targeted and immuno-oncology drugs, which target cancer-causing mutated genes, have become necessary, genetic analysis tests are becoming more popular. We are curious if genetic analysis tests using liquid biopsies are covered by health insurance.

A: AlphaLiquid, CancerDetect, and CancerFind are covered by health insurance. The government has been covering NGS gene panel tests since 2017. However, due to the high cost of NGS tests, they were designated as a selective benefit (with a 50 percent co-payment rate for one test). As recently as the last year-end, patients could get a single NGS test for about 700,000 won. However, the Ministry of Health and Welfare revised the reimbursement notice for NGS-based gene panel tests last December, reducing the selective benefit.

The ministry maintained the co-payment rate at 50 percent for patients with advanced, metastatic, or recurrent lung adenocarcinoma but raised it to 80 percent for patients with other advanced, metastatic, or recurrent solid cancers (excluding lung adenocarcinoma), plasmacytoma, acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, myeloproliferative tumors, malignant lymphoma, and hereditary diseases.

Patients paid 750,000 won when the deductible rate was 50 percent based on the cost of 1.5 million won. However, when the co-payment rate was raised to 80 percent, the patient had to pay 1.2 million won. Many patients feel burdened because it is over 1 million won.

Q: Given the increasing number of targeted and immuno-oncology treatments, we wonder if the co-payment rate should have been lowered.

A: Many studies have already reported that precise diagnosis and treatment can reduce the number of cancers and the cost of treatment. Patients are also more productive, which reduces social costs. This is something that the government is overlooking.

Q: Compared to Guardant and others, IMBdx is a latecomer. What is your strategy for targeting the domestic and international markets?

A: The U.S. has been using liquid biopsy since 2014. It accounts for about 30 percent of diagnostic demand. It depends on the type of cancer, but three out of 10 U.S. cancer patients are treated with liquid biopsy. In Korea, however, it's about two or three out of every 100. We are still in the early stages and have a lot of work to do.

First, we will need more time in the domestic market for evaluation and certification as CancerDetect, which screens recurrent cancer early, was designated as a new medical technology. We are working to make it happen as soon as possible.

CancerFind, a non-reimbursed test for health screening, currently costs about 1 million won to screen eight cancers, which can be costly, so we plan to lower the price to 500,000 won for 20 cancers.

Based on these products, the overseas market will be centered on Taiwan, the U.S., Thailand, and Vietnam. We have a network in 24 countries and are preparing local offshoots in Japan and the U.S.

Another is the companion diagnosis service. We recently signed an MOU with AstraZeneca to provide companion diagnostic tests for the prostate cancer targeted therapy Olaparib. AstraZeneca is developing more than 20 targeted therapies besides Olaparib, so the companion diagnostic service will likely expand.

Q: You said that your goal is to bring the cost of CancerFind down to 500,000 won. When do you expect that to happen?

A: When we first launched the service, we diagnosed eight cancers for 1 million won, but now, by the end of 2026, we will detect 20 cancers for 500,000 won. We may issue a 500,000 won test coupon as a filial piety product at the end of 2026.

Q: If we can screen for over 20 cancers with blood, medical checkups with expensive equipment may disappear.

A: It's not a replacement for existing tests but rather a complement. For example, in the case of CT or colonoscopy, some older adults or people have difficulty doing it once every six months. For patients with difficulty with endoscopy or imaging, liquid biopsy can be used to check if they need to be re-tested after the existing test.

Q: If a general medical examination shows that there is no cancer, but a liquid biopsy shows that there is cancer, which test result should be followed?

A: Even if the cancer was not seen in the conventional test, the cancer genome may be diagnosed when the liquid biopsy is performed. In such a case, I would not reject it as overdiagnosis. Still, I would like it to be used as a way to manage your health, such as changing your lifestyle or having regular tests to detect cancer early because you may get cancer in two to three years. It’s like if we know we have high blood pressure, we take medication, we exercise, we manage it. Suppose conventional screening has a 50 percent success rate, and we can fill the other 50 percent with liquid biopsies to diagnose and treat cancer sooner. In that case, it won't be hard to conquer cancer.