Genomictree is on the threshold of advancing to the U.S. market for non-invasive diagnosis of colon cancer estimated to be hundreds of billions of won. The start of this company with high potentials traces back to the early 2000s. The government encouraged establishing new businesses at the time, leading to the births of healthcare startups like mushrooms after a rainfall. One of such firms was Genomictree. About two decades have since passed, and those who still exist are few and far between. Rarer still are companies that directly target the U.S. market, as Genomictree is doing now.

Genomictree’s weapon to infiltrate into the U.S. market is EarlyTect Colon Cancer. It is a new, non-invasive and real-time polymerase chain reaction (PCR) test of colorectal cancer by measuring biomarker methylated from stool DNA, SDC2 (Syndecan-2). The company is planning to conduct related clinical trials in the United States next year.

Korea Biomedical Review met with CEO An Sung-whan recently and heard from him about the company’s business strategy, including its plan to advance to the U.S. market.

EarlyTect Colon Cancer received a third-degree approval as non-invasive medical equipment in Korea last August. It has also won patents for a unique methylated biomarker for diagnosing colorectal cancer and its detecting methods, in the U.S., Europe, China and Japan.

Question: We are curious how Genomictree was set up.

Answer: In the early 2000s when a startup boom swept Korea’s healthcare industry, there were words that the environment was ripe for starting businesses, which encouraged me to come back to Korea and set up Genomictree. Right after the company’s founding, however, the venture boom was over, causing difficulties in attracting investment. Fortunately, I could start a business with small amounts of money from family members, acquaintances, and angel investors.

To survive, we first focused on making and selling microarray DNA chips and producing sales by conducting researches on commission. Genomictree’s ultimate target, however, is the U.S. market, then or now. We never stopped research and development, and our efforts have born fruits, as seen by EarlyTect and other hit products.

Q: What difficulties did you experience in developing EarlyTect?

A: While we were developing EarlyTect, a body fluid-based method to detect colon cancer in the early stage, the hardest thing was finding out biomarkers, which might exist in body fluids, from cancer tissues.

In the early stages of development, the domestic environment left us with no other options but to find out diagnostic biomarker directly through translational research, and prove its usefulness on our own. Those were hard times, indeed. We set up a goal and direction to reach it, however, and spent time on accumulating experiences and know-how. We still are endeavoring to develop a non-invasive diagnosis of cancer at an early stage, and the current research team has come to know in which direction to move and what attempts to make. The joint work of these people constitutes the core competency of Genomictree.

Q: How would you evaluate EarlyTect’s competitiveness compared with the existing U.S. products?

A: Currently, Genomictree’s major competitors are Germany-based Epigenomics and the U.S. Exact Sciences. When the market was formed, Epigenomics got the limelight.

Epigenomics used the method called liquid bioassay, which diagnoses cancer by using cell-free DNA, a circular cell-derived DNA that moves around in the blood.

People have gene segments in their blood, and genes can be detected from body fluids. The same principle applies to cancer cells. However minuscule the DNA in the blood may be, we can find it by targeting a specific marker. That biomarker should be the marker that exists in all stages of cancer and should be able to be found in the precancer stage if researchers are lucky.

Epigenomics’ products won approval with 70 percent of sensitivity and 80 percent of specificity. However, Cologuard, which was the product of Exact Sciences, received the nod with 92 percent of sensitivity and 87 percent of specificity, achieving an enormous success to be ranked at seventh or eighth place in the entire U.S. molecular diagnostic market.

Exact Sciences recorded the sales of 530 billion won ($450 million) last year.

As seen in this case, the growth potential of this market is huge provided we can have the technology to diagnose specific types of cancer at an early stage and in non-invasive ways.

EarlyTect’s trial results show both its sensitivity and specificity reach 90 percent, similar to Exact Sciences’ product. Moreover, Genomicstree has the advantage of independent measuring and developing methods, making it further competitive.

Q: Please you explain in greater detail the difference between EarlyTect and Exact Sciences’ product?

A: The most noticeable difference is they have different biomarkers. Testing methods are similar. Both products use a stool for examination. However, our product judges it positive if there is a biomarker, and negative if there is no biomarker. Cologuard has a larger number of biomarkers to examine, taking more time (about eight hours for EarlyTect vs. about 26 hours for Cologuard). The amounts of feces used are different, too, between them. EarlyTect uses walnut-sized stool while Cologuard uses the entire amount of excrement. That means EarlyTect is more economical concerning cost-effectiveness.

Q: We heard the number of subjects is about 9,000 for phase 3 clinical trials prepared by Genomictree. Usually, phase 3 trials for new drug requires about 3,000 participants. Why should you need three times higher number of subjects than usual?

A: There are no uniform standards for the number of subjects for clinical trials in the U.S. In the case of non-invasive diagnostic products, the number of participating patients differs depending on which types of cancer it aims to diagnose at an early stage. Clinical trials with screening purposes to diagnose colorectal cancer at an early stage require forward-looking tests composed of 9,000-10,000 participants. The reason we advance to the U.S. among all overseas markets is the U.S. non-invasive diagnosis market is most extensive and most valuable. We will push for advances to Europe and other markets at the same time as we launch clinical trials in America.

Q: Have you chosen U.S. partners?

A: We are preparing for clinical trials to win the U.S. Food and Drug Administration’s approval next year, and have hired local experts (needed for the tests) to this end. For the U.S. trials, we should do various things within this year. We are currently contracting three contract research organizations in the U.S., and discussing future cooperation, including trial designs and recruiting participating patients. The U.S. trials are likely to proceed smoothly, barring unexpected problems. We are planning to look for other partners for copyrights and marketing while conducting tests.

Q: What are outlooks for non-invasive diagnosis market for colorectal and other cancer in the U.S.?

A: Exact Sciences have decided to make a business deal with Pfizer. The global pharmaceutical giant’s jumping into this sector means it has judged it an up-and-coming market. Early diagnosis of cancer is a crucial means for leading a healthy life and improving the quality of life through healthcare. Treatments are an area which inevitably accompanies a gradual increase in medical expenditure. Even now, multimillion-dollar therapies are coming to the market, but early detection and elimination of cancer will play a significant role in saving medical costs. That also explains why Exact Sciences is faring well in the U.S. market.