Cancer, the number one cause of human deaths, is no longer a life-threatening disease when detected and managed early enough. Excluding lung cancer, pancreatic cancer, and gallbladder cancer, the five-year survival rate of cancer when detected early ranges from 95% to 100%, according to the Ministry of Health and Welfare and the National Cancer Center's “National Cancer Registration Statistics 2015.”
According to the Health and Welfare Statistics Year Book 2019, 78,200 people (154.3 out of every 100,000 people) died of cancer last year, which has been the number one cause of death since 1983. In addition, according to data from the National Cancer Center in 2018, if Koreans live up to their life expectancy (82 years old), the chance of cancer is 36.2%, which is more than one in three persons.
Unigenebio has completed the development of a kit that can predict and detect advanced cancer of seven major cancers: lung cancer, liver cancer, stomach cancer, colon cancer, pancreatic cancer, breast cancer, and prostate cancer, as well as precancer, microcarcinoma, and metastatic cancer. It is currently applying for five patents. I met the inventor of the diagnostic kit, Lee Wang Jae, a professor at Seoul National University, College of Medicine.
- What are the development motive, background, and completion date of the prognosis and diagnosis kits (ROOCUT KIT-7) for the 7 major cancers?
The earlier cancer is diagnosed, the higher the survival rate. Early diagnosis of cancer examines the condition of the cancer gene in the pre-cancer stage before cancer outbreaks and predicts the occurrence of cancer, ultimately preventing it through active response from occurring. The development of molecular diagnosis technology has enabled early prediction and diagnosis through cancer gene testing.
Unigenebio, which has the best level of cancer gene analysis diagnosis technology, had pushed for the development of seven major cancer prognosis and diagnosis kits in order to dominate a huge market of early cancer diagnosis that is just taking place, and completed the development of kits for PCR in October 2019 and applied for five patents.
- Due to COVID-19, interest in diagnostic kits has increased in both Korea and foreign countries. But the cancer prognosis and diagnosis kit is still unfamiliar to the general public, so what exactly is it?
Like the COVID-19 diagnostic kits, cancer prognosis and diagnosis kits are unavailable to use by the general public themselves. It is an in vitro diagnostic device that predicts and diagnoses the occurrence of cancer by examining the expression of cancer-related genes in the blood of an individual's sample from a medical institution.
- What are the technologies and features of the 7 major cancer prognosis and diagnosis kits?
Unigenebio's seven major cancer diagnostic kits (ROOCUT kit-7) examine infinitesimal circulating tumor cells (CTCs) in the blood or genetic fragments left by CTCs to predict the occurrence of cancer. This kit not only predicts the outbreak of various cancers but also its location by algorithmizing the occurrent properties of gene expressions of different cancer types since each cancer genes vary depending on which organ it appeared in. "ROOCUT" is short for "ROOT CUT," meaning "extermination of cancer."
- What does the development of ROOCUT kit-7 mean to the medical industry and consumers?
The current cancer diagnosis market is for the treatment of patients with already developed cancer. Both the market for early diagnosis of cancer (precancer or invisible cancer) before the occurrence and the market for recurrence and metastasis prevention for cancer survivors remain vacant. A huge market for early cancer prognosis and diagnosis is now opening, and through a new predictive diagnostic service that consumers have not been able to benefit from, the way to predict and prevent cancer before it occurs has opened.
- It seems like many companies are developing cancer diagnostic kits. What's the current situation?
Currently, the only cancer prognosis and diagnosis kit released on the market is the colorectal cancer diagnosis kit released by Exact Sciences in U.S. and Genomictree in Korea. Kits that most companies are developing now are at a level where only one type of cancer is detected and even if multiple is diagnosed, it cannot specify exact locations (affected organs). Therefore, it is expected that our products, which can specify many types of cancers up to its locations, will lead the market in the future.
- You have applied for 5 patent applications, what are the main contents and what will it mean when the registration is complete?
Patent applications are for the technologies related to CTCs manifestation and diagnostic algorithms, diagnostic equipment, and generic technologies related to diagnostic prognosis systems. Once the patent registration is completed, it will secure technological superiority and monopoly status when entering overseas markets. It will make a full-fledged inroad into foreign markets including China through a sole distributor, Misotree.
- Any future plans related to the technology in fields of domestic and international certifications, sales, inspection agencies, and continuous research?
In addition to the certification of new health technology, we are planning to carry out procedures for certifications from FDA Korea, FDA U.S., CE Europe, and FDA China. In the first half of this year, we will also open the ROOCUT Clinic, a "genetically prognosis VIP cancer management hospital," which will prevent cancer prevention, metastasis, and recurrence through scientific follow-ups.
