As the technology to analyze biomaterials develops, blood diagnosis quickly expands its presence in the cancer diagnostic market.
Traditional diagnostic firms developed various technologies for diagnosing diseases using various body fluids, such as urine and sweat. In recent years, however, many companies have started to use blood as it contains all the biometric information such as proteins, DNA, and RNA.
Bertis, a local bio-venture company, is one of such companies leading the cancer diagnostic market using blood. The company has already made considerable progress, as it developed and launched Mastocheck, a medical device, which can diagnose breast cancer using only a single drop of blood, in 2019.
The company expects that if cancer diagnosis using blood becomes more common, it will significantly help patients detect cancer at home at a relatively low cost without using expensive test equipment.
Korea Biomedical Review met with Bertis CTO Kim Sung-soo to talk about Mastocheck and the company's short- and long-term goals.
Question: A solution that can diagnose breast cancer with a single drop of blood seems unique. How does the device work?
Answer: Mastocheck detects breast cancer early by inserting three unique protein biomarkers' quantitative value, closely related to breast cancer in the blood, to our proprietary algorithm.
Mastocheck adopts the principle of measuring proteomic markers in the blood with their mass values. Such a method allows diagnosis based on the intrinsic mass of a molecule without antibodies and quantifies dozens of different proteins simultaneously in a single analysis.
The medical device also requires only 1 ul (microliter), which is less than a drop of blood, to make the diagnosis.
Q: What are the advantages of Mastocheck compared to conventional breast cancer screening methods?
A: The most significant advantage is that it is a blood test. Blood tests are simple, painless, and objective.
Hospitals currently use imaging diagnosis to detect breast cancer. However, mammography, the most common breast cancer screening method, compresses the breast, resulting in pain and discomfort. Also, the accuracy varies depending on the performance of the device or the reader.
In the case of dense breasts, which most Asian women have, it is difficult for the hospitals to get an accurate reading.
Therefore, if hospitals use Mastocheck, they can check the result through an objective numerical value rather than the reader's subjectivity while keeping the accuracy consistent regardless of the breast density.
The company believes that the device can supplement existing test methods' limitations and play a valuable role in the current medical system.
Q: Can Mastocheck detect and distinguish all types of breast cancers?
A: The current Mastocheck focuses on early screening at this stage, and it is challenging to distinguish breast cancer subtypes.
However, the company aims to develop markers that can help determine breast cancer subtypes and establish treatment strategies in the future.
To this end, we are conducting clinical trials with various subtypes in mind, and we are continuing to advance breast cancer diagnosis through developing our next version, Mastocheck 2.
Q: What is Mastocheck 2, and are there any other devices that the company is developing?
A: The company developed Mastocheck 2 based on various data to improve accuracy and reflect doctors' detailed needs. We plan to submit a review to the Ministry of Food and Drug Safety within this year.
Bertis is also developing early detection markers for pancreatic cancer and cardiovascular.
Ultimately, the company aims to build a platform that will allow hospitals to diagnose dozens of diseases with just one blood test.
Q: After obtaining approval for Mastocheck in 2019, What are some memorable feedback from doctors and patients the company has received?
A: Patients who used Mastocheck gave back a lot of positive feedbacks, saying that the device is comfortable to take and painless.
Some medical professionals stressed that Mastocheck is a checkup that even young women in their 20s and 30s can easily receive.
Women in these age groups are experiencing a high incidence of breast cancer. However, they rarely receive breast screenings due to radiation exposure.
Therefore, Mastocheck is useful for young women and those who need to avoid radiation exposure.
Q: Could you tell future prospects why they should choose Bertis' Mastocheck?
A: As I explained earlier, if blood tests are added to the existing test method of imaging diagnosis, it is possible to produce much accurate and reliable test results.
Therefore, Mastocheck will be of great help to medical staff and examinees.
Notably, the device is a handy test method for medical workers. It is a more accessible test method in various aspects such as safety, convenience, and economic efficiency, especially for patients with dense breasts and young women in their 20s and 30s.
Q: What are Bertis' vision and ultimate goals?
A: In the short term, we seek an initial public offering (IPO) in the second half of this year, and are considering making aggressive overseas expansion focusing on the U.S. market, which has high demands.
Our long-term goal is to become the world's top quantitative proteomics company in clinical practice.
Ultimately, Bertis hopes that its simple diagnosis method will lead to the early treatment of breast cancer and become a company that contributed to promoting public health.