[Edaily Reporter Kim Jinsoo ] “Multiple Cancer Early Detection (MCED) must evolve into a test that more people can undergo regularly, rather than a one-time, expensive procedure. The key to making it widely accessible is incorporating it into corporate health screening programs and establishing a pricing structure that allows the general public to undergo the test annually or at regular intervals.”

Kim Tae-yu, CEO of IMBdx, Inc.(461030), stated in a recent interview with E-Daily, “Since the prevalence of cancer is very low in actual screening, the positive predictive value (PPV), false-positive rate, prediction of the primary site, and the process from a positive result to actual confirmation are crucial. We will lower the price of the test to improve accessibility while simultaneously demonstrating its performance in real-world screening settings.”

IMBdx, Inc. is a liquid biopsy company that offers CancerFind for early cancer diagnosis, AlphaLiquid to assist in treatment selection, and CancerDetect to track residual cancer and recurrence after surgery. According to CEO Kim, CancerFind—commercialized in 2023—has expanded its supply network to more than 120 screening centers nationwide.

CancerFind is priced between 800,000 and 1 million won depending on the institution and screening program, which has made it financially burdensome for the general public to use regularly. In response, IMBdx, Inc. plans to launch an affordable version, “CancerFind FIRST,” this October to expand its market into general health screenings as well as corporate and group screenings. At the same time, the company aims to build trust by verifying CancerFind’s performance among asymptomatic screening populations through the “PRECISE” prospective study, which will recruit 3,000 participants from 10 hospitals nationwide.

Screening with “FIRST”… High-Risk Groups Referred for Detailed Testing

CancerFind FIRST utilizes seven genomic traits obtained through whole-genome sequencing (WGS), excluding DNA methylation analysis from the existing CancerFind test. This approach streamlines the analysis process to reduce costs and processing time. The final price has not yet been determined.

CEO Kim stated, “Given the price of the existing CancerFind, liquid biopsy cancer diagnosis was inevitably confined to a market centered on premium screenings.” He added, “Our goal is to launch CancerFind First at a competitive price to enter not only general health screenings but also corporate and group screenings. After launch, as the volume of tests increases and automation and analysis efficiency improve, there is also the potential to continuously lower prices through economies of scale.”

In particular, he explained, “The screening process is designed in two stages. After broad-based screening with CancerFind First, high-risk individuals will be referred to the existing CancerFind precision test. The secondary test will perform a detailed analysis—including methylation data—and predict the primary site of cancer origin, with the aim of reducing the number of patients who unnecessarily proceed to imaging or endoscopy.”

IMBdx, Inc. is currently conducting a prospective study involving 3,000 participants using its MCED product. Through this study, the company plans to establish clinical reliability and analyze how CancerFind performs in the actual population undergoing asymptomatic health screenings. Participant recruitment began in August of this year, and approximately 2,700 of the 3,000 participants will be subject to long-term follow-up.

CEO Kim stated, “Key evaluation metrics include positive predictive value, false positive rate, primary site prediction, and the follow-up diagnostic process. We will analyze the proportion of individuals who tested positive but were later confirmed to have cancer, as well as the rate at which cancer-free individuals are falsely identified as positive. In screening populations with low cancer prevalence, a critical factor is determining how often a positive result actually leads to the detection of cancer.”

The study also accounted for the costs of follow-up diagnostic tests for those with positive results. This is significant because it allows for systematic tracking of the specific types of cancer actually detected following a positive signal.

He added, “While the ability to detect cancer at an earlier stage than with existing screening methods is important, confirming that this ultimately leads to a reduction in mortality requires a larger sample size and long-term follow-up. We plan to sequentially disclose interim results through academic conferences and other channels once sufficient enrollment and follow-up data have been secured.”

IMBdx, Inc. is also closely monitoring global regulatory changes. On the 23rd (local time), the U.S. Food and Drug Administration (FDA) Advisory Committee issued a positive opinion on Grail’s MCED test, “Gallery,” increasing the likelihood of FDA approval.

CEO Kim stated, “Whether ‘Gallery’ is approved could serve as an important precedent demonstrating the criteria the FDA will use to evaluate the new field of MCED testing.” He added, “This means we must demonstrate clinical benefits in the actual screening population as well as the subsequent diagnostic process. Given the possibility that future regulations for MCED testing may shift from the current genetic testing certification to medical device licensing, we will prepare for these changes through the PRECISE study.”

In addition, IMBdx, Inc. plans to develop an entry strategy for the U.S. market after accumulating prospective data and commercialization experience in Korea and Asia, taking into account U.S. regulatory standards and local partnerships. The company aims to expand the number of covered cancer types to 15 this year by adding small cell lung cancer, thyroid cancer, and gallbladder and bile duct cancers, and to 30 by 2030, including blood cancers.

CEO Kim said, “I believe it is important not simply to increase the number of cancer types, but to gradually include cancers that offer significant added value in actual screening,” adding, “The key challenge is securing sensitivity, specificity, and the ability to predict the primary site at a level that is actually usable for each cancer type, rather than focusing on the number 30 itself.”