IMBDX, 0.001% Ultra-Trace Cancer Detection 'World-Class Level'... Innovative Medical Review

Rapid Increase in Test Volume for Global Competitor Natera
"Value Will Be Recognized After Completion of Innovative Medical Technology Review"

IMBDX, a precision medicine company that analyzes genes in the blood to diagnose cancer early and provide customized anticancer treatment guides, announced on the 20th that it has submitted an application for the innovative medical technology review for CancerDetect, a test product that can detect cancer recurrence as early as three weeks after surgery.

Innovative medical technology is a system under the New Medical Technology Evaluation Project, which allows early use in clinical settings if the safety and potential of new technological products are recognized, according to the standards set by the Minister of Health and Welfare.

IMBDX's CancerDetect is a product that detects minimal residual disease (MRD) remaining after cancer surgery, enabling early confirmation of cancer recurrence to help achieve complete cure and ultimately improve patient survival rates. CancerDetect detects unique genetic mutations imprinted on the patient's cancer cells from the blood and possesses world-class accuracy capable of detecting these mutations even at a very low rate of 0.001%.

Kim Tae-yu, CEO of IMBDX, explained, "When CancerDetect is introduced to the medical field for the first time in Korea, it will proactively classify surgical patients according to their risk of recurrence. For patients with a low risk of recurrence, unnecessary anticancer treatments will be reduced, and for patients in whom minimal residual disease is detected, active anticancer treatment will be recommended early."

He added, "By managing the risk of recurrence, it is expected to reduce the mortality rate caused by cancer recurrence across society and decrease social costs spent on unnecessary anticancer treatments."

Global competitor Natera from the United States, specializing in minimal residual disease recurrence detection, reported a 58% growth in performance in the second quarter of this year compared to the same period last year. The number of tests also increased by about 50%, reaching 125,000 cases. IMBDX's CancerDetect is also expected to be fully recognized in the market once it is actively applied in clinical practice after the completion of the innovative medical technology review.

This content was produced with the assistance of AI translation services.