Next&Bio, a company specializing in organoid-based drug discovery, said on Monday that its pancreatic cancer drug susceptibility test has been designated an innovative medical technology. 

The company said that the test had become Korea’s first organoid-based innovative medical technology, paving the way for organoids to be used in clinical practice.

The National Evidence-based Healthcare Collaborating Agency (NECA) evaluated the device as a safe technology with a high potential to assist in the optimal selection of drugs by checking the susceptibility to cancer drugs before chemotherapy for pancreatic cancer.

The test cultures organoids using a very small amount of cell tissue collected by fine needle biopsy (FNB) from pancreatic cancer patients and checks the sensitivity of the organoids to different chemotherapy drugs. 

Pancreatic cancer still does not have clear biomarkers for selecting optimized cancer drugs for patients. Next&Bio developed the test to help patients choose the optimal drug for themselves with only a minimally invasive tissue test.

The Ministry of Health and Welfare Innovative introduced the medical technology assessment system in March 2019 to assist in the early market entry of innovative medical technologies. The designation allows the device to be used as a screening device, partially insured or uninsured in the domestic medical field once the hospital registers to use the device. 

"This approval allows organoids to be used in the clinical field in earnest and opens the way for patients with pancreatic cancer to choose the optimal anti-cancer drug," Next&Bio Co-CEO Yang Ji-hun said. "We plan to continue introducing organoid-based tests by expanding this device for other cancer types, such as lung and colon cancer, to further accelerate the realization of precision medicine based on organoid technology."