GenCurix to Expand Breast Cancer Prognostic Diagnostic Kit to Hospitals in Second Half... Domestic Sales to Begin in Earnest

[Asia Economy Reporter Hyunseok Yoo] Kyobo Securities analyzed on the 8th that GenesWell BCT, a breast cancer prognosis diagnostic kit by GenCurix, will generate full-scale domestic sales next year. No investment opinion or target price was presented.

GenCurix was established in 2011. The company is developing the breast cancer prognosis diagnostic kit GenesWell BCT and the lung cancer companion diagnostic kit Droplex EGFR.

Junghyun Kim, a researcher at Kyobo Securities, said, "GenesWell BCT, the breast cancer prognosis diagnostic kit, obtained approval from the Ministry of Food and Drug Safety in November 2016 and received innovative medical technology approval in November 2020, completing preparations for domestic sales." He added, "Currently, administrative procedures such as IRB approval are underway for kit sales in general hospitals, and the number of hospitals able to sell the kit will increase in the second half of this year, leading to full-scale domestic sales starting next year."

There is also potential for expansion into China. He stated, "Regarding overseas expansion, plans to enter China have been somewhat delayed due to COVID-19, but high demand for breast cancer prognosis diagnostics in China has already been confirmed, and recently Chinese regulatory authorities have significantly relaxed regulations on breast cancer prognosis diagnostics." He continued, "As a result, regulatory approval is not required for kit launch, enabling early business entry." He further explained, "In Japan, the goal is to obtain approval within three years, and clinical results conducted locally in Japan this year will be announced."

He also emphasized the need to consider companion diagnostics and early diagnosis businesses. Researcher Kim said, "Companion diagnostics include diagnostic kits for lung cancer and colorectal cancer, and particularly the lung cancer kit is already in the process of having insurance reimbursement rates decided and increasing the number of registered hospitals." He stressed, "For early diagnosis of colorectal cancer and liver cancer, product development and internal efficacy verification have been completed, and clinical trials for approval are being prepared."