Genomictree's "EarlyTect-B" Receives Class III Manufacturing Approval from MFDS for Bladder Cancer In Vitro Diagnostic Test

Genomictree, a company specializing in molecular diagnostics for cancer, announced on January 8 that it has officially obtained Class III manufacturing approval from the Ministry of Food and Drug Safety for its in vitro molecular diagnostic medical device for bladder cancer, "EarlyTect-B."

"EarlyTect-B" is a diagnostic product developed in-house by Genomictree's research and development team, utilizing "PENK DNA methylation," a bladder cancer biomarker discovered and validated through extensive translational research. It applies LTE-qMSP, a high-precision DNA methylation measurement technology, to develop a non-invasive urine test for bladder cancer diagnosis.

This manufacturing approval is significant because it is based on objective results with statistically proven clinical efficacy from a large-scale, prospective, multi-center confirmatory clinical trial. The confirmatory trial involved 10 university hospitals nationwide, including Seoul National University Hospital, and was conducted on a total of 1,097 patients with microscopic or gross hematuria scheduled for cystoscopy.

They evaluated the performance of "EarlyTect-B" using the results of tissue biopsies following cystoscopy as the standard reference. The primary objective of the confirmatory clinical trial was to assess the diagnostic performance for "clinically significant high-grade or invasive bladder cancer." In the final analysis, "EarlyTect-B" demonstrated excellent performance, recording a sensitivity of 89.1%, specificity of 87.8%, and negative predictive value of 97.7%. These figures represent a dramatic improvement over existing tests such as NMP22 (sensitivity 51.5%) and urine cytology (40.1%), and are expected to set a new standard for urine-based molecular diagnostic technology for bladder cancer.

The most common early sign of bladder cancer is painless hematuria. Microscopic hematuria, frequently detected during health checkups, is very common and can be found in approximately 2.4% to 31.1% of the general adult population. Gross hematuria, visible to the naked eye, also occurs frequently among adults. However, the proportion of hematuria patients who are actually diagnosed with bladder cancer is relatively low, at around 10%.

Currently, in clinical practice, if persistent hematuria occurs, cystoscopy is performed first to rule out the possibility of bladder cancer, and if abnormalities are found, tissue is collected for biopsy to confirm the diagnosis. However, this process inevitably leads to unnecessary cystoscopy procedures for patients who do not actually have cancer. In addition, the diagnostic efficiency at the initial stage is insufficient, as the confirmation rate of cystoscopy, the standard diagnostic method, is not high. This diagnostic structure causes inconvenience and financial burden for patients and is regarded as a representative example of unmet medical needs that require urgent improvement.

In this clinical context, "EarlyTect-B" provides a key basis for reducing unnecessary cystoscopy procedures by demonstrating a high negative predictive value in clinical trials. Its high sensitivity also suggests that it can improve the detection rate of bladder cancer at the cystoscopy stage. In particular, its clinical utility is significant in enabling earlier detection of high-grade bladder cancer at an early, clinically meaningful stage. This is expected to provide real clinical value by allowing for early-stage diagnosis and immediate therapeutic intervention.

An Sungwhan, CEO of Genomictree, emphasized, "An innovative medical device must demonstrate true value by being effectively utilized to solve major issues raised in actual clinical settings, not merely by incorporating advanced machinery or new technologies." He also evaluated, "This unprecedentedly large-scale and high-quality clinical trial is a meaningful achievement that proves the outstanding research capabilities and international competitiveness of domestic urology medical professionals."

The company expressed its expectations, stating, "Among the adult population in Korea, there are millions of individuals with microscopic or gross hematuria. For high-risk patients experiencing persistent microscopic hematuria or gross hematuria, the clinical utility of 'EarlyTect-B' will be fully realized when used in conjunction with cystoscopy and tissue biopsy."

The company added, "Since bladder cancer has a very high recurrence rate, we plan to actively pursue clinical development for expanded application as a recurrence monitoring test in the future."