Geneomictree said Thursday that it has completed patient recruitment for its confirmatory clinical trial of EarlyTect-B, an in vitro diagnostic for bladder cancer.

EarlyTect B is a new type of in vitro molecular diagnostic for the early detection of bladder cancer.

According to Genomictree, EarlyTect-B can accurately diagnose bladder cancer by measuring “PENK” methylated DNA, a biomarker for early diagnosis of bladder cancer present in urine, using a real-time PCR gene amplification method. It is also used for early diagnosis of patients with hematuria who have never had bladder cancer and are at high risk of it.

The company is conducting the EarlyTect-B clinical trial in two phases -- exploratory and confirmatory.

In the exploratory trial, the company said EarlyTect-B performed better than the comparator test, NMP22. As a result, the number of confirmatory trial subjects has been revised from 3,453 patients to 1,249 patients, which is within the range of statistical significance.

By modifying the trial enrollment, the company said it could avoid the ethical issues and clinical inefficiencies associated with over-enrollment.

A company official said that patient recruitment for the confirmatory trial is complete, and Genomictree plans to submit a license application to the Ministry of Food and Drug Safety next year.

"Early identification of which patients with hematuria should undergo cystoscopy is a very important factor in utility," CEO Ahn Sung-hwan said. "If the clinical validity of EarlyTect-B is proven, it will be very helpful in diagnostic utility for bladder cancer in the future."

The confirmatory clinical trial will be conducted at 10 hospitals nationwide, including Seoul National University Hospital, Asan Medical Center, Korea University Anam Hospital, National Cancer Center, and Samsung Medical Center, affiliated with the Korean Urological Oncology Society in patients with hematuria aged 40 and older who are scheduled to undergo cystoscopy.