Genomictree, a company specializing in biomarker-based cancer diagnostics, said on Wednesday that it launched its bladder cancer diagnostic product, EarlyTect-BCD, in the U.S.

Accordingly, the launch will be carried out by Promis Diagnostics, a U.S. subsidiary of Genomictree, as a laboratory developed test (LDT) service at its CLIA LAB.

LDT is an in vitro diagnostic test service that is performed only by the laboratory that developed the test. Consequently, CLIA LAB certification is an essential prerequisite for launching this diagnostic service in the U.S. as an LDT.

The CLIA LAB certification process, which is a standard accreditation for laboratories in the U.S., is administered by the Center for Medicare & Medicaid Services (CMS), which sets out laboratory requirements and testing service guidelines to control test quality, and oversees the accreditation process.

Promis Diagnostics is equipped with its own College of American Pathologists (CAP) certified specimen analysis center and has previously provided Covid-19 diagnostic services to California using a similar LDT service.

EarlyTect-BCD is a product that diagnoses bladder cancer with high accuracy by measuring the methylation of a specific site of the 'PENK' gene, a biomarker for early diagnosis of bladder cancer, in the urine of patients with hematuria by real-time gene amplification.

Hematuria is a typical symptom of bladder cancer where blood appears in the urine, but only 5-20 percent of patients with hematuria are diagnosed as bladder cancer patients. Currently, cystoscopy, the standard test for bladder cancer, places an endoscope into the urethra, causing great discomfort to the patient. Additionally, this method also has low sensitivity, so there is a high unmet medical demand for more accurate products, explained a Genomictree official.

Previously, the device was designated priority status in the FDA Breakthrough Device Program in April.

This designation is granted to innovative technologies that show preliminary clinical evidence that a medical device provides a more effective diagnosis or treatment compared to currently used devices for life-threatening diseases.

The program aims to accelerate development, evaluation, and review while maintaining regulatory standards to ensure that innovative medical devices are available to patients and providers promptly.

"We have initiated LDT services to accelerate the delivery of EarlyTect-BCD to patients and healthcare providers in need of early detection of bladder cancer," said Justin Lee, Head of Business Strategy and Operations at Promis Diagnostics. "We plan to take advantage of the FDA's Breakthrough Therapy Device designation to accelerate full FDA approval."