UriFind is a non-invasive, quantitative real-time PCR (qPCR) assay, designed to detect bladder cancer using urine specimens from suspected patients, and was granted the US FDA Breakthrough Device Designation (BTD)
AnchorDx, a China-based developer of cancer early detection solutions, has recruited the first patient in the US clinical study of its UriFind bladder cancer assay.
The clinical trial aims to evaluate the performance of its assay in more than 1,000 patients across multiple sites, including 10 Urology clinics and three CAP/CLIA laboratories.
UriFind is a non-invasive, quantitative real-time PCR (qPCR) assay, designed to detect two DNA methylation biomarkers in urine specimens from patients suspected of bladder cancer.
In July last year, the assay was awarded the US Food and Drug Administration (FDA) Breakthrough Device Designation (BTD).
The company intends to use results from the clinical trial to support its application with the US FDA, seeking Premarketing Approval (PMA) for the assay.
AnchorDx chief scientific officer Marina Bibikova said: “The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the US.
“Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high-performing test for the detection of bladder cancer.”
Bladder cancer is a common type of cancer with a high recurrence rate, and the majority of bladder cancer cases are urothelial carcinomas.
Cystoscopy, followed by biopsy of suspicious lesions, is the gold standard for diagnosis of both new and recurrent bladder cancer, which is highly invasive and expensive.
AnchorDx claimed that its UriFind is a urine-based, non-invasive molecular test that will deliver accurate detection of bladder cancer.
The assay is said to offer superior sensitivity and specificity than cytology and other assays and offers advantages in the detection of early, micro, residual and recurrent bladder cancer.
UriFind has completed the registered clinical trial in China and was granted China’s National Medical Products Administration (NMPA) priority review in August this year.
The test has also been granted CE certification in the European Union (EU).
AnchorDx founder and chief executive officer Jian-Bing Fan said: “AnchorDx is committed to transform early detection and diagnosis of cancer as we continuously bring our tests into clinical practice through clinical validation.
“We are collaborating with leading urologists worldwide to gain important clinical evidence on the use of our UriFind test. This clinical trial represents an important step towards commercialization of the test in the US.”