The US Food and Drug Administration (FDA) has granted breakthrough device designation for Pangea Laboratory's Bladder CARE Assay.
This non-invasive assay is designed for the quantitative detection of bladder cancer using urine samples, and upper tract urothelial carcinoma (UTUC) in patients with haematuria.
It addresses the urgent need for non-invasive and reliable diagnostic methods, particularly for UTUC, which is often associated with bladder cancer but has a poorer prognosis and was previously only detectable through invasive procedures.
The CE-marked IVD test utilises a single quantitative polymerase chain reaction (qPCR) reaction to measure the methylation levels of three DNA biomarkers specific to urothelial cancer.
It can also detect the presence of high and low-grade bladder cancer tumours, as well as identify the cancer cells at a minimum concentration of 0.046% in samples of urine.
The assay significantly surpasses traditional cytology and other tests approved by the FDA, demonstrating sensitivities and specificities of 93.5% and 92.6% for bladder cancer detection, 96% and 88% for UTUC, and 89% sensitivity for carcinoma in situ.
Pangea Laboratory founder and CEO Dr Larry Jia said: “The FDA's recognition of the Bladder CARE Assay validates its potential to reshape cancer diagnostics, making effective and patient-friendly detection a reality.”
The company is now preparing to initiate multicentre clinical studies, which is the subsequent step in seeking premarket approval for the assay.
Pangea Laboratory project manager Dr Paolo Piatti said: “The breakthrough results from a successful collaboration with Dr Siamak Daneshmand and Dr Hooman Djaladat and their teams at USC Urology.
“We anticipate further fruitful partnerships with experts in the field to enhance the accessibility of the Bladder CARE Assay.”
Established in 2014, Pangea Laboratory is a diagnostics company that focuses on the sensitive, early, and non-invasive detection of critical health conditions.
This year, an estimated 82,290 individuals in the US were diagnosed with bladder cancer.
