The US Meals and Drug Administration (FDA) has granted breakthrough gadget designation for Pangea Laboratory’s Bladder CARE Assay.
This non-invasive assay is designed for the quantitative detection of bladder most cancers utilizing urine samples, and higher tract urothelial carcinoma (UTUC) in sufferers with haematuria.
It addresses the pressing want for non-invasive and dependable diagnostic strategies, notably for UTUC, which is commonly related to bladder most cancers however has a poorer prognosis and was beforehand solely detectable by means of invasive procedures.
The CE-marked IVD check utilises a single quantitative polymerase chain response (qPCR) response to measure the methylation ranges of three DNA biomarkers particular to urothelial most cancers.
It may additionally detect the presence of excessive and low-grade bladder most cancers tumours, in addition to establish the most cancers cells at a minimal focus of 0.046% in samples of urine.
The assay considerably surpasses conventional cytology and different assessments authorized by the FDA, demonstrating sensitivities and specificities of 93.5% and 92.6% for bladder most cancers detection, 96% and 88% for UTUC, and 89% sensitivity for carcinoma in situ.
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Pangea Laboratory founder and CEO Dr Larry Jia stated: “The FDA’s recognition of the Bladder CARE Assay validates its potential to reshape most cancers diagnostics, making efficient and patient-friendly detection a actuality.”
The corporate is now getting ready to provoke multicentre scientific research, which is the next step in searching for premarket approval for the assay.
Pangea Laboratory undertaking supervisor Dr Paolo Piatti stated: “The breakthrough outcomes from a profitable collaboration with Dr Siamak Daneshmand and Dr Hooman Djaladat and their groups at USC Urology.
“We anticipate additional fruitful partnerships with consultants within the subject to boost the accessibility of the Bladder CARE Assay.”
Established in 2014, Pangea Laboratory is a diagnostics firm that focuses on the delicate, early, and non-invasive detection of essential well being circumstances.
This yr, an estimated 82,290 people within the US had been identified with bladder most cancers.