Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
Clinical researchers at AACR discussed a wide range of approaches focusing on several different potential use-cases in the detection or assessment of early cancers.
The company is seeking NY State approval for its lab, which would allow it to offer both tests as LDTs, hopefully by the end of this year or early next.
The test uses qPCR to measure the methylation level of three bladder cancer-specific biomarkers in patient urine samples.
According to the researchers, the method could enable higher-throughput analyses while removing some of the subjectivity inherent in pathology practice.
The breath-based biopsy firm is collaborating with Renji Hospital to conduct a clinical trial into the early detection of lung cancer in China.
Sienna Cancer Diagnostics said today that it has signed an agreement making Mediwell a non-exclusive distributor of its bladder cancer diagnostic in Singapore.
Sienna's in vitro diagnostic is designed to detect the hTERT component of telomerase, a biomarker that aids in the diagnosis of bladder cancer.
MicroMedic's CellDetect assay detects early-stage urothelial bladder cancer in about 20 minutes using a unique plant-based dye.
The firm is preparing to launch a clinical trial for the AdxBladder test in the US early in 2019 and use the results to apply for 510(k) clearance with the FDA.