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.
According to the researchers, the method could enable higher-throughput analyses while removing some of the subjectivity inherent in pathology practice.
Sienna Cancer Diagnostics said today that it has signed an agreement making Mediwell a non-exclusive distributor of its bladder cancer diagnostic in Singapore.
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.
