FDA submission
Arquer Dx Developing Urine-Based Protein Biomarker Tests to Detect Bladder, Endometrial Cancers
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Arquer's assays use mouse monoclonal antibodies to detect levels of MCM5 proteins in cells exfoliated into urine to detect either bladder or endometrial cancers.
Tempus Submits PMA Application for Tumor Profiling Assay to FDA
The firm has submitted companion diagnostic and tumor profiling, and MSI status claims using DNA from FFPE tumor tissue and matched normal specimens.
Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer
The assay is intended to detect
Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib
The DRP would be used to identify kidney cancer patients likely to benefit from dovitinib, a repurposed TKI for which Allarity plans to file an NDA this year.
Meridian Bioscience Submits Curian Campylobacter Assay to FDA
The test runs on the firm's Curian rapid fluorescent immunoassay and detects four species of a common foodborne pathogen.