FDA submission
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.
Fujirebio Seeks to Expand Alzheimer's Test Portfolio With FDA Submission for β-Amyloid Ratio Assay
Premium
The firm said that a US FDA clearance would broaden the adoption of its growing portfolio of diagnostic assays for Alzheimer's disease.
Fujirebio Diagnostics Applies for FDA 510(k) Clearance for Alzheimer's Disease Test
The firm said that its test uses cerebral spinal fluid to produce a numerical ratio of β-Amyloid1-42/ β-Amyloid1-40, and runs on its fully automated Lumipulse G1200 instrument system.