Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements
After the VALID Act didn't pass, it's uncertain how the FDA will proceed, though some payors aren't waiting for the status quo to change and asking labs to submit additional validation data on cancer tests.
Diagnostics Developer Early is Good Raises $4M in Seed Funding
The company will use the funds to complete clinical trials for its first product, BCDx, a laboratory-developed test for early bladder cancer detection.
The company will offer diagnostics including a test for the early detection of pancreatic cancer out of the lab as well as pharma research services.
The firm is aiming to commercialize its OncoPrism assay in 2023 as a laboratory-developed test to identify head and neck cancer patients eligible for checkpoint inhibitors.
Bionano Genomics Launches CLIA-Certified Laboratory, First OGM-Based Test
Bionano Laboratories will offer services to clinical customers seeking to implement OGM for routine diagnostic use.