CLIA
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.
If the Center for Genomic Interpretation's in silico quality assessment catches on with payors, some labs are sure to push back or propose data sharing as an alternative.
Pillar Biosciences Gets CLIA Certification for Sequencing Clinical Lab
The company said the certification would enable it to support preclinical studies and clinical trials, as well as to potentially provide companion diagnostics.
Oncocyte Shares Tank on News of Delayed CLIA Validation Study for Liquid Biopsy Lung Cancer Test
The firm said it needs more time to ensure that the DetermaVu assay is providing the most consistent and sensitive results for patients.