Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Diasorin Nabs FDA 510(k) Clearance for Gram-Negative Bloodstream Infection Panel
The firm's Liaison Plex Gram-Negative Blood Culture Assay is used for the identification of 19 Gram-negative bacteria and eight resistance genes.
Inbiome Nabs IVDR Certification for 'Molecular Culture' Bacteria Test
The Amsterdam-based firm's PCR-based Molecular Culture ID test is used to detect more than 200 bacterial species, yielding results within five hours.
Genomic Testing Cooperative Gets UKCA Marks for Cancer Assays
The UK Conformity Assessed marking covers the company's sequencing-based assays for solid tumors and hematologic neoplasms.
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.
Federal Court Vacates FDA Rule on Laboratory-Developed Tests
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.