regulatory approval
MRC Holland Gets CE-IVDR Certification for Phenylketonuria Detection Test
The company expects to bring its other assays through the same pathway in the upcoming year, ensuring access ahead of the IVDR's mandatory compliance deadline.
NeoGenomics Wins New York State Approval for Solid Tumor, Lung Cancer NGS Tests
Although the approval is conditional, the company can now offer the tests for physicians and patients in the state.
Guardant Health Liquid Biopsy CDx Gets Japanese Regulatory Approval for Janssen Lung Cancer Drug
Patients with inoperable or recurrent NSCLC and EGFR exon 20 insertion mutations may be eligible for Janssen Pharmaceutical's amivantamab-vmjw.
Adaptive Biotechnologies Gets IVDR Class C Certification for ClonoSeq Assay
The certification makes the ClonoSeq assay available to EU patients and enables Adaptive to process EU clinical trial samples in its US laboratory.
The agency also recently published a statement regarding pathways for tests cleared in the US, Canada, EU, and Australia to be more quickly placed on the UK market.
Aug 5, 2022