Policy and Regulation: Page 5

Vertex Pharmaceuticals, CRISPR Therapeutics gene-editing therapy to undergo FDA advisory committee review
By LabPulse.com staff writers
An FDA advisory committee is scheduled to meet on October 31 to discuss and make recommendations on Vertex Pharmaceuticals' and CRISPR Therapeutics’ CRISPR-Cas9 gene-editing-based therapy, exagamglogene autotemcel.
October 30, 2023
Fda Sign Dc Social
FDA to discuss phaseout enforcement discretion for LDTs
By Liz Carey
In relation to its proposed medical device rule targeting laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) will hold a webinar Tuesday, October 31, at 1 p.m. EST.
October 26, 2023
Lab Vacutainer Test Tube Social
3EO Health to launch FDA-approved COVID-19 test
By Matt Limb
Molecular diagnostics startup 3EO Health is preparing to launch a newly approved SARS-CoV-2 test with its portable molecular device, saying it will “expand access” to the technology.
October 20, 2023
Coronavirus Hologram Blue Social
BioMérieux receives CE Mark for biomarker assay for mild TBI
By LabPulse.com staff writers
BioMérieux has obtained the CE Mark for its assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).
October 16, 2023
Football Player Concussion Social
European Commission orders Illumina to sell Grail
By LabPulse.com staff writers
Illumina has been ordered by the European Commission to sell Grail following the European Union antitrust regulatory body’s determination to prohibit the $8 billion acquisition of the company.
October 12, 2023
Eu Flag European Commission Brussels Social
ACLA warns proposed Medicare criteria will ‘impede’ access to genetic oncology testing
By Nick Paul Taylor
The American Clinical Laboratory Association (ACLA) has warned that draft Medicare coverage criteria “will impede patient access to appropriate genetic testing for oncology.”
October 6, 2023
Lab Test Tube Dna Blood Social
FDA authorizes Invitae hereditary cancer panel
By Nick Paul Taylor
The U.S. Food and Drug Administration (FDA) has granted de novo authorization to an Invitae panel that tests for hundreds of genetic variants that indicate whether a person has a higher risk of developing certain cancers.
October 5, 2023
Dna Cancer Cell Social
ProciseDx receives FDA de novo authorization for therapeutic drug monitoring tests
By LabPulse.com staff writers
ProciseDx has received U.S. Food and Drug Administrtion (FDA) de novo marketing authorization for its point-of-care tests for monitoring levels of infliximab and adalimumab in patients being treated for inflammatory bowel diseases.
October 5, 2023
Fda Button Social
FDA issues EUAs for 2 POC COVID-19 tests
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) granted emergency use authorizations (EUAs) for two separate point-of-care (POC) assays for SARS-CoV-2 developed by Tangen Biosciences and SD Biosensor.
October 4, 2023
3d Closeup Coronavirus Social
Thermo Fisher receives FDA clearance for neuroendocrine tumor assay
By LabPulse.com staff writers
Thermo Fisher has received clearance from the U.S. Food and Drug Administration (FDA) for its Brahms chromogranin A (CgA) II Kryptor test, a CgA immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor patients.
October 2, 2023
Fda Sign Dc Social
Labs and manufacturers face challenges with rollout of IVDR
By Matt Limb
Laboratories and medical device manufacturers have revealed how they face technical and workload challenges in gearing up to comply with stringent new European Union regulations.
October 2, 2023
Regulation Wheel Social
Alzheimer’s drug approval poised to reshape APOE testing market
By Nick Paul Taylor
The U.S. Food and Drug Administration (FDA) approval of Biogen and Eisai’s Alzheimer’s disease drug Leqembi is likely to drive changes in the APOE testing market, according to an article in GenomeWeb.
September 25, 2023
Amyloid Plaque Alzheimer Social
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