Policy and Regulation: Page 4

KSQ Therapeutics receives FDA clearance for trial of CRISPR-Cas9 engineered tumor therapy
By LabPulse.com staff writers
Biotech firm KSQ Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a phase I and II trial of KSQ-001EX, KSQ’s CRISPR-Cas9 engineered tumor-infiltrating lymphocyte program.
November 29, 2023
Crispr Cas9 Gene Editing Social
AMP, other stakeholders urge Congress to pause FDA LDT rule, update CLIA
By LabPulse.com staff writers
The Association for Molecular Pathology (AMP) requested Congress to update the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to the FDA’s proposed rule to increase agency oversight of laboratory-developed tests (LDTs).
November 22, 2023
Washington Dc Capitol Social
U.K. regulators approve 'world-first' sickle-cell gene therapy
By Matt Limb
U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease and transfusion-dependent ÎČ-thalassemia. They are the first regulatory body to approve the treatment.
November 20, 2023
Sickle Cell Anemia2 Social
FDA plans to increase oversight of LDTs garner strong response
By Nick Paul Taylor
Plans to increase U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs) have drawn a strong response from trade groups, individuals, and organizations.
November 17, 2023
Fda Sign Dc Social
Zymo Research, Ad Astra Diagnostics receive FDA 510(k) clearances
By LabPulse.com staff writers
Molecular diagnostics firm Zymo Research and rapid diagnostics developer Ad Astra Diagnostics have both received 510(k) clearances from the U.S. Food and Drug Administration.
November 16, 2023
Fda Button Social
FDA grants approval to Takeda’s metastatic colorectal cancer therapy
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a chemotherapy-free oral target therapy for patients who have been previously treated for metastatic colorectal cancer (mCRC).
November 9, 2023
Fda Button Social
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
BioMĂ©rieux receives CE Mark for biomarker assay for mild TBI
By LabPulse.com staff writers
BioMĂ©rieux 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
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