Regulatory Approval: Page 2

With pilot program, FDA seeks to reduce risks of LDTs that identify cancer biomarkers
By LabPulse.com staff writers
The agency said it has become increasingly concerned that some companion diagnostic tests made by laboratories that it has not authorized may not provide accurate and reliable test results.
June 20, 2023
Fda Button Social
Seegene obtains IVDR certification for 30 diagnostic assays
By LabPulse.com staff writers
The newly certified assays include eight for gastrointestinal infections, seven for women's diseases, five for respiratory diseases, four for tuberculosis, three for meningitis, two for human papillomavirus (HPV), and one for drug resistance.
June 1, 2023
Test Tube Liquid Sample Social
FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
By LabPulse.com staff writers
Paxlovid is the fourth drug — and first antiviral pill — approved by the FDA to treat COVID-19 in adults.
May 25, 2023
Fda Button Social
Beckman Coulter Diagnostics announces global launch of immunoassay analyzer
By LabPulse.com staff writers
The analyzer can run up to 215 tests per hour per square meter and, according to Beckman Coulter Diagnostics, beta users attest to a feature that redefines their workday with no daily maintenance requirements.
May 15, 2023
Dx I 9000 Analyzer Sample Rack Social
FDA grants de novo request enabling the marketing of QuidelOrtho SARS-CoV-2 antibody tests
By LabPulse.com staff writers
The tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 to aid in identifying patients who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.
May 10, 2023
Covid 19 Antibody Social
FDA approves first respiratory syncytial virus vaccine
By Leo O'Connor
Arexvy is the first respiratory syncytial virus (RSV) vaccine approved for use in the U.S. It is indicated for the prevention of lower respiratory tract disease caused by the virus in individuals 60 years of age and older.
May 3, 2023
Vial Vaccine Vial Tech Social
Tempus granted FDA premarket approval for colorectal cancer CDx
By LabPulse.com staff writers
The NGS test detects substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status.
May 1, 2023
Colon2 Social
Myriad Genetics, Intermountain Health get N.Y. certification enabling solid tumor testing in all U.S. states
By LabPulse.com staff writers
The Intermountain Precision Genomics Laboratory has received certification from the New York State Department of Health Clinical Laboratory Evaluation Program.
April 18, 2023
Tumor Necrosis Factor Social
Leica Biosystems granted FDA clearance for Class II mismatch repair panel
By LabPulse.com staff writers
The Bond MMR Antibody Panel is available for clinical use on its automated Bond-III and Bond-Max immunohistochemistry instruments.
April 3, 2023
Digital Pathology Cytology Social
AmoyDx PLC Panel gets Japanese approval as companion diagnostic for NSCLC
By LabPulse.com staff writers
The AmoyDx PLC Panel has been approved in Japan for the identification of activating alterations in seven driver genes, including RET, to be used in identifying patients whose NSCLC is likely to respond to treatment with selpercatinib.
March 27, 2023
Cancer Lung 3 D Black Social
FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis
By Leo O'Connor
Specifically, the warning states that reports of adverse events after use of the vaccine under emergency use authorization (EUA) suggest increased risks of myocarditis and pericarditis, particularly from zero through seven days following vaccination.
March 14, 2023
Fda Button Social
Becton Dickinson HPV assay FDA approved with BD SurePath, Hologic ThinPrep Pap tests
By LabPulse.com staff writers
The BD Onclarity HPV Assay individually tests for an extended set of HPV types, including HPV 31, which poses a higher risk for causing cervical precancer than HPV 18, Becton Dickinson said.
February 21, 2023
Hpv Infection Social
Previous Page
Page 2 of 5
Next Page