FDA clearance

FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug

The Oncomine Dx Target Test can now be used to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for ivosidenib.

Invitae Writes off $262.5M Liability Upon Failure to Meet Regulatory Milestone

The company still expects the Stratafide cancer test to achieve FDA approval or clearance, but after March 31, 2022.

Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Others Nab FDA Clearances in July

Siemens Healthineers obtained clearances for four tests, including its N Latex FLC kappa and lambda reagents to diagnose multiple myeloma and other medical conditions.

First Light Diagnostics C. Difficile Test Nabs FDA Clearance

The test runs on the firm's MultiPath Analyzer for single molecule counting to detect C. difficile toxins A and B.

FDA Clears Sysmex Hematology Analyzer With Blood Bank Mode

The firm said that its XN Blood Bank mode provides accurate cell counts on products that are important to blood centers and blood banks.

May 28, 2021

FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen

May 10, 2021

Immunodiagnostic Systems, Retractable Technologies, Immunalysis Receive FDA 510(k) Clearances in April

Apr 21, 2021

FDA Grants EUA to Enzo Biochem Sample Collection Kit for COVID-19 Testing

Apr 13, 2021

Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit

Apr 2, 2021

Gold Standard Diagnostics Nabs FDA Clearance for Lyme Disease Test

Mar 9, 2021

DiaSorin, Roche, Inova Diagnostics Receive FDA 510(k) Clearances in February

Feb 8, 2021

Siemens Healthineers, Roche, Abbott Receive FDA 510(k) Clearances in January

Jan 11, 2021

Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test

Dec 15, 2020

Horiba Medical Receives FDA, Health Canada Clearances for High-Throughput Clinical Chemistry Analyzer

Dec 9, 2020

Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test

Nov 11, 2020

DiaSorin, CellaVision, Scopio Labs, Others Receive FDA 510(k) Clearances in October

Oct 7, 2020

BioMérieux, Roche, Becton Dickinson, Others Receive FDA 510(k) Clearances in September

Oct 2, 2020

Chembio Diagnostics HIV-Syphilis Testing System Receives FDA Approval

Sep 29, 2020

Oxford Immunotec Gets FDA Clearance for TB Test in Patients Aged Two and Older

Sep 16, 2020

FDA Clears Enhancements to Accelerate Diagnostics Pheno System

Sep 9, 2020

Ancestry, 23andMe, DiaSorin, Adaptive Biotechnologies, Others Receive FDA Clearances in August

Sep 8, 2020

FDA Clears DiaSorin Test for Influenza, RSV