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.
FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen
The approval makes Lumakras the first inhibitor of KRAS, once considered "undruggable," to reach the market for KRAS-mutated NSCLC.
FDA Grants EUA to Enzo Biochem Sample Collection Kit for COVID-19 Testing
The company said its Ampicollect kit is now available for sample collection as part of COVID-19 testing protocols in the US.
Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit
This modular system uses a high-throughput version of the company's Applied Biosystems TaqPath COVID-19 Combo Kit, which received an EUA in March 2020.
Sep 8, 2020
FDA Clears DiaSorin Test for Influenza, RSV
Sep 8, 2020
Roche BK Virus Test Garners FDA Clearance
May 13, 2020
Dec 17, 2019
FDA Clears DiaSorin Molecular VZV Test
Nov 12, 2019