FDA clearance
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.
Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test
The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
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
FDA Clears NantHealth Tumor-Normal Whole-Exome Test
Oct 1, 2019