FDA submission
Fujirebio Files Blood-Based Alzheimer's Test With FDA
The test measures levels of p-tau 217 and β-Amyloid 1-42 in human plasma to identify patients with the amyloid brain pathology characteristic of Alzheimer's disease.
Nuclein Submits Combo COVID, Flu Point-of-Care RT-qPCR Test for FDA 510(k) Clearance, CLIA Waiver
The cartridge-based test detects SARS-CoV-2, influenza A, and influenza B in approximately 15 minutes.
QuidelOrtho Withdraws Submitted Savanna Respiratory Panel, Obtains FDA Clearance for COVID-19 Test
The firm said the final performance data for the Savanna RVP4+ panel did not meet its expectations, and it will now resubmit a next-gen version.
CorDx Submits Flu, COVID-19 Rapid Test to FDA for EUA
The multiplex lateral flow test delivers results in 10 minutes from nasal swab samples and is intended for both point-of-care and over-the-counter use.
Top Five Articles on 360Dx Last Week: Opposition to FDA LDT Proposal; Natera, Invitae Deal, More
Last week, readers were most interested in a story about public comments made by labs and health providers opposing the FDA's plan to regulate LDTs.
Dec 15, 2021
Enzo Biochem Q1 2022 Revenues Down 8 Percent
Nov 16, 2021