FDA submission
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.
GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test
The test recently received a CPT PLA code and is currently offered through GenInCode's laboratory in Irvine, California.
Guardant Health Pushing Hard to Contextualize CRC Screening Data as Core Business Chugs Along
Premium
The company is seeing continuing growth for its existing clinical products as it moves resources toward commercialization of its Guardant Shield CRC screening test.
Cue Health Submits At-Home Molecular RSV Assay to FDA
The de novo submission is for a molecular diagnostic test for respiratory syncytial virus meant for home and point-of-care use.
Dec 15, 2021
Enzo Biochem Q1 2022 Revenues Down 8 Percent
Nov 16, 2021
Geneoscopy Closes $105M Series B Financing Round
Nov 11, 2020
Sep 25, 2020