FDA submission
Guardant Health Pushing Hard to Contextualize CRC Screening Data as Core Business Chugs Along
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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.
OpGen Seeking FDA Marketing Authorization for Urinary Tract Infection Panel
The FDA submission follows completion of a clinical trial showing the highly multiplexed PCR assay had 96.8 percent sensitivity and 97.4 percent specificity.
Guardant Health Submits Colorectal Cancer Screening Test to FDA for Premarket Approval
The firm's application is supported by data from the ECLIPSE study, which compared results of the Shield test to colonoscopy findings in 20,000 individuals.
Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test
The application is supported by data from the company's prospective trial, demonstrating 94 percent sensitivity for CRC in an average-risk cohort.