FDA submission
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.
Guardant Health CRC Screening Results Spook Investors Despite Meeting Reimbursement Requirements
The company said it hasn't changed its plans to submit its Shield test to the FDA, but the lower-than-expected performance data led to a significant drop in Guardant's share price.
Cue Health Files for Full FDA Clearance of COVID-19 Molecular Test
The test received Emergency Use Authorization from the FDA in March 2021 and would be only the second COVID-19 test to receive FDA clearance.
Enzo Biochem Q1 2022 Revenues Down 8 Percent
The company said its life sciences revenues fell 9 percent from Q1 2021 because of ongoing COVID-19-related shutdowns in Europe, among other reasons.
Geneoscopy Closes $105M Series B Financing Round
The company said it will use the funds in part to support a study of ColonoSight, its multi-target stool RNA test for colorectal screening.