Author Archives: Michelle Beaver

Geneoscopy Starts Clinical Trial for Home Colorectal-Cancer Test

ST. LOUIS, Missouri—Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced the enrollment of its first patients in the CRC-PREVENT pivotal trial. The clinical study seeks to evaluate the safety and efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a ...

Read More »

Companies Enter Partnership for Blood Test to Detect Colorectal Cancer and Pre-Cancer

SUNNYVALE, Calif., and ROSWELL, Ga.—CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, recently announced the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing. The financing will be used to accelerate the clinical development of CellMax’s multimodal ...

Read More »

FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

This week the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes—devices used to view and access the urinary tract. Reprocessing these types of medical devices involves both cleaning and high-level disinfection or sterilization so the devices ...

Read More »

Johns Hopkins Hosts Conference to Cover Advances in Endoscopy, Gastroenterology and Hepatology

Johns Hopkins Medicine will be hosting a conference to cover advances in endoscopy, gastroenterology and hepatology Saturday, March 13. This one-day activity will provide an update on a wide range of topics of interest to the those in the endoscopy profession. Rapid advances are being made in the understanding of the pathophysiology, natural history and treatment of diseases of the ...

Read More »

Sebela Pharmaceuticals Receives FDA Approval for SUTAB® Tablets for Colonoscopy Preparation

BRAINTREE, Mass. — Sebela Pharmaceuticals® this week announced that the U.S. Food and Drug Administration (FDA) approved SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. SUTAB, a sulfate-based tablet preparation for colonoscopy, was developed and will be marketed by Braintree Laboratories, the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution—the market leader in branded colonoscopy ...

Read More »