Meridian Bioscience’s Campylobacter test cleared
This article was originally published in The Gray Sheet
Executive Summary
Firm will launch its Premier Campy test for detection of Campylobacter infection this week after receiving FDA clearance on Feb. 4, according to a company spokesman. The test launched in Europe in December 2008. Campylobacter infections are the most commonly diagnosed bacteria for food-borne illness in the U.S., and are most often caused by poorly cooked poultry. Around 20 million screens for the bacteria are conducted in the U.S. each year. Meridian says its antigen measuring test is more accurate than the Campylobacter bacteria culturing process, which can be less sensitive due to variable culturing procedures, specimen viability and inhibitory antibiotics in culture media
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.