Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test. Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to […]
Meridian Bioscience Inc.
Magellan widens lead test recall
The FDA this week expanded its Class I recall of lead poisoning tests from Magellan Diagnostics to include 2 additional testing systems. The regulatory watchdog said it recalled Magellan’s LeadCare testing systems because they may underestimate blood lead levels and provide inaccurate results with venous blood samples. Get the full story at our sister site, Drug […]
pSivida, Alimera want FDA to give eye treatment another look | Regulatory roundup
Intel and GE win FDA clearance for virtual care platform | Regulatory roundup
Intel Corp. (NSDQ:INTC) and General Electric Co. (NYSE:GE) joint venture Intel-GE Care Innovations LLC won 510(k) clearance from the Food & Drug Administration for a virtual care coordination platform.
The clearance for the news system, called Intel Health Guide Express, brings the companies another step closer to making the product available for off-the-shelf personal computers.
Sans swine flu, Meridian earnings sink 32 percent
Swine flu fears pushed up demand for Meridian Bioscience Inc.’s (NSDQ:VIVO) rapid flu tests a year ago, but the absence of those concerns contributed to a 32 percent decline in the diagnostic test maker’s first-quarter earnings for fiscal 2011.
It marked the fourth consecutive quarter of declining year-over-year earnings for the West Chester, Ohio, company. The company reported net earnings of $6 million or 16 cents per diluted share.
That fell below analysts’ expectations of 19 cents per diluted share.
Meridian Bioscience has a squatter — on Twitter
It happened to diagnostic test maker Meridian Bioscience Inc. (NSDQ:VIVO), but at least it doesn’t appear to have caused any damage.
Meridian was victimized by a Twitter “name squatter.” That is, someone not affiliated with the company created a Twitter account using its name, logo and references to its website.
Meridian Bioscience dives on “disappointing” Q4 results
Diagnostics maker Meridian Bioscience Inc. (NSDQ:VIVO) capped a “disappointing” fiscal 2010 with fourth-quarter profits that fell below Wall Street’s expectations and sent its shares tumbling.
Fourth-quarter profits fell 40 percent to $5.3 million, or 13 cents per diluted share. Excluding special items associated with the costs of an acquisition, per-share earnings came in at 15 cents, according to a statement from the Cincinnati-based company.
Meridian Bioscience wins Canadian OK for C. difficile test
Meridian Bioscience Inc. (NSDQ:VIVO) obtained a license to begin selling its illumigene C. difficile molecular test in Canada.
C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Meridian’s illumigene C. difficile test can detect the presence of the bacteria in a sample and deliver results within an hour, according to Cincinnati-based company.
Meridian Bioscience optimistic about about FY 2011
As it rounds out a “very difficult” fiscal 2010, diagnostic test maker Meridian Bioscience Inc. (NSDQ:VIVO) sees better things in 2011.
The Cincinnati, Ohio-based company released optimistic guidance for the upcoming fiscal year. It expects earnings between 77 cents and 82 cents per diluted share, and sales between $165 million and $170 million, according to the company.
Investors liked the sound of those numbers and pushed the company’s stock up about 3.7 percent to $18.86 by late Monday afternoon.
Despite poor earnings, Meridian Bioscience touts purchase of British firm
By Mary Vanac
Meridian Bioscience Inc. (NSDQ:VIVO) acquired the outstanding capital stock of Bioline Ltd., the London, U.K.-based maker and distributor of molecular biology reagents, for $23.3 million in cash.
The company also said Tuesday its profits fell 24 percent in its third quarter from a year ago, because of continuing weakness in respiratory disease test sales caused by a lack of a flu season and competition for sales of C. difficile tests.
Meridian Bioscience lands FDA clearance for C. difficile test
By Mary Vanacc
Diagnostics company Meridian Bioscience Inc. (NSDQ:VIVO) received the go-ahead from the Food & Drug Administration to sell its first molecular test — illumigene C. difficile.
The Cincinnati life science company has has success making diagnostic test kits that detect pathogens like C. difficile which is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.
