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Meridian Bioscience announced the launch of its new Air-Dryable™ Direct DNA qPCR Saliva and Air-Dryable™ Direct RNA/DNA qPCR Saliva Mixes, enabling room-temperature stable molecular assays from saliva and sputum samples. These products address challenges in diagnostics due to PCR inhibitors in saliva, allowing for direct diagnosis without extensive sample processing. Dr. Lourdes Weltzien highlighted benefits such as reduced healthcare worker exposure and cost savings for manufacturers. Meridian aims to simplify diagnostic development and improve assay performance.
Meridian Bioscience (NASDAQ: VIVO) announced an expansion of the voluntary recall of its LeadCare Test Kits for lead detection in blood due to control test failures. The recall, initiated in May 2021, affects various lot numbers and underscores the risk of underestimating blood lead levels. The company recommends discontinuing the use of these kits and evaluating patient test results with alternative methods. The U.S. FDA has been notified of the situation, and product distribution has been paused until further notice.
Meridian Bioscience, Inc. (NASDAQ: VIVO) announced its participation in the H. C. Wainwright 23rd Annual Global Investment Conference. CEO Jack Kenny's pre-recorded presentation will be accessible starting September 13, 2021, at 7:00 am ET.
The presentation can be viewed for 90 days on the Company’s Investor Relations website. Meridian, a life science company, develops and distributes innovative diagnostic products, serving clients in over 70 countries. For details on the conference, visit the official website.
Meridian Bioscience reported Q3 2021 net revenues of $63.5 million, a 25% decline from Q3 2020 but a 31% increase from Q3 2019. The diagnostics segment grew 44% year-over-year to $31.2 million, while the life science segment decreased by 49% to $32.3 million. Operating income fell 55% to $15.7 million, though adjusted operating income was $12.9 million with a margin of 20%. The company reaffirmed its 2021 revenue guidance of $308 million to $314 million.
CINCINNATI, Aug. 2, 2021 - Meridian Bioscience announced the acquisition of the North American BreathTek® business from Otsuka America Pharmaceutical, effective July 31, 2021. This strategic move aims to enhance Meridian's diagnostic testing solutions and strengthen its market position. Financial impacts related to the acquisition will be discussed in the upcoming quarterly earnings call on August 6, 2021. Meridian is a global leader in diagnostic solutions, trading under the NASDAQ symbol VIVO.
Meridian Bioscience announced the acquisition of North America's BreathTek® business from Otsuka America Pharmaceutical for $20 million in cash, expected to close in the fiscal fourth quarter. This acquisition will provide Meridian with customer relationships for the urea breath test used to detect Helicobacter pylori, adding over $20 million to annual revenue. The CEO stated that this move leverages pandemic-generated cash to enhance Meridian's diagnostics segment, contributing to immediate earnings and cash growth.
Meridian Bioscience, Inc. (NASDAQ: VIVO) announced it will release its third quarter fiscal 2021 financial results on August 6, 2021. A conference call with CEO Jack Kenny and CFO Bryan Baldasare is scheduled at 10:00 a.m. ET to discuss the results. Participants can join the call by dialing the appropriate numbers based on their location. A replay of the call will be available for 14 days after the event. Meridian specializes in diagnostic testing solutions and life science raw materials, providing critical products across various sectors globally.
Meridian Bioscience (NASDAQ: VIVO) reported preliminary revenue of approximately $63.5 million for Q3 fiscal 2021, falling short of expectations. This decline was mainly attributed to supply chain issues with LeadCare reagents and reduced demand for COVID-19 testing reagents. The company has yet to finalize its financial statements and will provide detailed results and any fiscal guidance adjustments during its earnings call on August 6, 2021.
Meridian Bioscience has re-submitted its Emergency Use Authorization (EUA) application to the FDA for its SARS-CoV-2 molecular diagnostic test on the Revogene platform. This follows the voluntary withdrawal of their previous application on February 22, 2021, to conduct further studies as advised by the FDA. The new application was re-submitted on June 25, 2021. Executive Vice President Tony Serafini-Lamanna expressed optimism regarding the FDA's forthcoming review of the Revogene SARS-CoV-2 assay.
Meridian Bioscience announced the launch of its Lyo-Ready™ RT-LAMP Mix, aimed at enhancing RNA virus detection. This product facilitates development of assays that can be stored at ambient temperatures, eliminating the need for cold storage. The RT-LAMP technology simplifies point-of-care testing, reducing costs and complexity. The newly formulated mix offers superior amplification sensitivity and specificity, catering to various applications, including human diagnostics and environmental testing. With COVID-19 testing needs, this innovation positions Meridian to meet market demands effectively.