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Meridian Bioscience, Inc. (NASDAQ: VIVO) announced the retirement of David Phillips as Chairman of the Board, effective January 2022. Phillips, who joined the board in 2000 and became chairman in 2018, is credited with steering the company through major developments, including Sarbanes-Oxley implementation and numerous acquisitions. Under his leadership, Meridian's employee base and financial performance significantly improved, with fiscal 2021 revenues and earnings per share over five times those of 2000. The board will elect a new chair post-retirement, reducing the board size to eight.
On November 17, 2021, Meridian Bioscience (NASDAQ: VIVO) announced the launch of its innovative Air-Dryable™ LAMP Mix and Air-Dryable™ RT-LAMP 1-Step Mix. These molecular master mixes enable rapid isothermal amplification of nucleic acid sequences, slashing the typical 45-minute result time in half. Designed to facilitate point-of-care testing, the mixes support increased sample sizes and include a pre-optimized buffer system for improved sensitivity and specificity. The developments aim to expedite assay optimization and reduce manufacturing costs, enhancing the overall diagnostic capabilities for test manufacturers.
Meridian Bioscience (NASDAQ: VIVO) reported Q4 and FY2021 financial results with consolidated net revenues of $76.2 million, up 19% year-over-year. For FY2021, revenues rose 25% to $317.9 million, driven by a 43% increase in the Life Science segment and $111.9 million from COVID-19 products. Operating income for Q4 was $8.5 million (11% margin), and FY2021 was $93 million (29% margin). The company faces challenges from product recalls and upcoming FDA approvals. Guidance for FY2022 estimates revenues between $285-$300 million with an adjusted operating margin of 21%-22%.
Meridian Bioscience, Inc. (NASDAQ: VIVO) announced that the Revogene® SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the FDA. Shipments are expected to begin before December 31, 2021. This molecular diagnostic test provides results in as little as 47 minutes, boasting a positive predictive agreement (PPA) and negative predictive agreement (NPA) of 97.7%. The assay aims to enhance COVID-19 testing capacity for healthcare systems, addressing the ongoing demand for accurate detection amid emerging variants.
Meridian Bioscience (NASDAQ: VIVO) announced the launch of two innovative Air-Dryable™ qPCR Mixes, enhancing direct detection of DNA or RNA from urine samples. These mixes address the inhibition challenges associated with crude urine samples, allowing for faster and more sensitive molecular assays without the need for tedious purification. This innovative technology simplifies assay setup, making it cost-effective and suitable for point-of-care applications. Meridian's commitment to innovation positions it to deliver superior diagnostic solutions, improving patient compliance and satisfaction.
Meridian Bioscience (NASDAQ: VIVO) will announce its fourth quarter and full year 2021 financial results on November 12, 2021. The event will feature a conference call at 10:00 a.m. Eastern Time led by CEO Jack Kenny and CFO Bryan Baldasare. A live webcast will be available for investors, alongside a telephone option for participants. Additionally, a recorded version will be accessible for one year post-event. Meridian specializes in diagnostic products across various sectors, providing essential solutions globally.
Meridian Bioscience (NASDAQ: VIVO) launched its new Air-Dryable™ Direct RNA/DNA qPCR Blood Mix, designed for rapid and sensitive detection of viral and bacterial infections directly from blood samples. This innovative product simplifies the development of molecular diagnostics by eliminating the need for costly DNA/RNA purification. Compatible with air-drying, it replaces traditional lyophilization methods, reducing manufacturing costs and enhancing workflow efficiency. The technology supports applications in cancer management and forensic analyses, emphasizing Meridian's commitment to accelerating diagnostic solutions.
Meridian Bioscience recently launched two innovative Air-Dryable™ Master Mixes: the Air-Dryable™ Direct DNA qPCR Stool and Air-Dryable™ Direct RNA/DNA qPCR Stool Mixes. These products facilitate room-temperature stable molecular diagnostics from crude stool samples, eliminating the need for complex purification steps. This technology enhances assay speed and sensitivity, making it valuable for applications like gastrointestinal disease diagnosis. Meridian aims to simplify the development of diagnostic assays and is committed to accelerating solutions in the diagnostic industry. Shares are traded on NASDAQ under the symbol VIVO.
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.