Citing significant concerns of bacterial contamination, the FDA urged consumers and health care providers to stop using specific lots of SD Biosensor Inc.’s Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics Systems Inc. The agency warned that direct contact with the contaminated liquid solution could pose safety issues as well as impair the test’s performance.
SD Biosensor Inc. and SJL Partners LLC plan to take Meridian Biosciences Inc. private in a $1.53 billion cash deal reached after four months of negotiation. Meridian shareholders will receive $34 per share, which represents a premium of 32% on the share price at market close on March 17, the day before SDB and SJL first presented an offer to buy the company. On July 7, the proposed price was a 16% premium based on the one-month average price per share of Meridian’s common stock.
SD Biosensor Inc. made a splash in its KOSPI board debut on July 16, raising a total ₩776.4 billion (US$679.26 million). The company will now use the funds to mass-produce and promote the company’s diagnostic machines for various indications, including COVID-19.
As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
