Immuone Ltd. raised £2 million (US$2.4 million) to fund expansion of its operations to meet growing demand for its 3D human lung model. The company is hoping that its model will replace animal testing which is not always accurate at predicting the impact of drugs on humans. The funding came from the MEIF Proof of Concept & Early Stage Fund, Mercia’s EIS funds and Pioneer Group.
Scientists at Washington University in St. Louis reported filing patent protection for their breath test that quickly identifies those infected with SARS-CoV-2, requires only one or two breaths to be performed, and provides results in less than a minute.
The U.S. FDA is keen on developing policies to guide testing regimes for future pandemics based on the experience with COVID-19, and the FDA’s Tim Stenzel said on a Sept. 8 advisory hearing that automated reporting of at-home tests would clarify questions such as the spread of the pathogen and how well the tests are performing. Stenzel, who is the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said the U.S. government agencies have made a number of grants for development of automated reporting mechanisms for at-home tests, signaling an interest on the FDA’s part that automated reporting capabilities will be a priority when the next pandemic strikes.
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.
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.
Oncologica Ltd. is expanding its testing service to include an at-home molecular immunoglobulin E (IgE) antibody allergy test. The Cambridge, U.K.-based precision medicine company said the new Allergyfocus test can detect 99% of globally known allergens from a finger prick blood sample. The IgE test provides a personalized antibody profile of allergy triggers such as different foods, pollen, mould or animals.
The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
LONDON – The U.K. has launched a nationwide free testing program to diagnose COVID-19 in people who are asymptomatic, in the latest attempt to stem the tide of infection. Through the program, all local authorities will provide rapid testing using lateral flow devices. In addition, companies will be provided with free tests to set up workplace screening. Initially, the focus of both strands will be on getting people who cannot work from home to come forward for regular checks.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.