The epic rise and fall of Elizabeth Holmes, founder of Theranos Inc., will preoccupy the world of business for decades to come, but this story has also left a large footprint in the world of clinical diagnostics. David Stein, CEO of Babson Diagnostics Inc., of Austin, Texas, told BioWorld that investors are a bit more wary than usual because of the Theranos saga, forcing test developers to be more rigorous in test development and more transparent with investors about a test.

The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications.

Over the course of the past two years, two presidential administrations and the U.S. Congress have set considerable sums of money aside for testing for the COVID-19 pandemic, but reports of shortages of tests have prompted a response from Capitol Hill.

Researchers at the University of Pennsylvania’s Perelman School of Medicine have shown how nanoparticles could be used to reduce neutrophil clumping in inflamed lungs – making them a pathway for diagnosis and treatment of acute lung inflammation (ALI) and acute respiratory distress syndrome (ARDS).

In the season of college bowl games, two long-time rivals are vying for another title, the right to claim being the first to install Siemens Healthineers AG’s Magnetom Free.Max magnetic resonance imaging (MRI) system. Both the Ohio State University and the University of Michigan said they were first in the U.S. to put in the recently approved system.

Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier.

Genetic testing for health care purposes took a hit with the onset of the COVID-19 pandemic, but there are concerns about the volume of these tests in the four years before the onset of the pandemic. The U.S. Office of Inspector General (OIG) said recently that the data suggest possible fraud and abuse of the Medicare program, and that the picture suggests a need for a more concerted regulatory effort by the CMS.

The run on at-home COVID-19 tests may be for naught. The FDA warned that the popular rapid antigen tests recommended to keep New Year’s Eve revelers, relatives visiting elderly grandparents and workers exposed to the coronavirus from spreading COVID-19 are less likely to detect the Omicron variant than earlier strains of the virus. “Early data suggest that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said in an update on Dec. 29. Despite the higher rate of false negatives, the FDA said individuals should continue to use the tests. Those experiencing symptoms or with a high likelihood of infection based on exposure should follow-up with a molecular test if their antigen test returns a negative result.

The Verifying Accurate Leading-edge IVCT Development (VALID) Act seems poised for passage in 2022, a bit of welcome relief for those stuck in the regulatory twilight world of the lab-developed test (LDT). However, Carly McWilliams, director of regulatory policy for North America for Roche Inc., said recently at the recent Food and Drug Law Institute enforcement meeting that the VALID Act is likely to leave the question of a user fee schedule for a future Congress, given that the associated rulemaking, guidance development and compliance activities are likely to consume the better part of, if not the entirety of, the next five years.