December 12, 2022, Intelligence: Late-Breaking Lab News

Is it time to allow consumers to do at-home testing for influenza? Given the already-raging influenza season—flu-related hospitalizations doubled the week of Nov. 20 compared to a week earlier, according to the Centers for Disease Control and Prevention—the STAT medical news site raised an interesting question about why at-home flu tests were not available. That may be a surprising fact given how many consumers continue to self-check possible COVID-19 symptoms with rapid tests. Yet historically, physicians and the U.S. Food and Drug Administration (FDA) have shied away from supporting at-home flu testing.

MORE ON: Flu Tests

“It is really rare, and it is really new, that people are allowed to know about what’s happening inside their body without a physician in the middle,” Michael Mina, MD, Chief Science Officer at eMed, told STAT. The Miami company sells virtually-proctored at-home COVID-19 tests. One concern is that some prototype rapid flu tests proved to be reliable only 11% of the time in accurately detecting the illness, STAT reported. Because prominent influenza strains change year to year, the FDA also has worries about people using a prior year’s at-home test. However, there are rapid flu tests used at emergency rooms and retail pharmacies that are waived under the Clinical Laboratory Improvement Amendments, according to a July 2019 report in the Journal of Clinical Virology. Bringing telemedicine into the picture so that a physician or nurse can virtually observe a patient swab for the flu, might assuage regulator concerns, Mina suggested.


Sanford Health in Sioux Falls, S.D., now offers free genetic testing to current U.S. military personnel and veterans who receive their primary care from the health system, according to Valley News Live. The Dark Report previously noted that Sanford began offering a genetic test panel to patients in July 2018. It remains uncommon for healthcare systems to offer a pharmacogenetics test in primary care settings, so Sanford continues to pioneer this area of genetic diagnostics and clinical laboratory medicine. 


Brad Moore has been named President and CEO of Roche Diagnostics North America effective Jan. 1. He is currently Senior Vice President of Core Lab and Point of Care at Roche Diagnostics North America. He previously worked at Johnson and Johnson and LifeScan Canada. 

Precision cancer diagnostics firm Epredia in Kalamazoo, Mich., has promoted Dave Sanford to Senior Director of Global Product Marketing. He has been at Epredia since 2019. Previously, he worked in marketing roles at Thermo Fisher Scientific.



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