On November 18, 2020, the U.S. Food and Drug Administration (FDA) authorized the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home. The FDA issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results.
The Lucira™ COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers. “There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious,” said Lucira Health CEO Erik Engelson. “Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected… Continue reading.
WASHINGTON, D.C.—The American Institute for Medical and Biological Engineering (AIMBE) has announced the induction of Erik Engelson, MS, MBA, Managing Partner, Epic Pacific, LLC, to its College of Fellows.
Election to the AIMBE College of Fellows is among the highest professional distinctions accorded to a medical and biological engineer. The College of Fellows is comprised of the top two percent of medical and biological engineers. College membership honors those who have made outstanding contributions to “engineering and medicine research, practice, or education” and to “the pioneering of new and developing fields of technology, making major advancements in traditional fields of medical and biological engineering, or developing/implementing innovative approaches to bioengineering education.”
Mr. Engelson was nominated, reviewed, and elected by peers and members of the College of Fellows for “executive corporate leadership and engineering design of multiple medical devices, including the variable stiffness catheter, which transformed interventional neuroradiology.”