Testing lab launched

MASON – Mobility Health, a biohealth start-up located at 5155 Financial Way, one of three Mason Tech Eleva- tor campuses, launched its mobile infectious disease testing laboratory, offering businesses and organi- zations a highly-accurate, rapid COVID-19 test to protect employees and customers. On Jan. 4, Mobility Health’s mobile lab performed testing at a Mason-based manufacturing company on three shifts of employees as they returned from the holiday break. Overall, more than 250 employees were tested with results delivered the same day.

Sandra Gunselman, Ph.D., who founded Mobility Health and serves as president and CEO, was the vice president of lab operations for Assurex Health, a successful Mason biohealth start-up in phar- macogenetics, that eventually was purchased by Myriad Genetics.

“The idea for Mobility Health really came to me as I was watching the news back in January about the pandemic,” said Gunselman. “Testing was inaccurate, but it was all we had. As I talked with colleagues around the world, I just knew it could be done better and was imperative to stop the spread. Find- ing the best rapid technol- ogy out there, validating it, and making it available in a mobile lab seemed like the ideal solution.”

Mobility Health is the first company to market with a loop-mediated isother- mal amplification (LAMP) test for SARS-CoV-2 – which causes COVID-19 – which is more accurate and faster than other tests, according to Gunselman. “We went through a rigorous validation process based on CDC and CMS guidelines to confirm the accuracy of this rapid test before taking it to market,” she said. “Not only were we able to show higher accuracy (100% specificity – no false negatives) and (99% sensitivity – fewer false positives) than other tests on the market, but we showed strong reproducibility and robustness, meaning we can replicate the test across different equipment and technicians with the same results. The test is a mid-turbinate nasal swab with results available in about 2 hours.”

Gunselman noted that the LAMP test was designed anticipating there would be variants of the COVID19 virus, as recently discovered. As a result, the test is not affected by the virus variants and still performs at the same level of accuracy and precision. In contrast, the typical polymerase chain reaction (PCR) test on the market ranges from 24 hours to several days for results and has a 90-97% sensitivity rate and 98% specificity.

Next year, Mobility Health will have the ability to test individuals attending events and send results to cell phones via QR code that can be scanned to confirm a negative result before entering. Mobility Health is developing a full panel of infectious diseases, including influenza A, B, rhinovirus, respiratory syncytial virus, parainfluenza, and others.