RESEARCH TRIANGLE PARK – BioMedomics, a medical diagnostic company based in RTP, says it has developed a novel coronavirus test that can turn around results in less than 15 minutes, potentially offering a fix to the current testing backlog.
The firm’s CEO Dr. Frank Wang said it is one of the world’s first rapid screening tests for the virus developed by its Chinese subsidiary, Medomics Medical Technology, and is already being used in China, South Korea, Japan, Italy and some Middle East countries.
However, the test does not currently have approval from the U.S Food and Drug Administration (FDA).
Wang said the firm is looking at possible options to get over regulatory hurdles so that the test can be widely administered in the United States.
“We are in contact with the Centers for Disease Control and Prevention, and have approached the FDA to inquire about U.S. market,” he told WRAL TechWire.
The coronavirus outbreak continues to ramp up – with more than 150 cases and 11 deaths in 13 states as of Wednesday.
The Trump administration is dealing with complaints from health providers and state and local authorities that they lack sufficient testing capacity to check the virus’s spread.
Wang said the current standard diagnostic method for diagnosis of COVID-19, RT-PCR test, has several limitations.
These tests have long turnaround times and are complicated in operation; they generally take on average over two to three hours to generate results.
They also require certified laboratories, expensive equipment and trained technicians to operate, and have a high number of false negatives.
“These limitations make RT-PCR unsuitable for use in the field for rapid and simple diagnosis and screening of patients,” the firm said in a paper published in the Journal of Virology. “It limits the outbreak containment effort”
Conversely, BioMedomics is a blood test that is “rapid, simple to use, sensitive, and accurate.”
“Because there is no medicine or vaccine, the best way to combat this infection is isolation. A lot of people don’t have symptoms. Because of that, quick diagnostics are very important,” Wang said. “You can identify infection and isolate people.”