FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device
By Sam Brusco, Associate Editor | 03.23.21
Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.
The U.S. Food and Drug Administration issued emergency use authorization (EUA) for the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).
The Tiger Tech COVID Plus Monitor helps prevent SARS-CoV-2 exposure and spread. It identifies certain biomarkers that may be indicative of infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in asymptomatic individuals over the age of 5. The Tiger Tech COVID Plus Monitor is designed for use following a temperature reading that doesn’t meet criteria for fever in settings where temperature check is being conducted in accordance with CDC and local institutional infection prevention and control guidelines. It isn’t a substitute for a COVID-19 diagnostic test, and is not intended for use in those with COVID-19 symptoms.
“The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools,” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health told the press. “Combining use of this new screening device, that can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums and airports.”
The device is an armband with embedded light sensors and a small computer processor. The armband is wrapped around a person’s bare left arm above the elbow. The sensors first obtain pulsatile signals from blood flow over three to five minutes. Once the measurement is completed, the processor extracts key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation in blood. Hypercoagulation is known to be a common abnormality in COVID-19 patients. The result is provided in the form of different colored lights used to indicate if an individual is demonstrating certain biomarkers, or if the result is inconclusive.
Clinical performance was studied in hospital and school settings. The hospital study, which was considered a validation study, enrolled 467 asymptomatic individuals, including 69 confirmed positive cases, and demonstrated the Tiger Tech COVID Plus Monitor had a positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6 percent and a negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5 percent. The school study, considered a confirmatory study, showed similar performance.
The Tiger Tech COVID Plus Monitor is not a diagnostic device and must not be used to diagnose or exclude SARS-CoV-2 infection. The device is intended for use on individuals without a fever. An individual’s underlying condition may interfere with the COVID-19 related performance of the device and could lead to an incorrect screening result.
The Tiger Tech COVID Plus Monitor helps prevent SARS-CoV-2 exposure and spread. It identifies certain biomarkers that may be indicative of infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in asymptomatic individuals over the age of 5. The Tiger Tech COVID Plus Monitor is designed for use following a temperature reading that doesn’t meet criteria for fever in settings where temperature check is being conducted in accordance with CDC and local institutional infection prevention and control guidelines. It isn’t a substitute for a COVID-19 diagnostic test, and is not intended for use in those with COVID-19 symptoms.
“The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools,” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health told the press. “Combining use of this new screening device, that can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums and airports.”
The device is an armband with embedded light sensors and a small computer processor. The armband is wrapped around a person’s bare left arm above the elbow. The sensors first obtain pulsatile signals from blood flow over three to five minutes. Once the measurement is completed, the processor extracts key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation in blood. Hypercoagulation is known to be a common abnormality in COVID-19 patients. The result is provided in the form of different colored lights used to indicate if an individual is demonstrating certain biomarkers, or if the result is inconclusive.
Clinical performance was studied in hospital and school settings. The hospital study, which was considered a validation study, enrolled 467 asymptomatic individuals, including 69 confirmed positive cases, and demonstrated the Tiger Tech COVID Plus Monitor had a positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6 percent and a negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5 percent. The school study, considered a confirmatory study, showed similar performance.
The Tiger Tech COVID Plus Monitor is not a diagnostic device and must not be used to diagnose or exclude SARS-CoV-2 infection. The device is intended for use on individuals without a fever. An individual’s underlying condition may interfere with the COVID-19 related performance of the device and could lead to an incorrect screening result.
