Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection

Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a temperature reading that does not meet criteria for fever

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U.S. Food and Drug Administration

Mar 19, 2021, 18:25 ET

SILVER SPRING, Md., March 19, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are 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 is intended for use by trained personnel to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19. The device identifies certain biomarkers that may be indicative of SARS-CoV-2 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 does not meet criteria for fever in settings where temperature check is being conducted in accordance with Centers for Disease Control and Prevention (CDC) and local institutional infection prevention and control guidelines. This device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19.

"The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools," said Jeff Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "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 during use. The sensors first obtain pulsatile signals from blood flow over a period of three to five minutes. Once the measurement is completed, the processor extracts some key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model that has been 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.

The clinical performance of the Tiger Tech COVID Plus Monitor 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 that 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% 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%. The school study, which was 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 FDA issued the EUA to Tiger Tech Solutions, Inc.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration