COVID PLUS Monitor

Tiger Tech Solutions, Inc.

INDICATION FOR USE: Non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation.

ADDRESSING UNMET NEED: First Machine Learning-Based screening device to identify certain biomarkers that may indicate COVID-19 infection. Combining use of this new screening device with temperature checks could help identify asymptomatic individuals.

DESCRIPTION:

• Arm-band with two embedded photoplethysmography (PPG) sensors and a processor that is wrapped around the recipient’s bare left arm above the elbow
• PPG sensors acquire direct pulsatile biosignals over 3-5 minutes; processor interprets signals
• Fed into a probabilistic machine learning model trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation
• Green light (not demonstrating biomarkers), red light (demonstrating biomarkers), blue light (test is inconclusive) due to indeterminate features

CLINICAL PERFORMANCE:

• Validation study : Hospital study (n=467 asymptomatic individuals)
• Positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6%
• Negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5%
• Confirmatory study: School study, with similar performance

REGULATORY PATHWAY: Emergency Use Authorization

EUA Authorization Letter

BioFire Respiratory Panel

Biofire Diagnostics

INDICATION FOR USE: PCR-based multiplexed nucleic acid test intended for use with the BioFire FilmArray 2.0 or BioFire FilmArray Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19.

ADDRESSING UNMET NEED: Multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab.

DEVICE TYPE: Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

Is for use only for people suspected of respiratory tract infections, including COVID-19. 

Should be used by health care providers in combination with a clinical examination and consideration of patient medical history.

REGULATORY PATHWAY: First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review – De Novo pathway

• Regulation Number: 21 CFR 866.3981
• Regulatory Class: Class II
• Product Code: QOF

CLASSIFICATION ORDER

Screening vs Diagnostic Testing

Diagnostic testing: Identifies current infection at the individual level and is performed when a person has signs or symptoms of infection, or when a person is asymptomatic but has recent known or suspected exposure.

Screening testing: Looks for individual infections in a group even if there is no reason to, Testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions based on the test results.

Test developers decide the use they will seek to have authorized by the FDA.

The FDA issued a new supplemental template for test developers seeking EUA of certain tests for screening with serial testing.

FACT SHEET

CURE ID App receives award

 CURE ID is an internet-based repository for clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases

• Collaboration between FDA, National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), and World Health Organization (WHO)
• Critical updates to app to allow clinicians to more easily report their real-world experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial
• Received 2021 Golan Christie Taglia Patient Impact Philanthropy Award

App

Image credit: FDA, Tiger Tech, BioFire