A New Digital
Diagnostic Platform
Overview
For the past 50 years, medicine has relied on complex chemical tests to detect infections. The process requires enzymes, amplification and trained clinicians to administer and analyze results. Soon, tiny electronic circuits that trigger instant results when placed in contact with saliva are intended to change the future of diagnostics.
Check4Pathogens by IdentifySensors® Biologics is a digital diagnostic platform intended to rapidly detect and differentiate multiple infections simultaneously at the molecular gene level.
Patented technology eliminates enzymatic amplification and reagents. Graphene-based electronic circuits are printed into solid-state semiconductors that become biosensors. The technology is intended to move diagnostics away from chemical testing and into a rapid multiplex digital platform with a lower limit of detection than the most accurate PCR tests on the market today.
In extensive preliminary studies, electronic biosensors pinpointed target DNA and RNA in saliva almost immediately. These biosensors serve as the core to a new Bluetooth portable device intended for point-of-care and over-the-counter use.
The company plans to expand the platform to rapidly detect genetic material from dozens of infectious diseases, including respiratory illnesses, diarrheal pathogens and sexually transmitted diseases.
With cost of goods significantly lower than current molecular tests, Check4Pathogens is intended to disrupt the PCR market. This technology has not yet been approved for sale in the United States.
AT A GLANCE
Digital biosensors intend to rapidly detect multiple infections from saliva and other bodily fluids
Sensors made from graphene-based inks and printed into solid-state electronics
Rapid tests are expected to surpass LOD performance of current PCR tests
Pricing is targeted well below PCR tests
No enzymatic amplification or reagents
Multiple FDA submissions are planned for 2024
Rapid multiplex testing for point-of-care and over-the-counter markets
Results sent to smartphones, remote dashboards or a clinical database
Potential integration with health data networks
Potential data capturing capabilities to help mitigate infectious disease spreading
HOW IT WORKS
CHECK4-RESULTS
Step One
A patient or clinician inserts a small saliva sample into the Check4® test cartridge. If target DNA or RNA is present in the saliva, digitial signals passing through biosensors trigger a measurable reaction. An algorithm in the cloud determines the results. If pathogen genes are absent, a molecular reaction cannot occur, and the test is deemed negative.
Step Two
After the cloud-based algorithm interprets the data, the system sends test results to the user by text or email in minutes. The biosensors use no chemical additives or amplification, so the results in preliminary studies have been nearly immediate. It is intended that this technology will help medical professionals rapidly and accurately diagnosis patients. Accurate and rapid results can help lower costs and increase the speed for treatment.
Device GalleryGO-TO-MARKET STRATEGY
CHECK4-PLATFORM
The Check4® testing
platform includes two main parts:
1) The reader, which can be reused many times, serves as the base of the platform. It accepts any number of different cartridges that test for different pathogens.
2) The test cartridges, which are used when connected to the reader, are single-use, disposable devices that identify single or multiple infections in saliva. They are intended to be sold separately. Pricing for both units is intended to fall well below current molecular tests, such as PCR.
Bluetooth Reader
The Bluetooth reader can be reused many times. It reads test data from the cartridge and serves as the base for the testing platform. When connected to the Check4® mobile app, the reader communicates results to an interpretive algorithm in the cloud.
Disposable test cartridges
A test cartridge can contain one or more digital biosensors. The sensors are intended to detect and differentiate multiple pathogens from saliva when the cartridge is connected to a reader. A Luer Lock syringe and saliva collector is included with each cartridge.
Saliva Sample Collector
A sample-collection device is included with each test kit. It includes a collection cup and a standard Luer Lock syringe to insert a saliva sample into the cartridge when testing.
Check4 Reader App
The Check4® Reader app uses Bluetooth to connect the reader to each user account in the cloud. An algorithm within the system interprets data from the cartridge and sends test results to users by text or email.
Core Features
Intended for high SENSITIVITY
During research-and-development studies, clinical samples were taken from patients at the Indiana Medical Center and tested for a pilot respiratory study to evaluate the limit of detection for the Check4® platform.
Using highly sensitive quantitative PCR tests, clinical samples were diluted to 200 gene copies per milliliter and tested on the Check4® platform. The clinical trials yielded 99.9 percent at a sensitivity well beyond the capabilities of most PCR tests.
This groundbreaking technoloigy is intended to detect infections well before patients show symptoms and help slow the spread of disease. Statements relating to this performance are on record and based on pilot testing. They have not yet been evaluated by the U.S. FDA or other international regulatory authorities.
REMOTE CAPABILITIES
The Check4® testing platform intends to rapidly detect multiple pathogens digitally, enabling results to be seen remotely on a mobile smart device, a clinical database or an organization’s dashboard. It is intended that patients will be able to test at home and send test results to clinicians without risking infection or spreading.
This technology offers businesses, events and other gatherings the potential in the future to test attendees remotely before clearing for entry, such as on a cruise ship. It is intended that health-care agencies will be able to eventually access population health data for infection control and spread prevention in an epidemic or pandemic.
REGULATORY APPROVALS
IdentifySensors® Biologics plans to pursue several regulatory submissions with the U.S. FDA. The Check4® product portfolio is not yet currently commercially available.
PATENT PORTFOLIO
Patents
IdentifySensors® maintains an extensive and growing patent portfolio, reflecting a wide ranging freedom to operate and an ongoing commitment to innovation and technological advancement. New patents are continuously added as we develop and protect our latest breakthroughs. Existing patents include:
Issued Patents
Pending Patents
10 additional patents pending being prosecuted globally
GOING TO MARKET
IdentifySensors® Biologics has developed its Check4® testing platform for two principal markets: over-the-counter sales and point-of-care use in clinical environments. The company intends to introduce product in 2024.
Point of care
Over-the-counter
THE FUTURE OF DIGITAL DIAGNOSTICS
Researchers at IdentifySensors® envision an ideal testing platform -- a comprehensive technology that performs three critical functions simultaneously: 1) rapid multiplex pathogen detection; 2) identifying specific biomarkers that predict illness severity and; 3) detection that measures a patient’s response to vaccines.
Obtaining this breadth of information rapidly from a single sample of saliva or other bodily fluid, performed at home could dramatically change the future of molecular diagnostics.
Printed solid-state biosensors on graphene-based inks hold the potential to eventually reach these milestones. IdentifySensors® is currently focused on the first stage of detection – direct multiplex pathogen diagnosis. But a longer vision for this same technology could have a profound impact on indivual patients and population health in the future.
News
IdentifySensors® is still accepting investments.
Help advance this technology and accelerate the development and marketing of new products.
