Check4® by IdentifySensors® Biologics is a digital diagnostic platform intended to rapidly detect and differentiate multiple pathogens simultaneously at the molecular gene level.
New patented technology eliminates enzymatic amplification and reagents. Graphene-based inks are printed into solid-state electronic biosensors. The technology is intended to move diagnostics away from chemical testing and into a rapid multiplex platform, with a lower limit of detection than the most accurate PCR tests on the market today.
In extensive preliminary studies, printed sensors on thin-film substrates pinpointed target DNA and RNA in saliva in minutes. These new sensors 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 a target price lower than current molecular tests, Check4® is intended to significantly disrupt the PCR market. This technology has not yet been approved for sale in the United States.
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 2023
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
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.
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.
Dubbed a miracle material by renowned scientist, Dharani Sabba, graphene-based compounds are dramatically advancing the fields of electrical transmission, power generation, energy storage and soon digital biosensors. Comprised of a single layer of carbon atoms and arranged in a honeycomb pattern, graphene and graphene-based inks serve as a super conductor that make them the thinnest, strongest and most conductive materials in the world. Scientists at IdentifySensors® Biologics have developed patented ways to print graphene-based inks into biological electronics. These tiny biosensors serve as the core of the Check4® test cartridges. When sensors are functionalized to detect targeted RNA or DNA, such as the COVID-19 virus, molecular reactions on the sensors are instantly identifiable through a precise and digital application.
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.
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.
Intended for high SENSITIVITY
During research-and-development studies, SARS-COV-2 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.
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.
IdentifySensors® Biologics plans to pursue several regulatory submissions with the U.S. FDA later throughout 2023 and 2024. The Check4® product portfolio is not currently commercially available.
IdentifySensors® holds seven issued patents, with 10 more pending, all of which cover multiple aspects of the solid-state digital biosensors and methods used to prepare, detect, digitize and communicate the presence of pathogens with DNA or RNA.
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
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) T-Cell 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.