Unlocking Personalized Cancer Care
Overview
For decades, cancer diagnostics have relied on complex, amplification-based lab workflows to identify genetic alterations that guide therapy. While sensitive, these PCR-based methods are slow, episodic, and limit timely access to actionable genetic insight.
Check4® is a digital diagnostic platform delivering PCR-level sensitivity for clinically actionable cancer gene mutations in minutes—without PCR workflows.
Direct molecular recognition enables high-sensitivity mutation testing without amplification or complex workflows.
Printed electronic semiconductor sensors directly measure molecular interactions, enabling rapid detection of druggable cancer gene mutations.
A recent breakthrough in single-nucleotide discrimination at low target concentrations enables Check4’s focus on oncology, starting with EGFR (non–small cell lung cancer), KRAS (non–small cell lung and colorectal cancer), BRAF (melanoma and colorectal cancer), and HER2 (breast and gastric cancers).
Designed as a companion diagnostic platform, Check4 supports therapy selection, resistance monitoring, and minimal residual disease assessment through a scalable, cartridge-based system paired with cloud algorithms and learning.
Built to scale, the platform is designed to expand across additional cancer targets—including precision mutations (PIK3CA, TP53, MET) and fusion mutations (ALK, ROS1, RET)—and broader molecular applications over time.
Check4 is under development and has not yet been approved for sale in the United States.
IdentifySensors' senior advisor, William Shatner, speaks on the company's new ability to instantly detect cancer.
AT A GLANCE
Digital biosensors intend to rapidly detect multiple infectious diseases and cancerous biomarkers from saliva or blood on the molecular level.
Microchips made from graphene are printed into solid-state, semiconducting biosensors.
Rapid tests are expected to surpass Limit of Detection performance of current PCR tests.
Cost of goods and pricing is targeted well below PCR tests.
Inteneded for early detection of cancers, viruses and bacteria.
FDA submissions was initiated in Q2 2025.
Rapid multiplex testing for point-of-care and over-the-counter markets.
Results sent to smartphones, remote dashboards or a clinical database.
A platform technology that wil be introduced as a SaaS model.
Data capturing capabilities to support research and managing population health.
HOW IT WORKS
CHECK4-RESULTS
A patient or clinician inserts a small saliva sample or blood into the Check4® test cartridge. If target DNA or RNA is present in the sample, digitial signals from the 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 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. The results in preliminary studies have been nearly immediate. Accurate and rapid results can help lower costs and increase the speed for treatment.
Device GalleryGO-TO-MARKET STRATEGY
CHECK4-PLATFORM
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 diseases or cancerous biomarkers. Users will be charged for results on a SaaS platform model.
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 diseases when the cartridge is connected to a reader. A Luer Lock syringe and sample 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 saliva or blood 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
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 and cancer 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 authorized by the U.S. FDA or other international regulatory authorities, but submissions to the FDA were officially initiated in 2025.
The Check4® testing platform intends to rapidly detect multiple diseases 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 disease.
This technology offers businesses, events and other gatherings the potential to test attendees remotely before clearing for entry, such as a cruise ship. It is intended that health-care agencies will be able to access population-health data for infection control and spread prevention in an epidemic or pandemic.
REGULATORY APPROVALS
IdentifySensors® Biologics initiated regulatory submissions with the U.S. FDA in Q2 2025. 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 2026.
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 disease 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 blood, 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 cancer and population health in the future.
News
IdentifySensors® is still accepting investments.
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