Next-Generation Digital Diagnostics
Detecting Multiple Pathogens simultaneously without enzymes, amplification or reagents
Check4® by IdentifySensors Biologics® is a next-generation digital diagnostics platform that detects multiple pathogens within 5 minutes on a genetic level through a digital reaction. The platform eliminates the need for enzymatic amplification and reagents. Graphene sensor technology has moved beyond chemical testing into a rapid digital platform as accurate as a PCR test but significantly more sensitive and cost effective.
Printed graphene sensors isolate targeted viruses and bacteria from saliva within a simple handheld, Bluetooth device. The platform detects the genetic material of dozens of pathogens for over-the-counter and point-of-care use.
At a fraction of the price of current molecular tests, Check4® is intended to replace PCR and antigen diagnostics completely. In the future, the platform can be functionalized to rapidly detect biomarkers and T-cell immunity to help clinicians predict infection severity and vaccine effectiveness among individual patients.
Facts at a Glance
Graphene sensors rapidly detect infections digitally
Breakthrough technology that is not PCR or antigen
No enzymes, amplification, reagents or lab work
Ultra-high accuracy and sensitivity from saliva
Half the cost of PCR tests
Multiplex – tests for multiple infections simultaneously
Test in about three minutes
Results sent to smartphones or a clinical database
Can be functionalized for direct diagnosis, biomarkers and T-cell immunity
Auto reporting for infectious diseases
How It Works
ULTRA-HIGH ACCURACY AND SENSITIVITY
Clinical tests used to determine the effectiveness of the Check4® platform for COVID were recently performed on sick patient samples from Indiana Medical Center. Each sample was verified positive or negative using PCR tests. Researchers at Purdue University diluted the samples down to 200 gene copies per milliliter with 99.9 percent test accuracy.
A typical PCR test detects infections down to about 900 gene copies per milliliter (limit of detection), making the graphene sensor more than four times more sensitive than PCR tests without amplification. This groundbreaking limit of detection enables highly accurate diagnosis well before patients show symptoms.
GRAPHENE IS CHANGING DIAGNOSTICS
Dubbed a miracle material by famous researcher, Dharani Sabba, graphene is comprised of a single layer of carbon atoms in a honeycomb configuration that makes it the thinnest, strongest and most conductive material in the world.
This super-conductor is dramatically changing the fields of electricity, electrical transmission, energy generation, batteries and sensors. Scientists at IdentifySensors® have developed a graphene application that triggers a reaction within genetic material when it interacts with an electrical current.
A small graphene surface, millimeters wide, serves as the sensor inside Check4® test cartridges. When sensors are functionalized to detect specific RNA or DNA, such as the COVID virus, the changes are instantly identifiable in a highly precise and effective digital application.
The Check4® platform comes is two main parts: A reader, which connects to a user’s cell phone or a clinical database; and a single-use test cartridge that contains up to four graphene sensors, each functionalized for a different infection.
The reader can be reused more than 20,000 times and will cost about $160. Each disposable test cartridge will cost about $60. With the ability to test multiple infections simultaneously, the pricing falls well below current molecular tests, such as PCR.
Disposable test cartridges
IdentifySensors Biologics® has begun working with the FDA in a pre-submission process with plans to seek approvals in 2023. The company is evaluating different FDA routes including Emergency Use Authorization for COVID, De Novo Classification and/or a 510(k) pathway.
IdentifySensors® holds seven issued patents, with six more pending, all of which cover multiple aspects of the graphene sensor and methods used to prepare, detect, digitize and communicate the presence of pathogens with DNA or RNA.
Seven issued patents
Six pending patents
REMOTE MONITORING CAPABILITIES
The Check4® testing platform detects pathogens digitally, enabling test results to be monitored remotely to a database or on a digital dashboard. Patients can test at home, while clinicians receive results remotely without risking infection or spreading.
Businesses, events and other gatherings can test attendees remotely before clearing for entry, such as on a cruise ship. Health care agencies can access population health data for infection control and monitoring.
Businesses and organizations can monitor test results remotely
Health organizations can access extensive population health data