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Next-Generation Digital Diagnostics

Detecting Multiple Pathogens simultaneously without enzymes, amplification or reagents

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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

Current Achievements

1

How It Works

Patients and other end-users deposit a small saliva sample into the Check4® device, which is about the size of a cell phone. If targeted DNA or RNA is present in the saliva, electrical signals passing through the graphene trigger a molecular reaction with highly accurate and immediate results. If the pathogen is absent in the saliva, no molecular reaction occurs, and the test is negative. Future plans include the ability to test through other bodily fluids.

The reactions among the genetic material are unmistakable. A cloud-based algorithm verifies the data and sends results to a user’s cell phone or to a clinical database in minutes. These sensors use no chemical additives and can be easily functionalized by the manufacturer for COVID, Flu, RSV and a host of other infections, including HIV, Lyme and hepatitis.

2

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.

3

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.  

PRICING STRUCTURE

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.

Reusable reader

$160

Disposable test cartridges

$60

REGULATORY APPROVALS

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.

PATENT PORTFOLIO

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

4

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

MANUFACTURING WITH JABIL HEALTHCARE

IdentifySensors Biologics has partnered with Jabil Healthcare (NYSE: JBL), one of the largest medical device manufacturers in the world. Jabil and IdentifySensors Biologics® are working together to begin scaling production of the readers and multiplex test cartridges.

In tandem, IdentifySensors® will continue developing test cartridges beyond COVID and other respiratory illnesses, such as MRSA, Legionella and Hepatitis C

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 plans to roll out product in 2023. 

  • Point of care 
  • Over-the-counter

THE FUTURE OF DIGITAL DIAGNOSTICS

Diagnostic specialists and public health agencies have long sought an ideal testing platform: a comprehensive technology that performs three critical functions simultaneously: 1) rapid multiplex 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 from a single simple of saliva or other bodily fluids, performed at home and monitored remotely, will dramatically change the future of digital molecular diagnostics for decades.   

Graphene sensors developed by IdentifySensors Biologics® have the potential to reach these major goals. The company is currently focused on the first stage of detection – direct multiplex pathogen diagnosis – but a longer vision could have profound significance worldwide.

  • Rapid multiplex detection in a single testing platform
  • Rapid biomarker detection and T-Cell recognition
  • Remote monitoring with instant results
  • Eliminates expensive and time-consuming lab work
  • Patients never leave their homes
  • Clinicians prescribe treatment remotely