Bloodless Dx technology utilizes the whole body to detect and monitor for disease

The test acts as a tiny analyzer accessing unlimited sample flow-through

The human immune system is adapted to function as a real-time diagnostic indicator

Technology Brief:

Bloodless Dx has adapted the human immune system to function as a real-time diagnostic platform that can be activated to detect a variety of diseases. This platform, branded First Encounter, has been used to create tests that are invisible to the eye, active for weeks, highly robust and biodegradable. These tests are applied to the dermal layer of the forearm where the body naturally sets up its first line of defense. Each test acts as a tiny, invisible analyzer with access to an unlimited amount of sample.

This is the first point-of-care (POC) test, to our knowledge, that allows for pre-exposure monitoring and will reduce the uncertainty around testing asymptomatic populations. The assay turns positive when exposed to an analyte, whether that exposure occurs at the time of application or days, weeks, or possibly months later. A positive result indicates infection; if no reaction is observed the assay remains in place to detect future exposure, operating as a sentinel test. The “sentinel” ability of this technology provides new strategies for disease management and pandemic preparedness.

This technology:

Requires only 1-step to generate results

Eliminates sample collection (including blood, urine or any other bodily fluid)

Generates results within 60 secs (from unpackaging to results read)

Is an order of magnitude less complex to manufacture and use than rapid tests

Is painless to apply, invisible and remains active for weeks until triggered

Can be applied prior to infection and biodegrades on the expiration date

Exploits interstitial fluid, an underutilized, information-rich biofluid

Provides a new way of managing diseases, disease outbreaks and pandemics

Is simple and economical enough for anyone in the world to obtain and use

The technology utilizes bioengineered affinity reagents that are able to harness the exquisite sensitivity, specificity, and explosive signal amplification of immediate hypersensitivity reactions to detect almost any pathogen or analyte. Depending on the affinity reagent, the platform can potentially detect antigens, antibodies, nucleic acids and even act as a flow cytometer detecting migrating T-cell subtypes. Feasibility studies have demonstrated the detection of hepatitis B surface antigen in mice and Ara h 2 protein in humans. The sentinel capabilities of the test have also been demonstrated in both. The technology allows for multiplexing, is easily adaptable to sensor technology and provides a strategy for an on-site, handheld laboratory that can detect multiple analytes simultaneously with no need for sample collection.

Unique to this technology is the ability to control outbreaks and pandemics. Imagine, the first cases of a potential pandemic, such as SARS-CoV-2 virus, appear in your city. Over the next few days thousands of people apply First Encounter COVID-19 self-tests made available through pharmacies, food chains, ad hoc distribution centers, etc. As tests turn positive, the user self-quarantines, receives medical attention, and contact tracing is initiated effectively shutting down spread of the contagion. Similarly, a First Encounter sepsis test could be applied during outpatient procedures on patients susceptible to infection, monitoring for the earliest possible threat. Almost 90% of sepsis cases originate in the community and not in hospitals. Early recognition and prompt treatment remain the pivotal steps in reducing the societal and economic burden of sepsis worldwide. Other applications could have a significant impact on some of the most devastating diseases and illnesses facing mankind including tuberculosis, hepatitis, malaria, and HIV among others.

Applications

Tests are applied in one step using an allergy skin test device. Positive results are clearly visible as a wheal and fare reaction.

The technology can be used to detect a broad range of analytes for professionals or in-home use. A positive result indicates infection; if no reaction is observed the assay reagent remains in place to detect future exposure, operating as a sentinel test. The "sentinel" ability of this technology provides new strategies for disease management.

Potential applications of First Encounter technology:

Infectious diseases

HIV

P24 Early Infant Diagnosis

Hepatitis

SARS-CoV-2

Ebola

Tb-Lam

Stat Assays

Troponin

Procalcitonin

CRP

Veterinary Diseases

Feline leukemia virus

Canine heartworm

Other

• Sepsis early warning test
• Interferon-gamma release assay (IGRA) self-test
• T-cell subset identification
• Parasites
• Biowarfare agents
• Novel biomarkers
• Research

Background photo shows a typical example of a positive result from human feasibility studies.