Enigma Diagnostics Limited

About Enigma

Enigma was founded in 2004 and is located at Porton Down, Salisbury, UK. The Company is a Private Public Partnership, the shareholders being UK Government (Dstl) and private venture capitalist, Porton Capital Technology Fund.

Enigma Diagnostics Limited is a recognised leader in developing rapid diagnostics for the detection and identification of infectious organisms, such as bacteria and viruses, in environmental, clinical and biological samples.

Enigma develops portable and totally automated PCR (polymerase chain reaction) based diagnostic instruments that provide rapid and decisive results in real time allowing the user to take immediate action at the point of care.

Enigma's innovative and proprietary PCR technology offers a broad range of applications in a number of multi-billion pound markets.

The technology was originally developed for bio-security applications, and the Company is now targeting the clinical, veterinary, defense and homeland security markets where sensitive and specific diagnostics information is required rapidly at the point of testing.

 Enigma's commercial objective is to maximise revenues from a continuous flow of rapid diagnostic point-of-care and in-field products.

Enigma will follow a dual commercialisation strategy of building an in-house sales and marketing capability to direct distribution of its bespoke products and to partner with market leaders where global penetration of markets is required.

Enigma believes:

Molecular diagnostics needs to move towards:

• User friendly processes
• Fully integrated, flexible and portable equipment
• Simple sampling and testing at the point-of-care or in-field
• Rapid result calling <45 minutes

Molecular diagnostics needs to move away from:

• Highly skilled technicians in specialised laboratories
• Large, inflexible and complex equipment
• Slow result calling > 1 hour
• Lack of integration of sample preparation, amplification and detection steps in one device.

Enigma Instruments

Simpler, easier PCR

With a pipeline of platform technologies representing the next generation of integrated PCR products, Enigma is rapidly turning point-of-care and in-field molecular testing from early concept into reality.

Enigma’s simple-to-use products are specifically designed to deliver on-site results to first responders, security personnel, clinicians and veterinary professionals after minimal training.

Analysing the sample is a simple 30 minute, three-step process that minimises hands-on time:

1. Dispense sample into a single-use cartridge
2. Load cartridge, select test and walk away
3. Result conveyed via simple traffic light system

Enigma's most advanced instrument is Enigma FL which is designed for defence and homeland security and veterinary diagnostics applications. Enigma is also currently developing clinical diagnostics products to be used in point-of-care screening programmes in hospitals, clinics and laboratories.

Multi-market opportunities:

• Clinical – infectious disease testing and tissue processing
• Defence and Homeland Security – monitoring bio-threat agents eg Anthrax
• Veterinary pandemics – detection of animal diseases eg Swine fever
• Food and Beverage – detect and determine the viability of food pathogens
• Agri-Diagnostics – identification of GMO
• Environmental monitoring – quantify environmental contaminants
• Pharmaceutical processing – detection of mycoplasma
• Forensic – scene-of-crime analysis

Enigma Minilab (ML)

The Enigma ML instrument delivers fully-automated results from swab samples in 30 to 60 minutes at the point of care and to the same standards as reference laboratories. This will mean that patients can be tested for a broad range of diseases including specific influenza subtypes in the community and receive appropriate treatment rapidly. Currently the existing network of government diagnostic laboratories, staffed by specialist operators, can often take several days before the results of tests are known. Operators of the Enigma ML system will not require specialist training.

Enigma Fieldlab (FL)

Enigma has developed the FL, a portable real-time PCR platform for ultra-rapid, in-field detection of bio and viral strains such as H1N1. The PCR-Light technology patents are protected under Enigma and Dstl. For the first time, DNA data is available at a time and place where the result can provide maximum value. PCR-light has detection times as low as 15 minutes from sampling.

Enigma Technology

Enigma Diagnostics has a focus on real-time polymerase chain reaction (PCR) technology, which has become the accepted gold-standard test for biological agents in clinical, veterinary and defence laboratories throughout the world.

Enigma’s growing range of innovative products combine the speed and sensitivity of PCR with the simplicity needed for field-based and point-of-care tests. These products are based on an extensive portfolio of proprietary real-time PCR technologies that include:

• Automated sample preparation
• Real-time PCR instrumentation
• Unique direct heating thermal cycling
• Novel real-time PCR chemistries
• Freeze-dried PCR reagents

Enigma technology can be applied to a wide range of different samples, such as blood, urine, water, soil and food.

Intellectual Property

Technologies

Enigma has an exclusive license from the Defence Science Technology Laboratory (Dstl) to a portfolio of patents that represent over 15 years of UK Ministry of Defence funded research. Enigma’s own R&D activities have added additional proprietary technologies to generate a strategically important portfolio of over 35-plus worldwide patents and patent applications dedicated to real-time PCR. Many of these patents are granted in key territories such as US, EU and Japan.

This extensive pipeline of platform technologies represents the next generation of miniaturised & fully integrated molecular diagnostic products.

Due to the broad applicability of these proprietary technologies, Enigma has an established out-licensing programme and can tailor licensing agreements and development collaborations to meet the needs of our partners.

Key proprietary technologies:

Electrically Conducting Polymer (ECP)

• Unique direct heating technology
• Rapid, miniaturised thermal cyclers and lab-on-a-chip systems

Cell Viability

• PCR technology to determine bacterial cell viability

Bioluminescence PCR

• The future, low-cost platform chemistry for point-of-care testing
• Cheap digital camera replaces fluorimeter

ResonSense

• Validated platform chemistry for diagnostic & lab markets

Freeze Drying

• Stabilized, ambient stored PCR assays
• Eliminates frozen reagents

ImmunoPhage PCR

• Quantitation of proteins & biomarkers at PCR sensitivities

Sample preparation

• Magnetic bead and fluidic based nucleic acid sample preparation

Lab-on-a-chip

• Miniaturised multi-well technology for rapid thermal cycling

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