Enigma Announces the Start of US Clinical Trials for Its Influenza A/B Detection Assay

MILTON PARK, OXFORD, England and SAN DIEGO, April 11, 2011 - Enigma Diagnostics announced today that it has commenced clinical trials
for its intended point of care Enigma(R) ML Influenza A/B detection assay.
Enigma will submit its application to the U.S. Food and Drug Administration
(FDA) for approval of the assay in 2012.

The Enigma(R) ML instrument platform combines fully-automated sample
extraction with real-time PCR amplification and detection system which has
been specifically designed for the particular needs of infectious disease
testing. The starting material for analysis is a capped tube containing
universal transport medium and a swab which uniquely is inserted directly
into the consumable cartridge. The test is anticipated to take less than 1
hour to perform and results are displayed in a number of simple to interpret
formats by the integrated touch-user interface screen. Current methods for
viral detection often require many manipulative steps for sample handling and
subjective interpretation from highly-skilled laboratory technicians which
can take several days to process from the time of collection. The Enigma(R)
ML system was specifically designed as a rapid fully automated system
enabling "raw sample to result" testing with uncomplicated read-outs and
allowing for lower technical skill users.

Clinical trial site initiations and the enrollment of subjects for the US
based trial began in late March after Enigma worked closely with the FDA on
the clinical trial design for both 510(k) clearance and potential CLIA-waiver
of the system. Up to 8 clinical study sites across the United States will
participate in patient enrollment and onsite testing of the Enigma(R) ML
system.

The clinical trial design consists of two phases. The first phase
includes the collection of nasopharyngeal samples at the end of the 2010-2011
flu season. The second phase will include additional collection of samples
alongside testing on the Enigma(R) ML system during the 2011-2012 flu season.
A total of 1,100 subjects including both adult and pediatric patients will be
enrolled in the trial.

John McKinley, Chairman and CEO, said, "It is estimated that over 12
million influenza tests are performed yearly in the USA and typically between
5 and 20 percent of the US population are infected with seasonal flu every
year. Faster and more accurate tests are needed to satisfy this growing
market and the features of the Enigma(R) ML instrument make it ideally suited
to meet this demand . With increasing market recognition of the importance of
achieving CLIA Waiver, we are pressing ahead with the clinical trials and
anticipate completion of our EU and USA regulatory accreditation processes
within 2012 to include FDA consideration of the appropriateness of the
Enigma(R) ML system to achieve CLIA Waiver status."

About Enigma Diagnostics Limited

Enigma Diagnostics Limited specializes in developing next generation
rapid molecular diagnostic instrument platforms for decentralized and
point-of-care settings. Enigma's innovative and proprietary technology
combines the speed and sensitivity of real-time PCR (polymerase chain
reaction) with the simplicity needed for decentralized and point-of-care
testing providing results from a raw sample in less than 60 minutes. The
Company is specifically targeting the infectious disease markets and
high-value Applied Markets. Enigma's commercialization strategy is to
maximize revenues from a global installed base of instruments with a
continuous flow of market leading rapid diagnostic assays for laboratory and
point-of-care settings. Enigma will partner with market leaders where global
penetration of markets is required and where appropriate, will engage
regional partners and build in-house sales and marketing capability to
directly distribute its products.

    For further information please contact:
    Josephine Deniau
    Communications Manager
    T +44-0-1235-854074
    communications@enigmadiagnostics.com
    www.enigmadiagnostics.com

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