Enigma Diagnostics to Develop Clinical Diagnostics Platform for UK National Chlamydia Screening Programme

Saturday, November 10, 2007 General News
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PORTON DOWN, England, November 9 Enigma Diagnostics, thelife sciences company developing rapid molecular diagnostics and detectionsystems, announces that it has successfully completed a project commissionedby the Defence Science and Technology Laboratory (Dtsl) to develop a rapid,point-of-care diagnostic system for screening and diagnosis(1) of Chlamydiainfections, the most common treatable sexually transmitted infection (STI) inthe UK. The project was designed to meet the needs of the UK NationalChlamydia Screening Programme (NCSP), part of the National Strategy forSexual Health and HIV.

(Photo: http://www.newscom.com/cgi-bin/prnh/20071109/281128 )

Enigma has developed a specific DNA test (assay), reagents andinstrumentation capable of rapidly detecting Chlamydia trachomatis DNA frommultiple urine and, uniquely, swab samples at the point of care (PoC), i.e.in a clinic or outreach centre. Feasibility of the assay has been proven inthe laboratory and the product specifications have been validated with sexualhealth professionals.

The new system will be based on Enigma's fully-automated diagnosticsplatform, which uses real-time polymerase chain reaction (PCR) technology todetect bacterial target DNA in samples and provides definitive results in amatter of minutes, enabling immediate treatment as necessary. The system willalso be very simple to use, requiring minimal training and experience, andimportantly will provide 'gold standard' laboratory quality results therebyreducing the need for samples to be sent to a laboratory for analysis. Otherpoint of care diagnostics products for Chlamydia are known to give unreliableresults.

John McKinley, Chairman of Enigma Diagnostics, said: "This successfullycompleted contract with the UK Government demonstrates the utility ofEnigma's innovative molecular diagnostics and detection technology. We willdevelop a system that rapidly and simply delivers laboratory quality resultsin a clinical environment and therefore meets the needs of the UK NationalChlamydia Screening Programme where speed, sensitivity and simplicity are ofcrucial importance."

Notes to editors:

About Chlamydia and the NCSP

Genital Chlamydia trachomatis is the commonest sexually transmittedinfection (STI) in England and a significant proportion of cases,particularly among women, present no symptoms. It is easily treated withantibiotics if detected early enough, but if undetected and left untreated,Chlamydia infection can lead to more serious health problems, such as damageto the fallopian tubes, which can lead to infertility or ectopic pregnancy.In addition, 10-30% of infected women develop pelvic inflammatory disease.Chlamydia infection is also the most common cause of inflammation of thetesticles in men under 35.

The National Chlamydia Screening Programme is part of the UK governmentDepartment of Health's National Strategy for Sexual Health and HIV. Theprogramme aim is to implement and monitor opportunistic screening for genitalChlamydia trachomatis infection for young women and men in selectedprogrammes in England. Ten opportunistic screening programmes wereimplemented in 2002, with a further 16 programmes announced in January 2004,covering more than 25% of Primary Care Trusts in England. Phase 3 of theprogramme saw another 50 sites established bringing the total toapproximately 80 sites covering the whole of England. Full screening beganacross England in April 2006.

About Enigma Diagnostics

Enigma Diagnostics Limited is a private UK based company developing thenext generation of rapid diagnostic instrument platforms for the detectionand identification of infectious organisms, such as bacteria and viruses, inclinical, environmental and biological samples.

Enigma's innovative and proprietary technology combines the speed andsensitivity of real-time PCR (polymerase chain

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