Research Update
July 02 2001 - 3:30AM
UK Regulatory
RNS Number:1616G
Osmetech PLC
2 July 2001
2 July 2001
Osmetech Publishes Clinical Trial Data in Journal of Clinical Microbiology
In another first for an electronic-nose ("e-nose") company, UK-based Osmetech
plc ("Osmetech" or "the Company") announces that the results of clinical
trials of its unique array-based polymer sensor technology has been published
in the Journal of Clinical Microbiology.
The results of the trials, carried out at St Thomas' hospital, London,
demonstrate that the Osmetech's sensor technology can be used for screening
human samples for the presence of bacteria causing Urinary Tract Infections
(UTIs). The results obtained show that the Osmetech's Microbial Analyser (OMA)
achieved a 83.5% sensitivity and 87.6% specificity compared to conventional
culture detection methods.
The conclusion reached by the article's authors is that the OMA is a promising
automated system for the rapid screening of human specimens. Further clinical
trials have been undertaken aimed at refining the product and the Company has
submitted the results of these further trials in support of its application
for regulatory approval of the technology with the United States' Food and
Drug Administration (FDA).
A copy of the paper is available via the Company's website at
www.osmetech.plc.uk.
James White, Chief Executive, Osmetech plc said:
"Today's announcement is an important milestone in the progression of
Osmetech's revolutionary technology from "proof of concept" to approved
diagnostic test and yet another first for Osmetech and the e-nose industry.
"Publication of this article in the renowned Journal of Clinical Microbiology
lends further weight to the Company's recent FDA application and gives us the
opportunity to highlight to clinical practitioners and potential commercial
partners the excellent results achieved in trials of our UTI sensor
technology. "
Enquiries
Osmetech 01270 216 444
James White, Chief Executive
Bell Pottinger Financial 020 7353 9203
Rebecca Fox / Matthew Moth
Notes to Editors
Osmetech plc
* Osmetech plc designs, develops and manufactures electronic odour sensors
(electronic noses) for use in the healthcare sector. Osmetech's
multi-sensor array based gas sensing technology screens patient samples
and tests for the presence of infection-causing bacteria. The Company has
become a world leader in e-nose development, with the use of its
conducting polymers produced by the electro-polymerisation of derivatives
of polypyrole, polyaniline and polythiophenes.
* The Company, which is based in Crewe, is currently focusing its IP
development on sensors that can detect bacteria associated with a range of
healthcare applications, including urinary tract infections (UTIs) and
bacterial vaginosis (BV).
* In January 2000, Osmetech announced that the first set of trials of its
UTI sensor product had been successful. The trials, which were carried out
at St Thomas', London, and the Brigham & Women's Hospital, Harvard, USA,
enabled the company to obtain "proof of concept" status for its
technology.
* In October 2000, the Board of Osmetech announced that, following a large
proof of concept study at St George's Hospital Medical School, London,
Osmetech's BV Microbial Analyser matched the diagnostic performance of the
existing "gold standard" diagnostic test.
* In April 2001, the Company announced that it had submitted its UTI
sensor technology for approval by the FDA. Such approval of Osmetech's UTI
sensor technology would represent the strongest possible regulatory
endorsement of the Company's core technology. Contingent on receiving FDA
approval, Osmetech intends to bring its sensor technology to market, by
signing up a suitable licensing partner in the United States, where the
size of the healthcare market provides enormous opportunities.
Urinary Tract Infections (UTIs)
* UTIs represent the single largest test carried out by clinical
laboratories worldwide.
* At present the majority of UTI tests are culture-based, with patients
having to wait for 3-5 days to receive results. A rapid screening method
to exclude negative tests would save time and money, as well as allowing
doctors to provide an improved service to their patients. Osmetech's
point-of-care technology would mean that tests could be analysed at the
surgery or hospital and results given to patients immediately.
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