Press Release
| BV follow-up study results published
in leading medical journal -
15th December 2004 |
Osmetech plc, (“Osmetech” or “the Company”)
the international diagnostics business, announces that the
excellent results of a clinical study for its Bacterial Vaginosis
(BV) sensor device have been reported in the latest edition
of the leading international publication, the Journal of
Clinical Microbiology.
In 2003, Osmetech received 510(k) approval
from the US Food and Drug Administration (FDA) for the
use of its conducting
polymer gas sensing (‘electronic nose’) device
for determining a patient’s BV status. In this follow-up
study the BV sensor device was effectively used to measure
the levels of BV at regular intervals for patients undergoing
treatment for the condition.
The study, conducted at the Baltimore City Health department
and Johns Hopkins University, Baltimore, USA, showed a very
strong agreement between the results of the Osmetech test
and those of the two established clinical methods of diagnosing
BV: Amsel criteria (98% agreement) and Nugent score (94%
agreement). These two current methods of testing have important
limitations, being subjective, difficult and time-consuming
to perform, requiring a high degree of expertise.
In conclusion, the Osmetech BV sensor device is as accurate
as present techniques for measuring BV and for tracking the
recovery of the patient throughout the course of treatment.
Furthermore the simplicity of the test has the potential
to be translated into an office based system.
James White, Chief Executive, Osmetech plc said:
‘This study demonstrates the effectiveness of Osmetech’s
BV sensor in not only diagnosing BV, but also in assessing
the patient through the treatment phase. The test is both
objective and simple to perform, overcoming the principle
shortcomings of existing testing methods. It also has the
potential to become the first ‘gold standard’ test
for BV diagnosis.
‘This is further validation of Osmetech’s electronic
nose technology. Following last year’s highly successful
acquisition of the OPTI business and the recent acquisition
of Molecular Sensing plc, we now have three core technologies
to enable us to provide product to satisfy the requirements
of the global healthcare market.
‘We are currently focussing on
near-term revenue generation but are delighted to have
further third party verification
of another potential opportunity for the conducting polymer
technology in the point of care healthcare arena.’
Enquiries
Osmetech
James White, Chief Executive 0207 849 6027
madano partnership
Matthew Moth 0207 378 7033
Notes to Editors
- Bacterial Vaginosis
(BV) is the most common cause of vaginitis symptoms
among women of child bearing age. The
condition affects 10-15% of women in the general female
population, but an incidence as high as 40% has been
reported among women
attending sexually transmitted disease clinics. BV
is associated with an increased risk for a host of obstetric,
gynaecological,
and neo-natal complications, including postoperative
infection following hysterectomy, miscarriage, pre-term
birth, post
abortion pelvic inflammatory disease, plasma cell endometritis
and human immunodeficiency virus infection.
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