Prostate HistoScanning(TM): Clinical performance confirmed
(Thomson Reuters ONE) -
The final results of the open phase of the Prostate HistoScanning(TM) European
multi-centre clinical study are published. The authors conclude that:
"...Prostate HistoScanning(TM) has the potential to benefit the prostate cancer
detection and staging pathway with increased cancer detection and tumour
localisation...".
WATERLOO (B), 13/12/2011 - Advanced Medical Diagnostics SA/NV (AMD), a privately
held company that has developed HistoScanning(TM), today announced the
publication of the final results from the open phase of the prospective, multi-
centre and pan-European clinical study (PHS-02[i]), evaluating the Prostate
HistoScanning(TM) application. HistoScanning(TM) is the award winning Tissue
Characterisation modality that utilises raw ultrasound data. HistoScanning(TM)
provides additional and meaningful information for better management of cancer
patients by providing visual reassurance for decision making.
The publication of the study in the British Journal of Urology International
(BJUI)[ii] marks the closure of the "un-blinded" or "open" phase of the study,
assessing the relationship between the size and location of lesions detected
with Prostate HistoScanning(TM) and those found at histopathology of the
prostate gland following its removal by pre-scheduled surgery.
The results establish a strong correlation between the total cancer volume
detected in each of the 27 glands by Prostate HistoScanning(TM) and by
histopathology.
At the level of individual cancer lesions, Prostate HistoScanning(TM) detected
25 of the 27 foci (91% sensitivity) that were greater than 0.20cc in volume.
More detailed analysis by prostate sextant examined the ability of Prostate
HistoScanning(TM) not only to detect and size, but also to accurately locate,
significant lesions and indicates that Prostate HistoScanning(TM) shows a
sensitivity of 90% and a specificity of 72% for the localisation of prostate
cancer foci within the 162 sextants (Table 1).
Table 1: Sextant analysis results for Prostate HistoScanning(TM) at differing
volume thresholds
+-------------------------------+ +-------+------------------------------------+
|Volume threshold ? | |?0.20cc| ?0.50cc |
|Performance indicator ? | | | |
+-------------------------------+ +-------+------------------------------------+
|Sensitivity | | 90% | 90% |
+-------------------------------+ +-------+------------------------------------+
|Specificity | | 72% | 70% |
+-------------------------------+ +-------+------------------------------------+
|Positive predictive value (PPV)| | 83% | 84% |
+-------------------------------+ +-------+------------------------------------+
|Negative predictive value (NPV)| | 82% | 80% |
+-------------------------------+ +-------+------------------------------------+
"We are delighted that the performance of Prostate HistoScanning(TM) has been
confirmed in this carefully executed study. In parallel, we have been
progressing with the final and "blind" phase of this study. We are pleased to
announce that it is in its last stages of recruitment and we look forward to
seeing the initial results early in 2012." said Dr. Dror Nir, Managing Director,
AMD.
This final, prospective "blind" phase will determine the value of Prostate
HistoScanning(TM) in a robust fashion, overcoming many of the biases inherent in
evaluating prostate imaging. "This rigorous study design has benefited from the
detailed guidance provided by the Principal Investigator, Professor Mark
Emberton[iii], and to the appointment of an independent data monitoring
committee based in Oxford (UK)," Dr. Nir continued.
This peer reviewed publication follows closely after the reporting of results
from seven centres in Germany, the Netherlands and United Kingdom at the annual
meeting of the Société Internationale d'Urologie (SIU) in Berlin (D) in October
2011. These independent study reports covered the use of Prostate
HistoScanning(TM) in diagnosis, to improve biopsy yield and in surgery planning
to reduce the rate of surgical positive margins.
About Advanced Medical Diagnostics SA/NV (AMD)
Advanced Medical Diagnostics SA/NV is a privately held company based in
Waterloo, Belgium. The company is dedicated, through its products, to improving
cancer patient management in a clinically meaningful and cost effective manner.
A dynamic and multinational team of experienced scientists, engineers and
business professionals is committed to bringing HistoScanning(TM) to medical
specialists and their patients around the world. It is their mission to provide
clinically meaningful localisation, quantification and visualisation of
differentiated tissues. It is their vision that HistoScanning(TM) will become a
standard of care and accessible for all patients around the world.
Press contact
Advanced Medical Diagnostics SA/NV (AMD)
Paula Wittels, Marketing Director
Waterloo Office Park, Drève Richelle 161, bat i, bte 3
B-1410 Waterloo
T: +32 23 528 030
F: +32 23 528 049
media(at)histoscanning.com
Bibliography and references
[i] The PHS-02 study is sponsored by AMD.
[ii] SIMMONS (L.A.M.), AUTIER (P.), ZÁT'URA (F.), BRAECKMAN (J.), PELTIER (A.),
ROMÍCS (I.), STENZL (A.), TREURNICHT (K.), WALKER (T.), NIR (D.), MOORE (C.M.),
EMBERTON (M.). 2011.Detection, localisation and characterisation of prostate
cancer by Prostate HistoScanning. Published online ahead of printing in British
Journal of Urology International (BJUI). 17/11/2011.
[iii] University College London (UCL), Dept. of Surgery and Interventional
Sciences, London (UK).
Press Release in PDF:
http://hugin.info/150258/R/1571040/488603.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Advanced Medical Diagnostics NV/SA (AMD) via Thomson Reuters ONE
[HUG#1571040]
Unternehmensinformation / Kurzprofil:
Datum: 13.12.2011 - 16:30 Uhr
Sprache: Deutsch
News-ID 96619
Anzahl Zeichen: 7124
contact information:
Town:
Waterloo
Kategorie:
Business News
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"Prostate HistoScanning(TM): Clinical performance confirmed"
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