AIX-EN-PROVENCE, France--(BUSINESS WIRE)--SuperSonic Imagine presented yesterday the validation of a world wide multicentre study, based on European recruitment, confirming the benefit of ShearWave Elastography when added to ultrasound for improved lesion classification.
Launched by SuperSonic Imagine in June 2008, the global, multi-centre study was conducted across 16 American and European sites involving 1,800 patients with breast lesions.
The first major result of this study demonstrated that ShearWave Elastography is reproducible both quantitatively and qualitatively. This reproducible technology provides strong assurance of precise tissue evaluation during diagnosis and is expected to be also useful in follow-up.
The second important outcome is a statistical model based on 939 lesions, which showed that ShearWave Elastography increases the performance of ultrasound breast cancer diagnosis. The addition of ShearWave Elastography features, such as maximum elasticity (stiffness) or heterogeneity (uniformity) of a lesion, to B-mode ultrasound, would permit an improvement in the BI-RADS® classification accuracy, (standardization tool for breast lesion classification from the American College of Radiology) improving breast diagnosis.
European results validate the conclusions of the model
In Europe, 1,223 lesions have been examined, including 425 cancers (34.8%). The European study was conducted across four sites in France (332 lesions), four sites in Germany (585 lesions), one site in Italy (104 lesions) and one site in United-Kingdom (202 lesions).
The application of the model to this sub-group demonstrates the importance of the maximum elasticity value. When added to the BI-RADS® score, this value:
- Maintains the sensitivity* of the ultrasound exam (97.9%)
- Increases its specificity* by more than 8 per cent (59.9% to 68.2%)
- Maintains its negative predictive value* above 98%
- Increases its positive predictive value* by more than 5 per cent (73.1% to 78.5%)
These results confirm the increase in specificity expected with the addition of ShearWave Elastography features to BI-RADS® criteria and consequently the reduction of the rate of negative biopsies. In addition, ShearWave Elastography can assist in diagnosing cancers that would have otherwise fallen into a follow-up category, thus earlier intervention and treatment could occur with significant implications for patient management.
Sensitivity = ability to find malignant lesions
Specificity = ability to find benign lesions
Negative predictive value = reliability of the benign test
Positive predictive value = percentage of lesions correctly classified
About SuperSonic Imagine:
Founded in 2005 and based in Aix-en-Provence, France, SuperSonic Imagine is an innovative, multinational medical imaging company dedicated to developing a revolutionary ultrasound system: the Aixplorer®. This system leverages a unique MultiWave™ technology that enables the user to detect, characterize and, in the future, treat palpable and non-palpable masses. This unique technology is based on combining two types of waves: an ultrasound wave that provides exceptional imaging in B-mode, and a shear wave which measures and displays the stiffness of tissue in kilopascals (ShearWave Elastography ™). Engineers from all over the world have joined the SuperSonic Imagine team and the company now has offices in Aix-en- Provence, Seattle, London and Munich. In addition to a successful direct sales in France, Germany, USA and UK, SuperSonic Imagine built a strong distribution network worldwide, including Hologic Inc. (Nasdaq: HOLX) for the breast care market in the USA as well as dedicated strategic partner Canon in Japan. SuperSonic Imagine holds the exclusive right, title and interest to 25 international patents and submissions in diagnostic imaging and therapy applications. SuperSonic Imagine is backed by strong financial, strategic and industrial investors, including Edmond de Rothschild Investment Partners (EdRIP), Auriga Partners, Crédit Agricole Private Equity (CAPE), NBGI Ventures, Bioam, Mérieux Développement, Wellington Partners, Innobio, Canon (NYSE:CAJ), and IXO Private Equity (formerly known as ICSO Private Equity).
For further information about SuperSonic Imagine please visit our website: www.supersonicimagine.com
Aixplorer is a next-generation ultrasound imaging system with unique technology that offers advantages in lesion detection and characterization. Using a method of imaging called ShearWave™ Elastography, Aixplorer can measure true tissue elasticity, in real time, providing quantifiable*, user- skill independent and reproducible results. The Aixplorer ultrasound system also provides impeccable images and sophisticated features all packaged in an ergonomic design, to assist in the imaging diagnostic process. Based on these innovations, Aixplorer now has six clinical applications: breast (and 3D breast), thyroid, abdomen, musculo-skeletal, prostate, and gynaecological (excluding obstetrics). In parallel to diagnostic imaging, researchers at SuperSonic Imaging are currently developing a noninvasive ultrasound therapy method, based on technology from Miroir à Retournement Temporel developed by Mathias Fink, a co-founder of SuperSonic Imagine. Aixplorer was named after its birthplace, Aix-en-Provence, in France. The Aixplorer has both CE mark approval since 2008 and FDA clearance since 2009.
For more information on SuperSonic Imagine and Aixplorer, please visit these sites: