Wednesday, February 29, 2012

For MRI, It's All About Efficacy

The use of any clinical diagnostic tool is rooted in its proven ability to enhance the diagnosis of a patient.  Efficacy drives procedures and procedures drive system sales.  A recent EVA (Evaluation of the Efficacy of Diagnostic Methods (Mammography, Ultrasound, MRI) tria of 700 has confirmed the efficacy of MRI  (Magnetic Resonance Imaging) in a key concern of the healthcare system - breast cancer, and thus Kalorama believes, the sales growth of these systems are no accident.  

" The results of the EVA confirm that MRI is substantially more accurate for early diagnosis of breast cancer than digital mammography or breast ultrasound: MRI is three times more sensitive for breast cancer than digital mammography," says our imaging analyst Joe Constance.   "Efficacy drives procedure volume and along with technological improvements to systems, is driving sales growth."

For the EVA trial, almost 700 women were enrolled. The goal of the trial was to refine existing guidelines for surveillance of women at high and moderately increased risk of breast cancer. Findings suggest that in these women, MRI is essential for early diagnosis, and that a mammogram or an ultrasound examination does not increase the cancer yield compared to what is achieved by MRI alone. Researchers conclude that annual MRI is not only necessary, but in fact sufficient for screening young women at elevated risk of breast cancer. In women undergoing screening MRI, mammograms will have no benefit and should be discontinued. Moreover, MRI screening is important not only for women at high risk, but also for those at moderately increased risk.

Between 2002 and 2007, the EVA trial recruited 687 women who carried a moderately increased risk of breast cancer – a life time risk of 20% and over. Women underwent 1,679 screening rounds consisting of annual MRI, annual digital mammography and half-annual screening ultrasound examinations. During this time span, 27 women received a new diagnosis of invasive cancer or ductal carcinoma in situ. Of all imaging methods under investigation -- digital mammography, ultrasound and MRI -- MRI offered by far the highest sensitivity. MRI identified 93% of breast cancers. About 37% of cancers were picked up by ultrasound. The lowest sensitivity was achieved by digital mammography, which identified only one-third of breast cancers (33%).

Kalorama Information's survey of both the MRI and Ultrasound markets, Medical Markets: MRI and Ultrasound, has just been published and can be obtained at