August 24, 2012

Today’s biggest cancer breakthrough

Stuff is reporting on a software system called Volpara for improving breast-cancer screening, from Wellington company Matakina (and 3News had a similar story).  The software is designed to give more reliable and objective estimates of breast density, with less variation due to different equipment or different radiologists.  This should be helpful in screening younger women, either to improve detection of tumours or to reduce false positives, and the software seems to have been quite successful commercially.

Medical progress is pretty incremental: even the best ideas and techniques tend to have relatively small impact on health, so while it’s good to see NZ medical contributions being recognised, it’s also useful to put them in context.  Judging from the research papers linked from the Volpara website, there isn’t any hard evidence yet that the software gives better diagnoses.  There’s good evidence that women with denser breasts are more at risk from cancer and that it’s harder to diagnose, and Volpara seems to give better measurements of density, which theoretically should help, but they don’t currently know for sure.

The hook for today’s story is that the system is being used for screening in the Netherlands: a big success for the company both commercially and in demonstrating that international radiologists think the system is good.  The story in Stuff and the company’s press release differ a bit on the details:  Stuff says

Volpara is already in clinical use in the United States, South Korea and Malaysia and in a clinical trial in the Netherlands to become part of the national Dutch breast-screening system. It will be screening up to 1 million Dutch women a year at 67 sites.

the press release says

Approximately one million women are screened every year in the Netherlands. For the trial, breast density will be assessed using the Volpara Imaging Software in a subset of the screening units.

And the trial isn’t to see how well Volpara works, it’s to see whether contrast-enhanced MRI improves diagnosis in women with denser breasts.

Finally, the story ends up

The software had to go through intensive testing before it got approval from the United States Food and Drug Administration in late 2010.

 This is a major hurdle, but it’s important to note that this doesn’t mean the FDA assessed whether Volpara works better (or even as well) for cancer diagnosis.  The system was approved based on “substantial equivalence” with an existing system for measuring breast density.

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Thomas Lumley (@tslumley) is Professor of Biostatistics at the University of Auckland. His research interests include semiparametric models, survey sampling, statistical computing, foundations of statistics, and whatever methodological problems his medical collaborators come up with. He also blogs at Biased and Inefficient See all posts by Thomas Lumley »