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In Tough Diagnostics World, Will Ruling Out Cancer Be Good Business?

Xconomy National — 

The high cost of cancer treatments is a huge topic of conversation these days. One way to trim those costs is to not give treatments to people who don’t need them.

That sounds like a no-brainer, but it’s a knotty problem, and it’s at the heart of the current debate over the nationwide practice of screening large swaths of people for cancer when they don’t have any symptoms.

Proponents say finding tumors earlier is better, and people of a certain age have come to expect regular mammograms or PSA blood tests for prostate cancer. But while scans, blood tests, and other detection technologies grow more sophisticated and find more suspicious growths that might or might not be tumors, those findings aren’t necessarily leading to better health outcomes, as has been recently reported with mammograms.

Critics argue that all this testing detects growths that, if left alone, wouldn’t have done harm—they call this overdiagnosis—and say we should dial back the screening. Indeed, guidelines have in recent years shifted toward reducing the frequency and reach of PSA testing and mammograms, not without controversy. (Guidelines for breast screening remain in flux.)

But the momentum is heading the other way with lung cancer, which is the biggest cancer killer in the U.S.

Prompted by studies that suggest an overall benefit of regular screening of high risk people (that is, heavy smokers), the U.S. Medicare system recently ruled it would begin paying for annual lung CT scans, a type of X-ray, as well as counseling. The new rules could add an estimated 8 million people to the mix of those already getting tested.

Based on previous evidence, as many as 25 percent of them will have nodules show up on their scans, and those nodules will often prove to be ambiguous, in a gray area between benign and malignant.

Those ambiguous scans will likely send a patient into more invasive tests, that is, various kinds of biopsies.

And therein lies a market opportunity: to resolve the ambiguity as soon as possible, sort out the benign lesions, and prevent a large percentage—perhaps as much as 30 percent—of those scanned from incurring more costs and more risk of something going wrong, like a lung collapse or puncture. (In this study, 23 percent of patients undergoing surgery to remove a suspicious lung nodule ended up with a benign diagnosis. The mean cost per patient was $25,515.)

Those pushing back against overdiagnosis and overtreatment might have their own technology to bring to the fight: New molecular tests that can tell someone who’s got suspicious lung nodules if he or she doesn’t have cancer and route them, like drivers sent to a side street to avoid a damaged bridge, away from unnecessary procedures. (There’s also a test to do the same with thyroid nodules, as we’ll see.)

New “rule-out” tests, based on genomic or proteomic analysis, are for now a very small piece of the diagnostics business. Only two companies—which are also competitors—have brought them to market, and only in cases of suspected thyroid or lung cancers. But with the new Medicare rules, the need for such tests in the lung cancer space could be significant.

One prominent critic who argues for less cancer testing, generally, says he would make a cautious exception for genetic rule-out tests.

“It’s a great direction to move, and intellectually I can appreciate the effort,” said Gilbert Welch, a professor of community and family medicine at The Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, NH. “But the question is how well [do they] perform, and how do we decide whether the tests actually work?”

Welch, who wrote “Should I Be Tested For Cancer?” and more recently “Overdiagnosed: Making People Sick In the Pursuit of Health,” would like to see long-term follow ups of the people whose suspicious lung or thyroid nodules are deemed benign by rule-out testing.

He’ll have to wait a while. There aren’t any significant data, because the lung tests are too new. There’s one study of a thyroid test, which we’ll get to in a bit.

But first, a quick primer on lung scans. I mentioned that a quarter of all scans detect something. The guidelines for determining whether a lesion is benign or malignant are in flux, with new suggestions published earlier this year by the American College of Radiology.

The guidelines are complicated, but suffice it to say that nodules of single-digit millimeters in diameter probably aren’t worth intervention, and those patients go into a “watchful waiting” mode. Nodules more than 20 millimeters in diameter are red flags, and further investigation … Next Page »

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