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in the wake of the healthcare reform last spring. When Genomic Health talks about spending $4,000 on its test so that insurers can save a few thousand dollars per patient down the road, it might make logical sense, but a lot of bean counters naturally will fixate on why they are spending $4,000 in the first place for something that was never used before. After all, when more people are getting covered, overall costs go up, creating more pressure to scrutinize lots of expenses that may have been taken for granted before.
And Genomic Health has from time to time had to deal with the question of whether the FDA will try to exert more regulatory authority over its tests. The latest dust up came at a subcommittee hearing of the U.S. House Energy and Commerce Committee, which raised questions about whether to step up regulation of direct-to-consumer genetic tests like those offered by 23andMe and Navigenics. Without going into the alphabet soup of regulatory ideas, essentially Genomic Health’s test has been considered a laboratory developed test (LDT) and the FDA indicated after the hearing that it may issue new regulatory guidelines of LDTs. Genomic Health described the situation in the fine print of its latest 10-Q report with the SEC on page 30 and 31, for those who would like some more light reading on this.
Regulation of that kind could slow down the already slow and difficult road Genomic Health has to follow to really make money in this diagnostics field. But the potential is there to change how a lot of people think about healthcare, through actual applications of personalized medicine that are happening now, not 10 years in the future. Toward the end of our talk, Popovits was especially animated talking about a test for prostate cancer that is still at an earlier stage of development. If you could predict whether a man with prostate cancer has a slow-growing kind that almost surely won’t kill him, then you could guide the patient to avoid treatment that leads to all kinds of nasty side effects like incontinence and impotence. Giving men information about their prognosis could save a lot of unnecessary suffering, and expense, she says.
“This is going worldwide, it’s going to prostate, it’s going to renal, and it’s going to lung cancer,” Popovits says. “My personal feeling is this field on the verge of exploding, like biotech did.”
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