Several new diagnostic tools aimed at distinguishing the aggressive prostate cancer tumors from non-life-threatening ones are becoming available, and more are in development, health specialists report.
One new test, called Oncotype DX, examines 17 genes in a tumor, and costs about $4,000. Although it is not typically covered by insurance, the company that created it, Genomic Health, offers a patient assistance program to help pay for its use for some,
The New York Times reports.
The test, which ranks tumors on an aggressiveness scale of zero to 100, “help tell us which ones are the bad guys,” as the Genomic Health co-founder Dr. Steve Shak put it.
Every year, about 220,800 American men receive a diagnosis of the disease, but up to half of all prostate cancers are not life-threatening, and most of those who have the disease do not die from it. The problem is doctors can’t always distinguish the life-threatening cancers from the slow-growing ones.
But new tests and diagnostic tools could change all that.
The Food and Drug Administration does not regulate tests that are developed and manufactured in a single laboratory, but the agency is seeking to extend its oversight into this rapidly growing field to ensure that these tests are accurate and reliable.
The new test are driven by the reality that the Prostate Specific Antigen, or PSA, blood test can be misleading, often suggesting cancer where there is none. Men who opt for surgery and radiation treatments for prostate cancer after such tests can have serious side effects, like incontinence and sexual dysfunction.
In 2012, a national task force found the risks of routine PSA blood screening tests outweighed the benefits, but last month, some experts expressed concern when studies found that fewer early-stage prostate cancers are being detected and fewer men are being screened.
One new test under development is a “liquid biopsy” — a minimally invasive test that can be performed on blood or urine and is capable of detecting “the prostate cancers that kill and need to be treated, versus those that don’t kill,” said Dr. Otis Brawley, chief medical officer for the American Cancer Society.
Researchers, working in collaboration with industry, are inching closer to this goal.
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