Schwitzer health news blog

Rush to market with ovarian screening test gets warning

American medicine's infatuation with screening tests - even sometimes in defiance of the evidence on harms and benefits - creates a crusading environment in which "Screen...screen...screen...earlier...earlier...earlier" is the mantra.

Now, the Wall Street Journal Health Blog reports the latest on the rush to market an ovarian cancer test. Excerpts:

"The FDA has warned clinical-test giant LabCorp that it has been marketing an ovarian cancer test (OvaSure) without approval, vindicating skeptics of the assay who worried it wasn’t ready for prime time.
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Researchers around the world have been racing to develop a test that will detect ovarian cancer early, because it usually isn’t found until it has already spread outside the ovaries, when it is very often fatal.
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Some cancer specialists fear OvaSure could yield too many false positives — causing women to undergo unnecessary exploratory surgery or to have their ovaries removed as a precaution — and false negatives, reassuring them when they might still be at risk.

“When you make a test available, then people are likely to make decisions based on the test,” said Rebecca Sutphen, a spokeswoman for the National Ovarian Cancer Coalition and director of genetic counseling and testing services at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla. “Obviously, everyone is on the same page in terms of wanting such a test. But women may be using this information prematurely to make decisions, and the decisions may not be in their best interests.”

The Society for Gynecologic Oncologists also issued a statement in July saying additional research was required before OvaSure was offered to women outside of research settings."