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Ovarian Cancer National Alliance

Take Action and let Congress know you want safe and reliable test results!

Report language nestled in a House Appropriations bill up for vote in committee this week would delay the Food and Drug Administration (FDA) from finalizing guidance to regulate laboratory developed tests (LDTs). The FDA's proposed guidance would ensure that LDTs are safe, accurate and reliable. A laboratory developed test is anything from a BRCA genetic test, to a CA-125 blood test. Click here to take action now.
 
Why is it important to have the FDA regulate LDTs?
These tests are increasingly used to guide complex medical treatment decisions. The consequences of inaccurate test results, such as false positives, can result in the unnecessary removal of a woman's ovaries. It is critical that patients know their test results can be trusted.

In November 2015, the FDA released a report: The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies, that outlines the harm that not regulating laboratory developed tests (LDTs) can cause to patients and to the economy. 


How have LDTs affected the ovarian cancer community negatively in the past?
The FDA report highlights what we in the ovarian cancer community already knew firsthand to be the danger of a test that hasn’t gone through FDA approval. OvaSure, an early detection test for ovarian cancer, came to market in 2008 without independent verification and oversight. This test didn’t accurately predict ovarian cancer cases, leading otherwise healthy women to have their ovaries removed based on bad information.
 
The report also brings to light evidence for two other faulty diagnostic tests for ovarian cancer, OvaCheck and PreOvar KRAS-Variant. Fortunately, OvaCheck was quickly pulled off of the market; however, PreOvar KRAS-Variant remains on the market despite insufficient evidence that it can accurately predict risk of ovarian cancer and response to treatment for women who are already diagnosed.

Click here to take action today to ensure that patients across the country receive reliable, safe and accurate test results to base their treatment decisions on!
 
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