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Alyssa

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Alyssa

Re: MikeCr post# 196884

Thursday, 06/04/2020 11:32:23 AM

Thursday, June 04, 2020 11:32:23 AM

Post# of 205166
I believe it is allowed for research purposes while it awaits FDA approval.

The test did receive "Institutional Review Board (IRB) approval from the United States Food and Drug Administration (FDA) to validate ovarian cancer specimens pursuant to 510(k) approval of OvaDx(R), a pre-symptomatic ovarian cancer test that aids the monitoring of women diagnosed with ovarian cancer.'

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