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IVD Developer Vermillion Opens CLIA Lab

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Vermillion, developer of the 510(k)-cleared OVA1 test, has recently opened its own CLIA lab, called ASPiRA Labs (source: company press release). The lab will initially focus on providing the OVA1 test, but will eventually “expand to other gynecologic conditions with high unmet need.” Did Vermillion learn some hard lessons from getting clearance of OVA1 that they would like to avoid for future tests? I think I would be surprised if the next tests out of Vermillion’s pipeline were not LDTs.