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November 28, 2012
10:45 EDTVRMLGO publishes new study showing positive performance of Vermillion test
Gynecologic Oncology has published the second prospective clinical study of OVA1 which demonstrated the positive performance of the multi-biomarker test in the triage of early-stage ovarian cancer. Vermillion, the molecular diagnostics company which developed and currently markets the test, had reported positive top-line results of the study in July. Referred to as "OVA500," the study confirms and extends the findings of the first OVA1 pivotal study published last year in Obstetrics & Gynecology by Dr. Fred Ueland of the University of Kentucky. The multi-center study investigated OVA1 performance in the pre-surgical detection of malignancy among 494 women prospectively enrolled from non-gynecologic oncology practices. Sensitivity across all types of ovarian cancers was 96% when OVA1 was added to routine clinical assessment, and this result was nearly identical to the first pivotal study. Importantly, within the test group OVA1 identified 83% of cancers missed by clinical assessment and 71% of cancers missed by CA125.
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March 27, 2015
08:06 EDTVRMLVermillion announces initial results from OVA1 clinical trial
Vermillion announced initial results from a cost-effectiveness analysis study, co-authored by Dr. Robert Bristow and Dr. Gareth Forde, clinicians at the UC Irvine and Dr. John Hornberger, a health economist at Stanford University School of Medicine. The analysis reported by Dr. Forde and his colleagues differed from previous studies in that it: Utilized OVA1 test performance characteristics derived directly from two OVA1 clinical trials; Compared cost-effectiveness using only common, validated benchmark protocols and cutoffs; Evaluated a single prospectively enrolled and double-blinded registry study cohort for which each benchmark method was compared on a per-patient basis with OVA1 results; Included an expert treatment decision path analysis, independently published epidemiology and quality of life utility assumptions and a robust hidden Markov model methodology; Considered direct costs from a Medicare reimbursement perspective, and separately, inclusion of indirect costs associated with lost patient and caregiver productivity.
March 17, 2015
19:42 EDTVRMLOn The Fly: After Hours Movers
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16:45 EDTVRMLVermillion announces new agreement with Quest Diagnostics
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