IntroductionAdnexal or pelvic mass is a finding that commonly raises suspicion for malignancy, especially for ovarian cancer. Proper identification prior to surgery would permit appropriate referral to a specialty center in cases likely to be ovarian cancer, as optimal outcomes in such cases are obtained when surgical staging and treatment are provided at the time of initial surgery.MethodsWe compared the screening capabilities of two in vitro diagnostic multivariate index assays (IVDMIAs), a new IVDMIA (second-generation multivariate index assay: MIA2G) and a currently used triage algorithm (Risk of Ovarian Malignancy Assay: ROMA).ResultsAmong 245 subjects (24.7%) determined to have a malignancy, ROMA misclassified 51 malignancies (including 10 high-grade ovarian malignancies), whereas MIA2G misclassified 22 (including 5 high-grade ovarian malignancies). Early stage cancers were more frequently misclassified by ROMA (20 vs. 8 cases). The rate of “test-negative” malignancies was significantly higher for ROMA, while the rate of “test-positive” benign cases was significantly higher for MIA2G.ConclusionTriage algorithms play an important role in improving clinical outcomes for women presenting with an adnexal mass regardless of the eventual diagnosis. In this study, MIA2G was shown to correctly predict more cases of ovarian cancer than the ROMA algorithm.FundingAspira Labs/Vermillion Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-01010-8) contains supplementary material, which is available to authorized users.

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We characterize the clinical utility and economic benefits of a comprehensive pan-ethnic carrier screening panel that spans 282 monogenic disease conditions in a large, diverse population of 397,540 reproductive health patients. For 142,049 of these patients, we were able to accurately estimate genetic ancestries across 7 major population groups. We examined individual carrier and at-risk carrier couple (ARCC) rates with respect to self-reported and genetic ancestries across ancestry-specific and pan-ethnic panels. Our results show that this comprehensive panel identified >10-times the ARCCs compared with a two-gene pan-ethnic panel and provided a substantial benefit over ancestry-specific screening panels across the major population groups. Finally, we generated a universal cost-of-care model across the monogenic disease conditions represented on the comprehensive pan-ethnic carrier screening panel to demonstrate potential healthcare savings in addition to the demonstrated clinical benefits that could be realized adopting this type of panel as standard of care for all.

INTRODUCTION: This data set review examined rates of positive sexually transmitted disease (STD) results in women utilizing a consumer-initiated, self-collected STD kit over a twelve-month period. METHODS: De-identified data was obtained using SQL queries of EverlyWell's® database for women who took a Women's STD Panel Test from September 2017 through September 2018. A total of 1,003 tests were resulted from 951 unique women, 1 test was excluded for inadequate specimen, and 1,002 tests were analyzed in this study. Age range for this data set is 18 to 76. RESULTS: Overall, 21% of women received at least one positive STD result and 1.7% received more than one positive result. The most common STD resulted was Herpes Simplex Type 2 at 17% followed by Chlamydia trachomatis at 3.2%. The largest age group utilizing this platform for testing was 25 to 29 years, 23% of total tests taken. The highest proportion of positives within a single age group was found in 55 to 59 years, 54% of the total women in that group. CONCLUSION: In a single review of 1002 at-home STD panel test results, approximately 1 out of 5 women screened positive for at least one STD. At-home STD testing may allow women who would otherwise potentially be under-screened for a variety of reasons, such as age, to easily manage their sexual health testing. Self collected STD testing can easily be utilized by women of all ages to identify infections and seek care between routine gynecological visits.