PURPOSE: Germline testing for men with prostate cancer (PCa) poses numerous implementation barriers. Alternative models of care delivery are emerging, but implementation outcomes are understudied. We evaluated implementation outcomes of a hybrid oncologist– and genetic counselor–delivered model called the genetic testing station (GTS) created to streamline testing and increase access. METHODS: A prospective, single-institution, cohort study of men with PCa referred to the GTS from October 14, 2019, to October 14, 2021, was conducted. Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, we described patients referred to GTS (Reach), the association of GTS with germline testing completion rates within 60 days of a new oncology appointment in a pre- versus post-GTS multivariable logistic regression (Effectiveness), Adoption, Implementation, and Maintenance. Because GTS transitioned from an on-site to remote service during the COVID-19 pandemic, we also compared outcomes for embedded versus remote GTS. RESULTS: Overall, 713 patients were referred to and eligible for GTS, and 592 (83%) patients completed germline testing. Seventy-six (13%) patients had ≥ 1 pathogenic variant. Post-GTS was independently associated with higher odds of completing testing within 60 days than pre-GTS (odds ratio, 8.97; 95% CI, 2.71 to 29.75; P < .001). Black race was independently associated with lower odds of testing completion compared with White race (odds ratio, 0.35; 95% CI, 0.13 to 0.96; P = .042). There was no difference in test completion rates or patient-reported decisional conflict for embedded versus remote GTS. GTS has been adopted by 31 oncology providers across four clinics, and implementation fidelity was high with low patient loss to follow-up, but staffing costs are a sustainability concern. CONCLUSION: GTS is a feasible, effective model for high-volume germline testing in men with PCa, both in person and using telehealth. GTS does not eliminate racial disparities in germline testing access.

Introduction: Breast cancer (BC) is one of the most common cancers globally. Genetic testing can facilitate screening and risk-reducing recommendations, and inform use of targeted treatments. However, genes included in testing panels are from studies of European-ancestry participants. We sequenced Hispanic/Latina (H/L) women to identify BC susceptibility genes.Methods: We conducted a pooled BC case-control analysis in H/L women from the San Francisco Bay area, Los Angeles County, and Mexico (4,178 cases and 4,344 controls). Whole exome sequencing was conducted on 1,043 cases and 1,188 controls and a targeted 857-gene panel on the remaining samples. Using ancestry-adjusted SKAT-O analyses, we tested the association of loss of function (LoF) variants with overall, estrogen receptor (ER)-positive, and ER-negative BC risk. We calculated odds ratios (OR) for BC using ancestry-adjusted logistic regression models. We also tested the association of single variants with BC risk.Results: We saw a strong association of LoF variants inFANCMwith ER-negative BC (p=4.1×10-7, OR [CI]: 6.7 [2.9-15.6]) and a nominal association with overall BC risk. Among known susceptibility genes,BRCA1(p=2.3×10-10, OR [CI]: 24.9 [6.1-102.5]),BRCA2(p=8.4×10-10, OR [CI]: 7.0 [3.5-14.0]), andPALB2(p=1.8×10-8, OR [CI]: 6.5 [3.2-13.1]) were strongly associated with BC. There were nominally significant associations with CHEK2, RAD51D, and TP53.Conclusion: In H/L women, LoF variants inFANCMwere strongly associated with ER-negative breast cancer risk. It previously was proposed as a possible susceptibility gene for ER-negative BC, but is not routinely tested in clinical practice. Our results demonstrate thatFANCMshould be added to BC gene panels.

112 Background: A remote Genetic Testing Station (GTS) workflow was implemented at an academic medical institution to expand access to genetic testing for patients with prostate cancer. During a telephone appointment, a genetic counselor assistant collects family history and facilitates genetics education, research consent, and remote sample collection for multi-gene panel testing. We compared testing completion and patient loss from workflow based on race/ethnicity and preferred language to identify disparities. Methods: Metrics were collected prospectively and analyzed retrospectively for patients with metastatic or high-grade prostate cancer referred to genetics between 3/15/2020 – 6/30/2022. Self-reported race, ethnicity, and preferred language were collected by chart review. Testing completion was compared between groups using Fisher’s exact test, with White non-Hispanic (WNH) and Preferred Language English (PLE) cohorts as controls. Odds ratios and 95% confidence intervals were reported. Patient loss at workflow checkpoints (scheduling, consenting, sample collection, and results release) was summarized for each group. Results: 827 eligible patients were identified: 78 (9%) Asian /Pacific Islander (API), 51 (6%) Black non-Hispanic (BNH), 42 (5%) Hispanic, and 625 (76%) WNH. 31 patients reporting other non-Hispanic race were not included in the analysis. 30 patients (4%) self-reported Preferred Language non-English (PLNE) and 797 (96%) PLE. BNH patients were significantly less likely to complete testing compared to WNH patients (OR 0.320, 95%CI: 0.168, 0.632, p<0.001). There was no difference in testing completion in API (OR 0.918, 95%CI: 0.467, 1.944, p=0.797) or Hispanic (OR 0.743, 95%CI: 0.325, 1.918, p=0.466) compared to WNH patients. PLNE were significantly less likely to complete testing (OR 0.393, 95%CI: 0.171, 0.965, p=0.016) compared to PLE patients. Patient loss occurred primarily at consenting and sample collection. 14% of BNH, and 9% of Hispanic patients did not consent, compared to 4% of WNH. 17% of PLNE did not consent compared to 5% of PLE patients. 13% of BNH did not return a sample, compared to 3% of WNH patients. Conclusions: In remote GTS, BNH and PLNE patients were significantly less likely to complete germline testing than WNH and PLE patients respectively. Disparities in patient loss were most pronounced at consenting and sample collection. Measures to mitigate disparities include assisted consenting (with interpreter as needed) and video-assisted or in-clinic sample collection. [Table: see text]

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