Multicenter, community based, clinical research studies completed.
Over 20 physicians and >500 patients
Sixteen poster and oral presentations
TME – Industry collaboration with independent data review, analysis and presentation
Title: InVitae Clinical Consult Services Evaluation Study
Summary: Genetic counselors are not uniformly available to all breast surgeons across the country. This study was designed to evaluate the value of remote genetic counseling services to breast surgeons prior to ordering for panel selection and after obtaining the results for help with interpretation.
Sites: 13 sites
Patient accrual: 249
Findings: Real time access to remote genetic counseling services changed test panel selection in 12% of patients. Post test remote access changed clinical management for patients and family in 15% of patients.
Poster Presentations 2017: Miami Breast Cancer Conference (1) , National Consortium of Breast Centers (1), American Society of Breast Surgeons (2)
Oral Presentation: National Consortium of Breast Centers March 12,2017 *Awarded Best Clinical Presentation
Journal Article: Submitted Annals of Surgical Oncology
Title: Paradigm NEo-Adjuvant Therapy Pilot Project
Summary: Genomic analysis of loco-regionally advanced breast cancers prior to neo-adjuvant systemic therapy. the study purpose was to correlate biomarkers to pathologic response.
Patient Accrual: 34
Findings: There was one Her2+ patient without a complete response and she had overexpression of IGFR (insulin growth factor receptor). The triple negative patients who did not have a complete pathological response had more mutations (greater mutational load) than the patients with a complete response. There were 2 luminal B patients with overexpression of mRNA for Her2/neu and they did not have a pathologic complete response.
Poster Presentations 2017: Miami Breast Cancer Conference
Title: Intact Medical IPEX Registry
Summary: Evaluate utilization of a minimally invasive large intact biopsy device for percutaneous excision of atypical lesions and small malignant tumors under image guidance outside of the operating room.
Sponsor: Intact Medical
Patient Accrual: 344
Findings: Atypical lesions and small malignant tumors can be effectively completely excised with a minimally invasive intact biopsy device without having to go to the operating room.
2017: American Society of Breast Surgeons (3)
2016: American Society of Breast Surgeons (2)
2015: San Antonio Breast Cancer Symposium (1)
2016: Society of Breast Imaging
2015: Australasian Breast Cancer Society
Title: Prelude DCIS Plus Decision Impact Study
Summary: Decision impact of Prelude DCISionRT test on selection of radiation for patients diagnosed with DCIS.
Patient Accrual: 100
Findings: The results of the DCISionRT test significantly impacted physician’s decision for radiation therapy.
Poster Presentations 2016: ASCO, Miami Breast Cancer Conference *Winner of Top Oncology Poster