The results demonstrate good performance of the PreciseDx Breast test on an independent low-risk early-stage cohort from the Netherlands. NPV of 0.96 (vs prior NPV of 0.94) with a sensitivity of 0.78 supports a potential role for enriching / triaging genomic assays and clinical models while guiding treatment / management decisions. Additional studies are underway to confirm these proposed clinical applications.
Third, CDK4/6i treatment is only incorporated in the recurrence costs but not in the first line of treatment for early-stage breast cancer due to limited data. Sensitivity analyses demonstrated robust overall savings to changes in all variables in the model. The use of PDxBr to assess breast cancer recurrence risk has the potential to fill gaps in care and reduce costs when gene expression signatures are not available.
4 months ago
HEOR • Journal
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Oncotype DX Breast Recurrence Score®Test • PreciseDx Breast Test
"COTA, PreciseDx and Baptist Health South Florida announced a collaboration to assess and validate the performance of the artificial intelligence (AI) -enabled PreciseBreast™ (PDxBr) test that predicts the likelihood of invasive breast cancer (IBC) recurrence."
The results from this observational study suggest that triaging patients with the PDxBr test could potentially be adjunctive to the management decision process of patients with early-stage IBC including the use and subsequent interpretation of genomic tests such as MammaPrint. Additional studies are underway to confirm these initial findings.
"PreciseDx®...announced a sponsored research collaboration with UCLA's Department of Pathology and Laboratory Medicine in Los Angeles to evaluate PreciseBreast's™ ability to accurately assess risk of recurrence for patients with triple-negative breast cancer (TNBC). TNBC constitutes only 10-20% of all breast cancer cases, yet continues to demand significant clinical interest due to its limited response to conventional treatments, the association with younger women, BRCA1/2 mutations, ethnic/racial disparities, and its highly aggressive characteristics."
"PreciseDx®...announced their attendance and participation at the 14th Annual European Breast Conference in Milan, Italy...is presenting the findings from the PreciseBreast™ biopsy clinical validation study through a poster presentation."
In summary, the analytical validation of the digital IBC risk assessment test demonstrated a strong performance across all features in the model and complimented the clinical validation of the assay previously shown to accurately predict recurrence within 6-years in early-stage invasive breast cancer patients.
"PreciseDx...announced that its analytical validation study for its PreciseBreast assessment has been published in the November 3, 2023 issue of Clinical Breast Cancer."
"PreciseDx...announced that the New York State Department of Health (NYSDOH) has approved the PDxBr, a Lab Developed Test (LDT) designed to enrich breast cancer grading and improve risk categorization. With this approval, PreciseDx can now begin commercially testing patient samples in the state of New York through its CLIA certified laboratory."
"PreciseDx...announced a sponsored research collaboration with the Breast Unit of the Champalimaud Clinical Center (CCC)/Champalimaud Foundation in Lisbon, Portugal...As part of the research collaboration, PreciseDx and the CCC will evaluate the performance of the PreciseDx Breast Assay in predicting breast cancer recurrence and treatment choice."