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TEST:
PreciseDx Breast Test

Company:
PreciseDx
Type:
Laboratory Developed Test
Evidence

News

4ms
External validation of an AI-enabled digital test (PreciseDx Breast) to predict breast cancer recurrence within 6-years exhibited good independent performance on a comparable early-stage cohort from the Netherlands (ESMO 2024)
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.
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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PreciseDx Breast Test
4ms
U.S. payer budget impact of using an AI-augmented cancer risk discrimination digital histopathology platform to identify high-risk of recurrence in women with early-stage invasive breast cancer. (PubMed, J Med Econ)
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.
HEOR • Journal
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Oncotype DX Breast Recurrence Score®Test • PreciseDx Breast Test
6ms
COTA, Baptist Health South Florida, and PreciseDx announce collaboration on the ai-enabled breast cancer recurrence risk assessment, PreciseBreast™ (Businesswire)
"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."
Licensing / partnership
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PreciseDx Breast Test
7ms
AI-enabled digital test to predict disease recurrence for patients with early-stage invasive breast cancer and performance in a MammaPrint low-risk cohort from the Netherlands with a median 6-year follow-up. (ASCO 2024)
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.
Clinical
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HER-2 (Human epidermal growth factor receptor 2)
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MammaPrint • PreciseDx Breast Test
8ms
UCLA and PreciseDx announce new collaboration to advance AI-enabled predictions and risk mitigation for triple-negative breast cancer recurrence (PRNewswire)
"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."
Licensing / partnership
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PreciseDx Breast Test
8ms
PreciseDx presents new research on their AI-enabled digital test at 14th Annual European Breast Conference (PRWeb)
"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."
Clinical data
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PreciseDx Breast Test
11ms
PreciseDx collaborates with Baylor Scott & White Health to validate PreciseBreast assessment for early-stage invasive breast cancer detection (PreciseDx Press Release)
"PreciseDx...collaborating with Baylor Scott & White Health in Texas to validate its PreciseBreast assessment for early-stage invasive breast cancer."
Licensing / partnership
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PreciseDx Breast Test
11ms
Analytical Validation of the PreciseDx Digital Prognostic Breast Cancer Test in Early-Stage Breast Cancer. (PubMed, Clin Breast Cancer)
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.
Journal
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PreciseDx Breast Test
1year
PreciseDx's analytical validation of a digital breast cancer test predicting recurrence in early-stage breast cancer featured in Clinical Breast Cancer (PRNewswire)
"PreciseDx...announced that its analytical validation study for its PreciseBreast assessment has been published in the November 3, 2023 issue of Clinical Breast Cancer."
Clinical data
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PreciseDx Breast Test
almost2years
PreciseDx receives New York state approval for an AI-enabled breast diagnostic (PRNewswire)
"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."
Regulatory • Clinical
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PreciseDx Breast Test
almost2years
PreciseDx to collaborate with the Champalimaud Foundation to enhance current approaches of breast cancer risk assessment (PreciseDx Press Release)
"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."
Licensing / partnership
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PreciseDx Breast Test