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12:00 AM, Mar 09, 2015  |  BC Week In Review | Clinical News  |  Regulatory

MammaPrint FFPE regulatory update

FDA granted 510(k) clearance to Agendia’s MammaPrint FFPE test to predict the risk of breast cancer …
a 70-gene signature chip to predict recurrence regardless of patient age or HER2 receptor status. Agendia
markets MammaPrint Fresh for fresh tumor tissue. Agendia N.V. , Amsterdam, the Netherlands   Product: MammaPrint …
12:00 AM, Oct 07, 2013  |  BC Week In Review | Clinical News  |  Regulatory

Oncotype DX breast cancer assay regulatory update

Agendia B.V. , Amsterdam, the Netherlands   Genomic Health Inc. (NASDAQ:GHDX), Redwood City, Calif.   General …
diagnostics, which NICE continues to recommend for use only in the research setting: MammaPrint from Agendia
12:00 AM, Sep 16, 2013  |  BC Week In Review | Clinical News  |  Regulatory

MammaPrint regulatory update

Agendia said updated clinical practice guidelines published in the Annals of Oncology confirmed that its MammaPrint …
Oncology (JSMO) and the St. Gallen International Breast Cancer Conference Expert Panel provided the guidelines. Agendia
used where available to determine the individual recurrence risk and predict the benefit from chemotherapy. Agendia
12:00 AM, Feb 25, 2013  |  BC Week In Review | Clinical News  |  Regulatory

IHC immunohistochemistry assay regulatory update

the most plausible ICER per QALY for Oncotype DX was likely to exceed £91,300 ($144,509). Agendia
diagnostics, which NICE continues to recommend for use only in the research setting: MammaPrint from Agendia
12:00 AM, Feb 06, 2012  |  BC Week In Review | Clinical News  |  Regulatory

IHC immunohistochemistry assay regulatory update

said is associated with increased bias compared to prospective trials. The tests are MammaPrint from Agendia
£26,598 ($41,687), respectively, compared with current practice. Comments on the draft are due Feb. 24. Agendia
12:00 AM, Dec 21, 2009  |  BC Week In Review | Clinical News  |  Regulatory

Mammaprint regulatory update

Agendia received market clearance from FDA to expand use of its MammaPrint multi-gene expression test to …
of all ages. The in vitro diagnostic multivariate index assay (IVDMIA), which is conducted in Agendia's …
CLIA-certified laboratory, also has CE Mark approval in the EU. Agendia B.V. , Amsterdam, the Netherlands …
12:00 AM, Jun 29, 2009  |  BC Week In Review | Clinical News  |  Regulatory

MammaPrint regulatory update

Agendia B.V. , Amsterdam, the Netherlands   Product: MammaPrint   Business: Diagnostic   Recommendations from an …
multi-gene assays include: MammaPrint, a breast cancer prognostic test using a 70-gene signature chip from Agendia
12:00 AM, Jun 29, 2009  |  BC Week In Review | Clinical News  |  Regulatory

Oncotype DX breast cancer assay regulatory update

assays include: MammaPrint , a breast cancer prognostic test using a 70-gene signature chip from Agendia
12:00 AM, Jun 01, 2009  |  BC Week In Review | Clinical News  |  Regulatory

Agendia, Genentech, Roche regulatory update

Agendia submitted a letter to FDA in support of a Citizen's Petition in which Roche's Genentech …
to tests than would be possible under the FDA approval process (see BioCentury, March 2). Agendia's …
Europe and 510(k) clearance in the U.S. to predict the likelihood of breast cancer recurrence. Agendia
12:00 AM, Jan 26, 2009  |  BC Week In Review | Clinical News  |  Regulatory

MammaPrint regulatory update

provide clinical validation for the ability of Oncotype DX from Genomic Health and MammaPrint from Agendia
Centers for Disease Control and Prevention (CDC), but its recommendations are not official government policy. Agendia

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