Multigene Prognostic Tests in Breast Cancer
Multigene Prognostic Tests in Breast Cancer
In September 2013 the US Food and Drug Administration approved a second prognostic signature (Prosigna; Nanostring Technologies, Seattle, WA, USA) that also received clearance in the European Union. Prosigna is a diagnostic kit that uses Nanostring technology to quantify mRNA expression of 50 genes used in the PAM50 molecular classification algorithm and a series of housekeeping genes (that are used for normalization) as well as positive and negative controls in FFPE tissues to compute a risk of recurrence score. The risk of recurrence score reflects but does not explicitly report the intrinsic breast cancer subtype of the case.
The assay is approved to estimate distant recurrence-free survival for stage I/II (including one to three positive nodes), ER-positive breast cancer in postmenopausal women treated with adjuvant endocrine therapy. An appealing aspect of this test is that it can be performed by local pathology laboratories although it requires an expensive piece of equipment, the Nanostring nCounter Dx Analysis System (Nanostring Technologies).
PAM50/Risk of Recurrence/Prosigna Kit
In September 2013 the US Food and Drug Administration approved a second prognostic signature (Prosigna; Nanostring Technologies, Seattle, WA, USA) that also received clearance in the European Union. Prosigna is a diagnostic kit that uses Nanostring technology to quantify mRNA expression of 50 genes used in the PAM50 molecular classification algorithm and a series of housekeeping genes (that are used for normalization) as well as positive and negative controls in FFPE tissues to compute a risk of recurrence score. The risk of recurrence score reflects but does not explicitly report the intrinsic breast cancer subtype of the case.
The assay is approved to estimate distant recurrence-free survival for stage I/II (including one to three positive nodes), ER-positive breast cancer in postmenopausal women treated with adjuvant endocrine therapy. An appealing aspect of this test is that it can be performed by local pathology laboratories although it requires an expensive piece of equipment, the Nanostring nCounter Dx Analysis System (Nanostring Technologies).
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