Biomedical Engineering Reference
In-Depth Information
14.4
Analytic Development for MammaPrint as
a Diagnostic Test
All MammaPrint tests are performed using a customized microarray
in the Agendia's Clinical Laboratory Improvement Amendments
(CLIA)-accredited service laboratories at the company's
headquarters in Amsterdam, the Netherlands since 2004 and in
Irvine, California since 2008. In February 2007, it became the first
in
vitro
diagnostic multivariate index assay cleared by the US Food and
Drug Administration (FDA) to assess the risk of tumor recurrence in
lymph node negative breast cancer patients under 61 years of age
with tumors or less than 5 cm, who were within 10 years of diagnosis.
FDA clearance under the
diagnostic multivariate index assay
(IVDMIA) guidelines requires clinical and analytical validation and
reporting systems to ensure patient safety issues are addressed.
The FDA label indicates that as a diagnostic tool, MammaPrint has
a 98.9% degree of accuracy in classifying patients as Low Risk or
High Risk and technical reproducibility of 98.5%. It is recommended
that MammaPrint
in vitro
results are used by physicians as a prognostic
marker only, along with other clinicopathological factors in planning
treatment with adjuvant chemotherapy.
Since its initial FDA clearance, several modifications of the
cleared device have been made such as changing the specimen type
from fresh frozen tissue to fresh tissue stored in a specific RNA
preservative solution (i.e., RNARetain room temperature tissue
fixative) and XPrint software v1.33 to v1.40. Recently, the FDA
cleared the MammaPrint test for breast cancer recurrence in all ages
and all stage I and II breast cancer patients, including patients with
negative and up to three positive lymph nodes. Agendia received its
fifth FDA clearance for MammaPrint in early 2011 to allow the test
to be performed using two additional Agilent Microarray scanners
and two Agilent Bioanalyzers in CLIA- and College of American
Pathologists (CAP)-accredited central laboratories in Amsterdam,
the Netherlands. With this approval, Agendia could provide a
consistent testing service in case one machine is down and could
accommodate the increasing need for clinical testing.
It is currently covered by Centers for Medicare and Medicaid
Services and most major insurance carriers in the US. In Europe,
MammaPrint has been approved for all ages since 2004. The cost of
the assay in the US is $4,200. In Europe, the test costs EUR 2675. Some
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