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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFoundationFocus CDxBRCA
Classification Namenext generation sequencing oncology panel, somatic or germline variant detection system
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
FOUNDATION MEDICINE, INC
150 second street, 1st floor
cambridge, MA 02141
PMA NumberP160018
Date Received06/30/2016
Decision Date12/19/2016
Product Code
PQP[ Registered Establishments with PQP ]
Docket Number 16M-4459
Notice Date 01/12/2017
Advisory Committee Pathology
Clinical Trials NCT01482715
NCT01891344
NCT02042378
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for The FoundationFocus CDxBRCA is a next generation sequencing based in vitro diagnostic device for qualitative detection of BRCA1 and BRCA2 alterations in formalin-fixed paraffin-embedded (FFPE) ovarian tumor tissue. The FoundationFocus CDxBRCA assay detects sequence alterations in BRCA1 and BRCA2 (BRCA1/2) genes. Results of the assay are used as an aid in identifying ovarian cancer patients for whom treatment with Rubraca (rucaparib) is being considered. If a patient is positive for any of the deleterious alterations specified in the BRCA1/2 classification, the patient may be eligible for treatment with Rubraca. This assay is to be performed at Foundation Medicine, Inc., a single laboratory site located at 150 Second Street, Cambridge, Massachusetts.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 
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