| 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. |
| |
| Device | FoundationFocus CDxBRCA |
|---|
| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
|---|
| Applicant | FOUNDATION MEDICINE, INC
150 Second Street, 1st Floor
Cambridge, MA 02141 |
|---|
| PMA Number | P160018 |
|---|
| Date Received | 06/30/2016 |
|---|
| Decision Date | 12/19/2016 |
|---|
| Product Code |
PQP |
| Docket Number | 16M-4459 |
|---|
| Notice Date | 01/12/2017 |
|---|
| Advisory Committee |
Pathology |
|---|
| Clinical Trials | NCT01482715
|
|---|
| 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 |
|
|
