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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENOMIC HEALTH ONCOTYPE DX TEST FOR BREAST CANCER PATIENTS

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GENOMIC HEALTH ONCOTYPE DX TEST FOR BREAST CANCER PATIENTS Back to Search Results
Event Date 01/01/2008
Event Type  Malfunction  
Event Description

The oncotype dx test (b)(6) has grossly inaccurate results for the her2 gene by qrt-pcr. The sensitivity for a positive result is only 31%. I discovered this as a qa exercise in my hospital lab. I am the chief of pathology at (b)(6) hospital of (b)(6). This is a vital urgent, pt safety issue. The oncotype dx test is ordered by oncologists for breast cancer pts. The test is supposed to tell the risk of recurrence for breast cancer and whether the pt should be advised to have chemotherapy or not, based on the "recurrence score" that the test reports. The recurrence score range is from 0-100 and is based on a multiplex test that tests the quantity of 16 genes, including the her2 gene. The her2 gene is a special component of the test, because pts who are positive for her2 are supposed to receive a special "targeted therapy" unique for their disease. We have found that the her2 gene has a false negative rate of 69%, which means that pts who are supposed to receive the special targeted therapy may not receive it, and the recurrence score will be erroneous because of the erroneous her2 result. Another serious concern is that, if this test is missing 69% of positive results for her2, what else is it missing? is the test reliable and robust? this test appears to have systemic problems and needs to being thoroughly examined by an independent entity. The test is bound to cause serious pt harm by using inappropriate therapies for breast cancer pts. This test is available worldwide, not just in the us. I hold the test records for each of these pts.

 
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Brand NameONCOTYPE DX TEST FOR BREAST CANCER PATIENTS
Type of DeviceONCOTYPE DX
Manufacturer (Section D)
GENOMIC HEALTH
redwood city CA
MDR Report Key1916837
Report NumberMW5018398
Device Sequence Number1
Product CodeOQS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 11/29/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 11/28/2010 Patient Sequence Number: 1
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