Testing Core Biopsy Specimens
The COVID-19 pandemic has had a life-altering effect on the lives of the general population, but most notably health care providers and those with a diagnosis of cancer. We are all aware that in order to optimize provider, hospital, and clinic delivery of care, decisions are being made that are resulting in the postponement of both screening and diagnostic oncology services as well as elective surgery.
Our Oncotype DX® tests remain readily available and our laboratory continues to operate.
Core biopsies are the initial diagnostic procedure of choice for breast masses identified by physical exam or by imaging techniques.
The Oncotype DX test process was optimized to require only small amounts of tumor tissue and can be performed on a core biopsy of the breast cancer in lieu of the final resection specimen.
If you have any questions about the testing of a core biopsy specimen or general questions on Oncotype
DX tests, you can continue to reach out to your local representative or medical science liaison (MSL) or
call Customer Service at
866-ONCOTYPE (
866-662-6897)
Approximately 20% of all new breast cancers diagnosed in the United States are ductal carcinoma in situ (DCIS)1, but no two DCIS patients—or their tumors—are the same.
It is estimated that by 2020, more than one million women
in the United States will be living with a DCIS diagnosis, up from 500,000 in 20051
The Oncotype DX Breast DCIS Score test is the first
clinically-validated, commercially available genomic test for patients with DCIS. It looks at the unique biology of a patient’s tumor—so you can better personalize the treatment plan for each patient’s unique situation.
the first and only clinically-validated, commercially available genomic test for patients with DCIS
An individualized assessment of risk
Generally DCIS is a non-lethal form of breast cancer, but treatments—such as surgery, radiation therapy, and hormonal therapy—can be relatively aggressive. The key to choosing the right treatment options is assessing the patient’s risk for a local recurrence (DCIS or invasive carcinoma). Often, this assessment is based only on clinical and pathologic factors or nomograms (standardized guidelines that rely on population-based estimates of average risk).
The Breast DCIS Score test provides an individualized assessment for the risk of local recurrence. Performed on a tumor sample after a biopsy or surgery, the test looks at 12 cancer-related genes in your patient’s tumor—giving you information that clinical and pathologic factors alone can’t provide. In fact, the test shows that patients with similar clinical and pathologic features do not necessarily have the same local recurrence risk.2-4
The Breast DCIS Score test results include2-4:
- An individualized prediction of the 10-year risk of any local recurrence (DCIS or invasive carcinoma) or an invasive local recurrence.
- An established baseline for consideration of absolute benefit from radiation therapy (XRT).
- Quantitative ER and PR single gene expression values.
- A patient-friendly summary page to help explain the results to your patients
EXAMPLE
Case Study Comparison - Clinical use of the DCIS Score result
|
| 63-year-old patient |
66-year-old patient |
Menopausal Status: Postmenopausal
Tumor Type: DCIS
Tumor Size: 1.6 cm
ER Status (IHC): Positive
Nuclear Grade: 2
Comedo Necrosis: Absent
Margin Width: 2 mm
|
Menopausal Status: Postmenopausal
Tumor Type: DCIS
Tumor Size: 1.0 cm
ER Status (IHC): Positive
Nuclear Grade: 2
Comedo Necrosis: Absent
Margin Width: 2 mm
|
DCIS Score result:
3
|
DCIS Score result:
57
|
| 10% risk of any local recurrence (DCIS or invasive)
|
23% risk of any local recurrence (DCIS or invasive)
|
| 3% risk of an invasive local recurrence
|
13% risk of an invasive local recurrence
|
| Cases submitted by Charles Leonard, MD, from Rocky Mountain Cancer Centers. |
Results your patients can relate to
The Breast DCIS Score report includes the “DCIS Score result”, which is a number between 0-100.
- Patients with a low risk estimate are likely to have a smaller absolute benefit from radiation therapy.
- Patients with a high risk estimate are likely to have a greater absolute benefit from radiation therapy.
This numeric score makes it easy for patients to understand their level of risk. As a result, discussing treatment options with your patients is easier and more efficient, and patients feel more confident about their decisions.
Evidence it works
Two validation studies—ECOG E5194 and the Ontario DCIS Cohort—confirm that the DCIS Score result predicts the 10-year risk of local recurrence.2-4 In addition, studies show that physicians regularly change treatment recommendations based on the test results.5,6