OvaSure™ For Women at High-Risk for Ovarian Cancer
OvaSure™ For Women at High-Risk for Ovarian Cancer | | | |
| Number | | 004245 |
| CPT | | 82985; 83520 (x2); 84146; 84305; 86304 |
| Related Information | | Cancer Antigen (CA) 125, Serum
(002303) |
| Synonyms | | OvaSure™, Yale Ovarian Cancer Test |
| Test Includes | | Leptin, prolactin, osteopontin, insulin-like growth factor
II, macrophage inhibitory factor, CA-125, and a calculated
risk index. |
| Special Instructions | | For more information, please contact LabCorp's
OvaSure™ physician support line at 888-248-0123. To
authorize serial monitoring, please order test 481245. |
| Specimen | | Serum, frozen |
| Volume | | 1.0 mL |
| Minimum Volume | | 0.3 mL (Note:This volume does not allow for
repeat testing.) |
| Container | | Red-stopper tube without gel barrier |
| Collection | | Separate serum from cells and transfer to a plastic
transport tube. |
| Storage Instructions | | Freeze |
| Causes for Rejection | | Non-serum sample received; serum sample drawn in
gel-barrier tube; nonfrozen sample received |
| Use | | The OvaSure™ assay may be used as a tool to identify
high-risk women who might have ovarian carcinoma.
OvaSure™ is not indicated for a patient who is
currently undergoing chemotherapy, who has had both ovaries
removed, who is pregnant, or who is lactating. |
| Limitations | | Pregnant women or women who are lactating should not be
screened by the assay because it may lead to false-positive
results. About 10% of women with benign ovarian masses
(including cysts) may have positive results by this test. A
calculated risk Index of 0.50 or greater indicates a
positive reading, which is suggestive of ovarian cancer
(possible presence of disease). In a clinical study across
all disease stages, the six-marker panel composed of
leptin, prolactin, osteopontin, insulin-like growth factor
II, macrophage inhibitory factor, and CA-125 demonstrated a
sensitivity of 95.3% and a specificity of 99.4% in
detecting disease.1
Greater than 99% sensitivity (119 of 120) was shown in
late-stage disease (stage III and stage
IV).1 In early stage
disease (stage I and stage II), the assay demonstrated a
sensitivity of 91.6%, providing a significant improvement
over CA-125 alone (less than 60% of stage I and stage II
combined) for ovarian cancer
detection.1 All positive
readings should be retested on a new sample drawn at least
three weeks after the original sample was collected.
Patients with positive results confirmed by retesting on a
second sample should be followed by a women's health
specialist who may order additional evaluations, such as
sensitive imaging.
Components used in this test are labeled as research
purposes only. The performance characteristics of this
product have not been established by the assay
manufacturer. Results should not be used as a diagnosis for
ovarian cancer without confirmation of the diagnosis by
another medically established diagnostic product or
procedure. |
| Methodology | | Multiplex, bead-based immunoassay |
| Additional Information | | Ovarian cancer is the eighth most common cancer in women
and and the fifth leading cause of cancer-related deaths in
women in the US. The American Cancer Society estimates that
approximately 21,650 women will be diagnosed with ovarian
cancer in 2008. It is estimated that 15,520 women will die
from this disease in 2008. Despite ovarian cancer being
about one eighth as common as breast cancer, the
five-year and 10-year survival rates for breast cancer are
twice as high as survival rates for ovarian
cancer.2
Ovarian cancer causes more deaths than any other
reproductive system cancer. There are typically few
patient-recognized symptoms; most cases are detected with
regional or distant disease, and historically there has
been no effective screening test. Consequently, ovarian
cancer is most frequently detected only after metastasis
has occured.1 The death
rate for this disease has not changed significantly in the
last 50 years.2
In the general population, approximately 81% of women with
invasive ovarian cancer are not diagnosed until the disease
has reached an advanced stage, ie, until it has spread to
the upper abdomen (regional) or beyond (distant).
Unfortunately, only 19% of ovarian carcinomas are found at
an early, or localized, stage. Although the overall
relative five-year survival rate for all ages of onset and
for all stages of ovarian cancer is 45%, the five-year
survival rate for women with distant ovarian cancer is
approximately 30%. By contrast, the five-year survival rate
for localized ovarian cancer is 92% and for regional
ovarian cancer is 71%.2 |
| Footnotes | |
- Visintin I, Feng Z, Longton G, et al.
Diagnostic markers for early detection of ovarian cancer.
Clin Cancer Res. 2008 Feb 15;14(4):1065-1072.
- American Cancer Society. Cancer Facts &
Figures 2008. Atlanta Ga. American Cancer Society,
2008.
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