Ovarian Cancer Survival has Not Changed In 40...
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Ovarian Cancer Survival has Not Changed In 40 Years FOR MASSES THAT ARE HIGHLY SUSPICIOUS FOR OVARIAN CANCER, REFERRAL TO A GYNECOLOGICAL ONCOLOGIST IS ADVISED 1 • FDA-cleared blood test that helps assess malignancy risk in adnexal masses planned for surgery • The OvaCalc ® algorithm generates single risk score based on menopausal status, CA-125, and four host response biomarkers • Highly sensitive method of assessment for malignancy in adnexal masses OVA1 ® – Your Clear Pathway Earlier Detection Could Make The Difference OVA1 Provides Confidence in Your Treatment Decisions With a Negative Predictive Value of 98%, OVA1 may help you:Tumor Behavior with Host Response by 1. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee Opinion No. 477: the role of the obstetri- cian-gynecologist in the early detection of epithelial ovarian cancer. Obstet Gynecol 2011; 117:742. 2. Bristow RE, Smith A, Zhang Z, et al., Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol Oncol. 2013;128:252-259. • Reduce repeat imaging studies • Limit the need for frozen sections during surgery • Minimize the cases in which you have a Gyn Onc on standby • Save patients the time and expense of traveling to a cancer center Confidence in Managing Patients with Negative Results Negative Predictive Value 2 98% Bristow et al., 2013 n = 494 Confidence Intervals: 95.2-99.2 Protein DOWN Apolipoprotein A1 Cholesterol Transport UP Beta 2 microgloblin Host immune response UP CA-125II Released by tumor cells DOWN Prealbumin Hormone and vitamin transport DOWN Transferrin Iron transport Function
Transcript of Ovarian Cancer Survival has Not Changed In 40...
Ovarian Cancer Survival has Not Changed In 40 Years
FOR MASSES THAT ARE HIGHLY SUSPICIOUS FOR OVARIAN CANCER, REFERRAL TO A GYNECOLOGICAL ONCOLOGIST IS ADVISED1
• FDA-cleared blood test that helps assess malignancy risk in adnexal masses planned for surgery
• The OvaCalc® algorithm generates single risk score based on menopausal status, CA-125, and four host response biomarkers
• Highly sensitive method of assessment for malignancy in adnexal masses
OVA1® – Your Clear Pathway
Earlier Detection Could Make The Difference
OVA1 Provides Confidence in Your Treatment Decisions
With a Negative Predictive Value of 98%, OVA1 may help you:Tumor Behavior with Host Response
by
1. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee Opinion No. 477: the role of the obstetri-cian-gynecologist in the early detection of epithelial ovarian cancer. Obstet Gynecol 2011; 117:742. 2. Bristow RE, Smith A, Zhang Z, et al., Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol Oncol. 2013;128:252-259.
• Reduce repeat imaging studies
• Limit the need for frozen sections during surgery
• Minimize the cases in which you have a Gyn Onc on standby
• Save patients the time and expense of traveling to a cancer center
Confidence in Managing Patients with Negative ResultsNegative Predictive Value2
98%Bristow et al., 2013n = 494Confidence Intervals: 95.2-99.2
Protein
DOWN
ApolipoproteinA1
CholesterolTransport
UP
Beta 2microgloblin
Host immune response
UP
CA-125II
Released by tumor cells
DOWN
Prealbumin
Hormone and vitamin transport
DOWN
Transferrin
Iron transportFunction
OVA-1.com | ASPiRAlab.com(844) ASPiRA1 / (844) 277.4721 or [email protected]
*Risk stratification by each test using cut-offs specified by FDA intended use
1. Bristow RE, Smith A, Zhang Z, et al., Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol Oncol. 2013;128:252-259. 2. Ueland FR, et al., Effectiveness of a multivariate index assay in the preoperative assessment of ovarian tumors. Obstet Gynecol 2011;117:1289-1297. 3. Miller R. et al., Performance of the American College of Obstetricians and Gynecologists’ Ovarian Tumor Referral Guidelines With a Multivariate Index Assay. Obstet Gynecol 2011;117(6):1298-1306. 4. Grenache DG, et al., Clinical performance of two multi-marker blood tests for predicting malignancy in women with an adnexal mass. Clin Chim Acta. 2015 Jan 1;438:358-63. doi: 10.1016/j.cca.2014.09.028.
Sensitivity by Stage1
Stage I Stage II Early Stage Pre-menopausal Early Stage
Post-menopausal Early Stage
CA-125II* 64% 71% 66% 46% 75%
OVA1** 89% 100% 91% 91% 92%
Increase Sensitivity for Malignancy in the Care Pathway You Direct
Sensitivity1,2,3
OPTIONS:
OVA1**
CA-125II*
Modified ACOG guidelines
Clinical assessment
OVA1 with clinical assessment
92%
69%
80%
75%
96%
8%
31%
20%
25%
4%
Rate of Cancer MissedRate of Cancer Detected
by
Adnexal masses
planned for surgery
Benign
Malignant
Ob/Gyn: Treat
Gyn Onc: Consult or Refer
MinimizeUncertainty
PATIENT
98% NPV
+ clinical assessm
ent
4*
ROMA60
100
Sensitivity (%)
Pre-menopausal Post-menopausal Combined
8996
84
97
n = 146
