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 support@ASPiRAlab.com

*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