Improving Standard of Care

ImprovStdofCare

Improving Standard of Care

When evaluating an ovarian mass, ACOG/SGO have approved specific guidelines to assist in the appropriate referral of women to a Gynecologic Oncologist.

ACOG/SGO REFERRAL GUIDELINES	MODIFIED GUIDELINES
PREMENOPAUSAL	PREMENOPAUSAL
CA125 > 200 U/mL Ascites Evidence of abdominal or distant metastatis Family history of breast or ovarian cancer	CA125 > 67 U/mL Ascites Evidence of abdominal or distant metastasis Family history of breast or ovarian cancer
POSTMENOPAUSAL	POSTMENOPAUSAL
CA125 > 35 U/mL Ascites Nodular or fixed pelvic mass Evidence of abdominal or distant metastatis Family history of breast or ovarian cancer	CA125 > 35 U/mL Ascites Evidence of abdominal or distant metastasis Family history of breast or ovarian cancer

As part of the OVA1 clinical trial, a physician's pre-surgical clinical impression included a combination of transvaginal ultrasound, pelvic exam, CA125, CT scan or either the original guidelines or modified guidelines. The data from collected in the clinical trial from evaluations by non-gynecologic oncologists are noted in the table below. Sensitivity based on the original guidelines was 77.0% and improved to 80.0% with the modified guidelines. NPV was 87.0% and 88.0%, respectively. When added to the physicians Clinical Impression, OVA1 improved Sensitivity from 72.2% to 91.7% and NPV from 89.1% to 93.2%, respectively. When evaluating all subjects (n=516), overall Sensitivity and NPV improved to 95.7% and 94.6%, respectively. Overall data included patients evaluated by either gynecologic oncologists and/or non-gynecologic oncologists.

OVA1 vs. Available Tools¹

	Sensitivity	NPV
Clinical Impression (CI)	72.2%	89.1%
CA125-II	68.9%	85.9%
ACOG/SGO guidelines	77.0%	87.0%
Modified ACOG/SGO guidelines	80.0%	88.0%
Dual Impression (CI with OVA1)	91.7%	93.2%

When compared to the physician's Clinical Impression (CI), CA125-II and referral guidelines, OVA1 significantly improved clinical sensitivity while increased NPV strengthened the predication that cancer was absent.

How is OVA1 different than CA125?

OVA1 is the only blood test cleared by the FDA for pre-surgical evaluation of a woman with an ovarian mass. CA125 is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Moreover, CA125 is one of the five biomarkers included in the OVA1 panel.

OVA1 Demonstrates High Sensitivity²

Data from the OVA1 clinical trial provides a performance comparison of Dual Impression (CI with OVA1) to CA125-II:

Subjects	OVA1	CA125-II
All cancers (n=161)	92.5%	68.9%
All epithelial ovarian cancer (EOC; n=96)	99.0%	82.3%
Early state EOC (n=41)	97.6%	65.9%
Pre-menopausal women with early stage EOC (n=14)	92.9%	35.7%

Overall, OVA1 detected 76% of malignancies missed by CA125-II in the OVA1 clinical trial, including all advanced stage malignancies. Because of the high mortality from ovarian cancer, clinical sensitivity for malignancy is paramount. (Full Abstract)

¹ OVA1 Product Insert
² Ueland, et al., 13th Annual International Gynecologic Cancer Society meeting (October, 2010, Prague)