Clinical Studies and Research
OVA1 (MIA) was rigorously validated to determine its effectiveness for evaluating the risk of ovarian cancer prior to surgery. The various clinical studies have shown that OVA1 (MIA) outperforms other blood tests like CA-125 and ROMA, reduces false negatives, and detects all types of ovarian cancer. Aspira Women's Health continues to work with researchers to discover how OVA1 (MIA) can improve ovarian cancer detection and outcomes for women.
Clinical Validation Study 5,8
In the pivotal study by Bristow, et al., OVA1(MIA) with clinical assessment:
OVA1 Performance and Ethnicity
Superior detection of ovarian malignancy risk in African American women is shown in data from our clinical studies. OVA1 has a 46% higher rate of detection (sensitivity) for ovarian malignancy vs. CA-125 in African American women.14
Detecting Early Stage Cancer5,9
Bristow, et al.’s (5) clinical study was the second pivotal trial of OVA1 (MIA) with 494 surgeries and 92 cancers. The results of this study validated OVA1’s standalone sensitivity of 92% and OVA1 (MIA) with Clinical Impression of 96%. The data showed a significant difference in the sensitivity between CA-125II standalone vs. OVA1 (MIA) standalone to capture early-stage cancers (stage I and II):
Sensitivity By Stage
|Assay Alone||Stage 1||Stage 2||Early Stage||Pre-menopausal Early Stage||Post-menopausal Early Stage|
*Intended use is with clinical assessment
Longoria, et al. further studied risk assessment of early stage cancers by comparing CA-125II, Clinical Impression, and the modified ACOG guidelines to OVA1 (MIA) across the two OVA1 pivotal trials (N=1,016 surgeries with 86 early-stage cases; 62 stage I, 24 stage II). OVA1 (MIA) showed statistically superior sensitivity for risk stratification. Adding OVA1 (MIA) to Clinical Impression reduced early-stage cancers missed from 31% to just 5% (85% reduction). Early-stage detection enables appropriate referral and surgery to avoid potential for upstaging.
Rate of Cancer Detection by Types of Risk Assessment
This large, prospectively enrolled, multi-institutional study demonstrated that use of OVA1 detected more early-stage malignancy than the current standard of care.– Longoria, et al.
Detecting Cancer Across Menopausal Status5,8
The patient cohorts of the two pivotal trials (Bristow et al. and Ueland et al.) can be evaluated based on menopausal status. The data showed that 91% (69/76) of cancers in pre-menopausal and 98% (173/177) of cancer in post-menopausal were detectable with OVA1 (MIA) with Clinical Impression. See chart for the break down.
The multivariate index assay demonstrated higher sensitivity and lower specificity compared with physician assessment and CA-125 in detecting ovarian malignancies.– Ueland et al.
Detecting Cancer Subtypes**
Different types of ovarian cancer are diagnosed depending on where they start in a given cell. In the pivotal 2013 Bristow, et al. study also included the effectiveness of using OVA1 (MIA) to detect ovarian cancer subtypes. OVA1 (MIA) detected epithelial ovarian cancer (EOC) at a 99% rate compared to CA-125 at 89%. OVA1 (MIA) also had a higher detection rate among non-epithelial cancer (Non-EOC) at a 92% compared to 76 percent for CA-125. The study reemphasizes OVA1’s sensitivity to menopausal status, ovarian cancer stage, and ovarian cancer subtypes including:
- Mixed and undifferentiated
- Clear cell
- Sex cord-stromal
- Germ cell
**Data on file based on cohort from Bristow. et al., Obstet Gynecol 2013;128:252-259
Considering the high sensitivity and negative predictive value, utilization of OVA1 as a risk stratification instrument would be associated with retention of over 50% of patients with benign adnexal masses, ensure that more than 96% of retained surgical patients would not have ovarian cancer, and provide appropriate referral to a gynecologic oncologist for over 95% of patients with ovarian cancer.– Bristow et al.12
Predicted Impact on Referral Rates
Bristow, et al. also evaluated the referral rate of using different modalities of pre-surgical pelvic mass risk assessment. The study demonstrated that use of OVA1 (MIA) was associated with referral patterns comparable to actual clinical practice and with higher sensitivity for malignancy than any individual option12. OVA1 (MIA) has a 56% referral rate while other options have a 60% referral rate.
OVA1 was associated with a gynecologic oncologist referral rate (56%) comparable to actual clinical practice (60%) and had higher sensitivity for malignancy than clinical assessment, CA125, and modified ACOG guidelines.– Bristow et al.
Download Clinical Summaries
- Carney ME, et al., Gynecol Oncol. 2002 Jan;84(1):36-42.
- Earle CC, et al., J Natl Cancer Inst. 2006 Feb 1;98(3):172-80
- Ueland, FR et al., Gynecol Oncol. 2005 Nov;99(2):400-3
- Goodrich ST, et al., Am J Obstet Gynecol. 2014 Jul;211(1):65.e1-65.e11
- Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
- Timmerman D, et al., Ultrasound Obstet Gynecol 1999;13:11–16
- Levine D, et al., Ultrasound Q. 2010 Sep;26(3):121-31.
- Ueland FR, et al., Obstet Gynecol. 2011;117(6):1289-1297
- Longoria TC, et al., Am J Obstet Gynecol. 2014 Jan;210(1):78.e1-9
- Moss EL, et al., J Clin Pathol. 2005 Mar; 58(3): 308–312.
- Petignat P, et al., Eur J Cancer. 2000 Oct;36(15):1933-7.
- Bristow RE, et al., Am J Obstet Gynecol. 2013 Dec;209(6):581.e1-8
- American Congress of Obstetricians and Gynecologists, Practice Bulletin 174; 2016 Nov
- Dunton, C., Bullock, R., Fritsche, H.A., (2019). Ethnic disparity in clinical performance between multivariate index assay and CA125 in detection of ovarian malignancy. Future Oncology, https://doi.org/10.2217/fon-2019-0310