– Longoria, et al.
OVA1 Clinical Studies
OVA1 (MIA) was rigorously validated to determine its effectiveness for evaluating the risk of ovarian cancer prior to surgery. The various trials 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 Labs continues to work with researchers to discover how OVA1 (MIA) can improve ovarian cancer detection and outcomes for women.
83% of cancers missed by clinical assessment were identified by OVA1 (MIA)
71% of cancers missed by
CA-125II were identified
by OVA1 (MIA)
OVA1 (MIA) demonstrated
negative predictive value
of up to 98%
|ASSAY ALONE||STAGE 1||STAGE II||EARLY STAGE||PRE-MENOPAUSAL EARLY STAGE||POST-MENOPAUSAL EARLY STAGE|
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.
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. Here is the break down:
Premenopausal: 91% (69/76) overall sensitivity
- Ueland et al.: 89%
- Bristow et al.: 94%
Post-menopausal: 98% (173/177) overall sensitivity
- Ueland et al.: 98%
- Bristow et al.: 97%
– Ueland et al.
– 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.
- 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
Learn how OVA1 outperforms other blood tests like CA-125 and ROMA.