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.

Clinical Validation Study5,8

In the pivotal study by Bristow, et al., OVA1(MIA) with clinical assessment:

83%

83% of cancers missed by clinical assessment were identified by OVA1 (MIA)

71%

71% of cancers missed by
CA-125II were identified
by OVA1 (MIA)

98%

OVA1 (MIA) demonstrated
negative predictive value
of up to 98%

OVA1 Studies Map

Detecting Early Stage Cancer5,9

Bristow, et al.’s (5) 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 ALONESTAGE 1STAGE IIEARLY STAGEPRE-MENOPAUSAL EARLY STAGEPOST-MENOPAUSAL EARLY STAGE
CA-1251164%71%66%46%75%
OVA1*89%100%91%91%92%
*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

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 were detectable with OVA1 (MIA) with Clinical Impression. Here is the break down:

Premenopausal: 91% (69/76) overall sensitivity

  • Ueland et al.: 89% (40/45)
  • Bristow et al.: 94% (29/31)

Premenopausal: 91% (69/76) overall sensitivity

  • Ueland et al.: 89% (40/45)
  • Bristow et al.: 94% (29/31)
100% 50% 0%
89%
94%
Premenopausal
98%
97%
Postmenopausal
Ueland et al.
Bristow 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:

  • Serous
  • Transitional
  • Mucinous
  • Carcinosarcoma
  • Endometrioid
  • Mixed and undifferentiated
  • Clear cell
  • Sarcoma

Non-EOC Subtypes:

  • Sex cord-stromal
  • Germ cell
  • Other
**Data on file based on cohort from Bristow. et al., Obstet Gynecol 2013;128:252-259
OVA1 (MIA) sensitivity across ovarian cancer subtypes
EOC
 
99%
Non-EOC
 
92%
Borderline/LMP
 
86%
Metastic to Ovary
 
100%
aNon-ovarian Malignancy
 
90%
† With clinical assessment
**Data on file based on cohort from Bristow. et al., Obstet Gynecol 2013;128:252-259

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.

CA-125II*
 
68%
Clinical Assessment
 
73%
Modified ACOG guidelines
 
79%
OVA1*
 
90%
OVA1 (MIA) Sensitivity vs Individual Options

“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.

View Sources
  1. Carney ME, et al., Gynecol Oncol. 2002 Jan;84(1):36-42.
  2. Earle CC, et al., J Natl Cancer Inst. 2006 Feb 1;98(3):172-80
  3. Ueland, FR et al., Gynecol Oncol. 2005 Nov;99(2):400-3
  4. Goodrich ST, et al., Am J Obstet Gynecol. 2014 Jul;211(1):65.e1-65.e11
  5. Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
  6. Timmerman D, et al., Ultrasound Obstet Gynecol 1999;13:11–16
  7. Levine D, et al., Ultrasound Q. 2010 Sep;26(3):121-31.
  8. Ueland FR, et al., Obstet Gynecol. 2011;117(6):1289-1297
  9. Longoria TC, et al., Am J Obstet Gynecol. 2014 Jan;210(1):78.e1-9
  10. Moss EL, et al., J Clin Pathol. 2005 Mar; 58(3): 308–312.
  11. Petignat P, et al., Eur J Cancer. 2000 Oct;36(15):1933-7.
  12. Bristow RE, et al., Am J Obstet Gynecol. 2013 Dec;209(6):581.e1-8
  13. American Congress of Obstetricians and Gynecologists, Practice Bulletin 174; 2016 Nov
Education for Providers

OVA1 Versus Market Challengers

Learn how OVA1 outperforms other blood tests like CA-125 and ROMA.