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.
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
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
Aspira Women’s Health is Dedicated to Transforming Women’s Gynecologic Health. We are always looking for clinical sites interested in partnering with us in pursuit of this mission. If your clinic is interested in participating in a clinical study, please fill out the contact form below: