17 July 2019 - - US-based bioanalytical-based women's health company Verm, Inc. (NASDAQ: VRML) has published a paper entitled: "Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk" in the journal Advanced Therapeutics (Shulman et al. Adv Ther. July 2019), the company said.
The study of 993 patients with 245 malignancies shows that Verm's second generation multivariate index assay, Overa (MIA2G), had superior sensitivity to the current standards of care, Risk of Malignancy Algorithm and CA125, in detecting ovarian cancer, and the lowest false-negative rate in correctly characterizing ovarian malignancy risk.
This is the first study published with respect to Overa since it received FDA approval.
Key findings from the study include that Overa exhibited a statistically significant higher sensitivity (91%; 95%CI, 86.8% - 94.0%) of malignancy detection than either ROMA (79.2%: 95%CI, 73.7% - 83.8%) or CA125 (71%; 95%CI, 65.0% - 76.30%), with the current ACOG guidance cutoff of 200 U/ml.
Overa also outperformed CA125 in detection of combined early stage (I and II) cancer with a sensitivity of 90.5% (95%CI, 82.3% - 95.1%) for Overa and a sensitivity of 63.1% (95%CI, 52.4% - 72.6%) for CA125. Overa sensitivity also tended to outperform ROMA (76.2%; 95%CI, 66.1% - 84.0%) in detection of combined early stage (I and II) cancer.
Overa also tended to exhibit higher sensitivity than CA 125 and ROMA regardless of cancer type (epithelial, non-epithelial, low malignancy potential, metastatic, and non-metastatic).
Overa exhibited a significantly higher non-epithelial cancer sensitivity of 75% compared with 50.0% for ROMA, and 37.5% for CA125. This gap is significant as non-epithelial cancers are more prevalent in disparate populations.
Out of the 245 malignancies Overa exhibited the lowest rate of false negatives compared with CA125 (28.9%) or ROMA (20.8%)
As compared to CA125 and ROMA, Overa exhibited the highest sensitivity according to menopausal status. Overa also had identical sensitivity for pre- and post-menopause
Verm's proprietary technologies, OVA1 and Overa, are FDA-cleared blood tests to evaluate cancer risk in women presenting with a pelvic mass, thus helping healthcare providers and women assess risk for malignancy prior to surgery.
Verm is focused on the discovery; development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women.
Verm, along with its scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases.
The company's initial in vitro diagnostic test, OVA1, was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics.
In March 2016, Verm received FDA clearance for Overa, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use.