NEW YORK (360Dx) – Proteomics firm Provista Diagnostics has completed a study indicating that its Videssa Breast test could eliminate as many as 45 percent of unnecessary breast biopsies.
The Scottsdale, Arizona-based company is now looking for a partner to lead commercialization of the test and for additional funding to drive the commercialization effort, said Gary Altman, Provista's CEO.
Altman was appointed CEO in February 2018, taking over for David Reese, who headed the firm from 2011 to 2017. Altman was previously chief operating officer at Human Longevity.
Altman noted that Provista is also developing a proteomic test for ovarian cancer that it plans, at least initially, to offer as an aid for determining whether a pelvic mass is likely malignant or benign. Such a test, were it to come to market, would compete with Vermillion's OVA1 and Fujirebio's ROMA tests, which are similarly intended for evaluating whether women with pelvic masses are likely to have cancer.
The Videssa Breast test is intended to aid physicians in the interpretation of mammograms, helping them to distinguish between benign and malignant lesions that appear during imaging and to interpret results in patients with dense breasts, which can be difficult to assess via mammography.
Mammogram findings are graded using the Breast Imaging-Reporting and Data System (BI-RADS), a 0 to 6 scale with likelihood of malignancy rising with the number grade. A score of 1, for instance, is considered negative, while a score of 6 is a proven malignancy. Scores in the 3 to 4 range can be challenging to interpret, though. Typically, patients with a BI-RADS score of 3 are monitored for changes in imaging, while patients with a score of 4 are often biopsied.
The Videssa test measures 15 proteins to rule out cancer in women with a borderline BI-RADS score, allowing doctors to avoid unnecessary biopsies. The proteins are a mix of serum protein biomarkers and tumor-associated autoantibodies, some of which were initially discovered by the Biodesign Institute of Arizona State University's Joshua LaBaer and Karen Anderson, who also are members of Provista's advisory board.
The recent study, published last week in Clinical Cancer Research, evaluated the Videssa Breast test in 194 women between the ages of 50 and 75 with mammogram findings of BI-RADS 3, 4, or 5. In that set of patients, the test performed with a sensitivity of 95 percent and negative predictive value of 97 percent, with two out of 38 breast cancer cases being mistakenly scored as benign by the test. The test performed equally well in normal and dense breast tissue, the latter of which can be more challenging for imaging to evaluate.
The effort was part of a larger series of studies evaluating the test in a total of 1,145 subjects ranging in age from 25 to 75 (an overlapping but different panel of proteins is used for testing in patients under 50) that has found the Videssa tests perform with a sensitivity of 93 percent and negative predictive value of 98 percent across the full 25 to 75 age range.
Based on these results, the authors noted that "had Videssa Breast results been integrated into the clinical process prior to biopsy, approximately 325 [out of] 722 subjects (45 percent) might have been able to forego biopsy." This figure is based on results from both the trials' training and validation sets, however.
According to Provista, less than 25 percent of breast biopsies find a cancer, which suggests a place for a test that could help clinicians avoid unnecessary biopsies. However, the company has not been able to drive significant uptake of the test to date.
Provista launched an early-adoption program for the test in 2016 and has since made it available as a laboratory-developed test to any US physicians interested in using it. It offers the test out of its Scottsdale, Arizona-based CLIA facility. According to Altman, around 145 different physicians have ordered a total of 1,500 Videssa Breast tests thus far.
Those relatively modest numbers have led the company to revise its commercialization approach, he said.
"We did have a small sales force, but it was not as successful as we would have liked," Altman said. "We really needed a larger sales force that was more experienced with broader call points."
Given this, Provista has decided to pursue a partnership or licensing agreement with an outside company with a more developed sales staff and infrastructure. Altman said the company is in discussions with several firms about such a relationship and hopes to reach a deal within the next 60 to 90 days.
Altman said Provista also plans to raise additional money to support its test commercialization and development efforts. To date the company has raised around $38 million in funding.
In addition to Videssa Breast, the company is continuing work on its ovarian cancer assay. In February, company researchers published a paper in Biomarkers in Cancer on a panel comprising the proteins CA125, HE4, and three tumor-associated autoantibodies that in subjects scheduled for surgery for a pelvic mass distinguished between benign and malignant masses with 100 percent sensitivity and 84 percent specificity.
As used in the study, the assay would compete directly with Vermillion's OVA1 and Fujirebio's ROMA tests, and if that level of performance held, it would be more effective than either of those existing tests.
The study results are based on a small number of samples (60), however, and of the 17 ovarian cancer patients, only 7 had stage I or II disease, which can be more difficult to identify than later stage cases.
Provista is now collecting samples for another study to validate these initial findings in a larger, independent cohort, said Rao Mulpuri, Provista's chief operating officer and an author on both the Clinical Cancer Research and Biomarkers in Cancer studies.
He said Provista was targeting an enrollment of around 1,000 subjects for the study but that the number would depend on the company's funding situation and input from whatever outside firm it ultimately partners with.