New Breast Cancer Blood Test Now Available at Avera
By: MED Staff
More than half of women who have annual mammograms with have at least one false positive results over a ten year period. Of these, about 10 percent will be recommended for biopsy.
Fortunately, most of the time (70 to 90 percent), those biopsies are benign. Unfortunately, between the recommendation for further testing and the pathology report, there can be significant stress, anxiety, discomfort and, in many cases, procedures that might have been
“We need to do a better job finding the women who really need a biopsy,” said Tricia Merrigan, MD, Avera Medical Group breast surgeon in an interview with MED. “This is where Videssa can play a great role now.”
Videssa Breast, developed by Provista Diagnostics, Inc., is the first blood test for the specific protein biomarkers and autoantibodies associated with breast cancer. Avera Cancer Institute was one of just 13 sites nationally to help validate the new test over the last five years, and the only site in the Midwest. Avera Breast Center Director of Mammography Josie Alpers, MD, was primary investigator and co-author of the Videssa study published in the June 2017 issue of Journal of Clinical Breast Cancer.
“This is very exciting work,” said Dr. Alpers,
noting that Videssa and the research surrounding it has been accepted as part
of the federal government’s Cancer Moonshot program. “When a mammogram yields
an abnormal result, the challenge is to decide which patients need follow-up,
further imaging or biopsy. A test that is well-validated in a prospective trial
means clinicians have a new way to accurately identify which patients may or
may not need additional follow-up.
In the trial cohort of women under 50, the negative predictive value of Videssa was 99.3 percent.
“This is huge because the population was enriched,” says Alpers. “All of these women had lumps or something suspicious in their findings.”
Significantly, in younger populations, Dr. Alpers says 30 to 40 percent of cancers may be missed by mammograms because of the density of their breast tissue. Bust breast density makes no difference with VIdessa.
“When you look at some of the reasons why some of the societies argue that younger women should not have mammograms, it is because their imaging is difficult and the findings can be confusing - not because they don’t get cancer,” says Dr. Merrigan. “Younger women do get breast cancer and their tumors tend to be more aggressive. We just need a better way to sort them.”
Videssa has the potential to make that sorting easier and at half the cost of a biopsy and a fraction of the cost of an MRI.
“The results tell us that this test is
extremely effective in ruling out breast cancer,” Alpers said. “After an
abnormal mammogram, this is exactly what women need to know. Videssa allows us
to confidently give women assurance that they do not have breast cancer, or advise
them that they should have further testing, such as biopsy.”
When used in conjunction with breast imaging tests such as digital mammography and contrast-enhanced spectral mammography (CESM), Videssa could reduce the need for breast biopsy by up to 67 percent. ACI is an early access site for the new test and is now using it in its day-to-day breast cancer diagnostic care, primarily in low-risk women who have multiple suspicious lesions.
“The test is still in its infancy so we are being very conservative in our utilization, but it has amazing promise,” says Dr. Alpers.