Diagnostic Blood Test for Breast Cancer May Alleviate Burden of Testing

Videssa

“Videssa is a blood test targeting breast cancer. It's a combination of serum protein markers and tumor-associated antibodies with an algorithm connecting those two data sets to identify the presence or absence of cancer,” noted Commissiong.

“It's a Harvard–ASU intellectual property portfolio combination, with three prospective studies demonstrating 98.4% negative predictive value in over a thousand patients total. The data was collected, and the trials were done at some of the top centers in the country,” he continued.

Issues with Current Diagnostic Tools

Most people know that the current standard of care for women over a certain age bracket is to have yearly mammograms as an annual breast cancer screening. Doctors may advise earlier or more frequent mammograms depending on family history, genetics, and other risk factors. According to the ACS, women of average risk should begin mammography at 45 while those at higher risk should consult a licensed healthcare professional.

Dense Breasts

During his discussion with LifeSciencesIntelligence, Commissiong discussed how mammograms often do not provide much information for people with dense breasts.

“The dense breast is a physiological issue related to mass and vasculature. So, if a patient doesn’t have dense breasts and they don't have very significant blood flow, then the radioisotope can't be properly distinguished in the breast. Therefore, providers have difficulty dissecting the image,” shared Commissiong.

He shared that rather than trying to replace mammograms, which would take thousands of data sets, the team focused on a subset of the population with dense breasts that may have abnormal imaging findings, such as BI-RADS three or four.

According to Commissiong, up to 40% of women with dense breasts have inconclusive mammograms requiring follow-up testing and a biopsy.

“That process is expensive and time-consuming. It creates much anxiety, and most of the time, the answer is there's nothing wrong,” he revealed.

How Can a Blood Test Address These Issues?

Beyond the issue itself, there is the issue of repetitive inconclusive mammogram results. Commissiong states, “the issue is that this happens to the same women repeatedly because of the vasculature issue. Their physiology doesn't change. So, having a blood test to follow an inconclusive mammogram could significantly reduce the number of biopsies needed and provide faster answers on whether a patient is likely not to have breast cancer because of an inconclusive mammogram.”

“That's why the negative predictive value is so important because if there's a real finding, then providers would continue to advance those patients through the diagnostic paradigm. But if it's highly likely that they don't have breast cancer and a biopsy can be avoided, that is very valuable for women,” he added.

Cost-Benefit Analysis of a Diagnostic Blood Test

In addition to reducing the strain and anxiety surrounding mammograms for women with dense breasts. Commissiong also shared how this diagnostic tool may reduce the financial burden associated with repetitive inconclusive mammography results.

“On average, the cost associated with that diagnostic paradigm and biopsy is about $6,000. Obviously, with the backlog associated with COVID, the time frame to get all that done is more challenging. Videssa’s cost would come in at around 10% of that number. So, it'd be a significant saving. Based on the data done by Boston Consulting, Todos Medical believes we can reduce biopsies by up to 45%,” he said.

How Will a Diagnostic Blood Test Impact Provider Workflow?

LifeSciencesIntelligence was especially interested in learning how a diagnostic blood test would impact provider workflow.

“Over 32 states have now mandated that if a woman has dense breasts providers have to inform her of that because they keep going through this biopsy issue every couple of years, creating all this anxiety,” prefaced Commissiong.

“This could be an alternative for women who have dense breasts for whom inconclusive mammograms are standard,” he added.

In addition, Commissiong notes that mammograms carry an additional cancer risk. That is a significant reason that the age limit keeps moving up. “On an accumulative basis, mammograms were causing more cancers than they found,” he commented.

During the conversation with LifeSciencesIntelligence, Commissiong shared that there are two populations he believed would benefit from a test like this. The first group is people at a higher risk of breast cancer who are not yet at a recommended age for a mammogram.

“This is a great way that they can take control of their health, and if there are concerns, they can have a better idea,” he said.

The other population is individuals who have had breast cancer and are concerned about recurrence. While this group may want a mammogram, they must be careful about exposing themselves to factors that may trigger a cancer relapse.

“From a workflow perspective, patients would likely gather blood for the Videssa test at the time of mammogram. Providers can send the blood if there is a need for a secondary evaluation instead of having the patient return for secondary tests. It becomes a part of their normal workup,” explained Commissiong. “Providers would have that available on hand to give a faster answer to patients. Patients could know whether the risk is genuine or if it's just a false test result. Physicians will be empowered with better information to make faster decisions, which could alleviate some of the comprehensive workflows associated with secondary breast cancer screenings.”