- Volpara Health Technologies (VHT) has revealed a strong second round of results for the Project DENSE breast cancer detection trial in the Netherlands
- The results show a reduction in false-positives from the VolparaDensity tech, which is the company’s MRI breast screening device
- The long-term DENSE trial is the first randomised controlled study on the clinical utility of MRI breast screening for women with extremely dense breasts
- Typically, dense breast tissue can make conventional mammograms difficult to interpret because it looks the same as cancer on the mammogram
- The VolparaDensity tech is one of the features of the DENSE trial, which first started enrolling patients 10 years ago
- Volpara shares spiked this morning but ended up closing grey at $1.30 each
Volpara Health Technologies (VHT) has revealed a strong second round of results for the Project DENSE breast cancer detection trial in the Netherlands.
The first round of Volpara results from the trial were released in late-2019 but showed a high false-positive rate from the Volpara technology. The company said this rate has dramatically fallen in today’s second batch of results.
The Project DENSE trial
According to Volpara, the long-term trial is the first randomised controlled study on the clinical utility of supplemental MRI breast screening for women with extremely dense breasts.
Typically, dense breast tissue can make it difficult for clinicians to interpret conventional mammogram screening because cancer and dense breast tissue can look similar on the mammogram.
The Netherlands-based DENSE trial, which started enrolling patients ten years ago, features the VolparaDensity as a breast screening device. VolparaDensity uses X-ray physics and machine learning to accurately measure breast volume and composition.
In the first round of results from December 2019, Volpara’s tech showed a significant reduction in interval cancers in women being selected for breast MRIs using VolparaDensity.
However, while this was encouraging, Volpara said it had a relatively-high false positive rate of 79.8 per 1000 screening examinations.
The newest batch of results from today, which involved 3000 women, show this false positive rate has reduced to just 26.3 out of 1000 examinations.
Yet, inversely, the VolparaDensity incremental cancer detection rate was lower in the second round than in the first — at 5.8 per 1000 screening examinations in today’s results versus 16.5 per 1000 in 2019.
Nevertheless, Volpara management said a lower rate of interval cancer detection was expected in this second round.
“The first results from DENSE showed a dramatic decrease in the number of interval cancers by varying screening based upon VolparaDensity,” CEO Dr Ralph Highnam said.
“These follow-up results demonstrate that as screening programs settle into
these new protocols, the number of false positives is significantly reduced and makes the new protocol much more viable,” he said.
“We are incredibly proud to be part of this work, which has been a 10-year journey for us and the investigators but is showing a real benefit to women.”
Shares in Volpara Health Technologies climbed as much as 4.2 per cent in early market action today but gradually gave back the taken ground over the course of the trading session.
By market close, Volpara shares were grey at $1.30 each.