- Volpara Health’s (VHT) breast density assessment software takes centre stage as the US FDA releases new dense breast tissue regulation
- The new regulation requires mammography facilities to notify women of dense breast tissue on examination
- The ruling will come into play within the next 18 months, and will expand the number of states with density disclosure laws in the US
- Volpara says its volumetric breast density assessment software to support physicians has been validated by the FDA via this new ruling
- VHT shares are up 11 per cent, trading at 75.5 cents at 11:50 am AEDT
Volpara Health Technologies’ (VHT) breast density assessment software has taken centre stage following the US FDA’s new federal regulation on breast tissue.
The regulation requires mammography facilities to notify women via patient reports if their breasts are composed of dense tissue.
Volpara’s focus is on the early detection of breast cancer, led by its volumetric breast density assessment software, Volpara TruDensity, which has been cleared by the FDA, Health Canada, and the TGA.
Dense breast is common, although it has been linked to an increased risk for breast cancer and decreased early detection.
The new FDA regulation will increase the number of states in the US carrying density disclosure laws and provide standardised care to women nationwide, using VHT software.
The regulation states that within the next 18 months, all patient reports must include a summary outline of non-dense breast results as well as dense breast notifications.
VHT said that its software supported physicians in making accurate and objective assessments of breast density for up to 6 million people every year.
“We’ve been working with leading clinicians and researchers around the world for more than a decade to make critical information about women’s breast composition and its link to breast cancer more readily available,” CEO of Volpara Health Teri Thomas said.
“The FDA regulation validates our focus, increases the industry’s attention on breast density, and propels us forward to improve both the patient and provider experience and understanding Ms Thomas said.”
VHT shares were up 11 per cent and trading at 75.5 cents at 11:50 am AEDT.