The FDA just gave breast screener Volpara a major leg-up in the US
Health & Biotech
Breast cancer tech stock Volpara Health Technologies (ASX:VHT) is rubbing its hands together over a decision by the US Food and Drug Administration to introduce mandatory reporting of breast density in mammograms.
Breast density data can help clinicians make more informed decisions about breast cancer risk, and so the FDA says it will require all US screening facilities to provide information on breast density to women and their healthcare providers after a mammogram.
Volpara chief Dr Ralph Highnam says this will result in “increased commercial opportunity” for its Volpara Density software, an automated breast density solution available to customer clinics.
It sells breast cancer screening software via the SaaS model, which it says lifts the accuracy of breast cancer diagnoses.
The company has been rapidly expanding its US operations, and says by the end of the financial year 9 per cent of US women being screened will be analysed by a Volpara product.
“This is a major step forward for the women of the United States. No matter where they live, they are about to receive information regarding an important part of their breast health for them to monitor and act on with their healthcare professionals,” Dr Highnam said.
The changes will see four categories established for reporting breast density, in language able to be “readily interpretable by women receiving the letters” followed by a more detailed report sent to doctors.
“We’re trying to facilitate a conversation about breast cancer screening between the patient and their healthcare professional,” FDA director Dr Jeff Shuren said.