ASX Health Stocks: Volpara jumps 10pc as US FDA makes new ruling on 'dense breasts' language

Volpara’s share price rose 10% this morning after the US FDA finalised a new federal regulation on breast density language
Anatara’s provides strong update on Irritable Bowel Syndrome trial

Volpara Health (ASX:VHT) rose 9% this morning after the US FDA finalised a new federal regulation requiring mammography facilities across the country to inform patients whether their breasts are composed of dense tissue.

The regulation stipulates that within the next 18 months (by 10 September 2024), all patient reports and summaries must include the following language about breast density:

Non-dense breast notification states: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

Dense breast notification states: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

The new ruling will significantly benefit Volpara as nearly 40 million mammograms are performed each year in the US, of which Volpara’s software is used to assess the breast density of more than 6 million annually.

Volpara’s volumetric breast density assessment software has long been used by physicians in making objective assessments of breast density.

The company’s proprietary technology, the Volpara TruDensity AI algorithm, has been cleared by the FDA, Health Canada, and the TGA (Australia), is CE-marked, and has been validated in more than 400 articles and research abstracts.

“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,” said Volpara CEO, Teri Thomas.

“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.”

Dense breasts hinder cancer detection

Dense breast tissue is common, but has been linked to an increased risk for breast cancer and can also dramatically impact early detection.

In the US, nearly half of all women over 40 have dense breasts. As density increases, the accuracy of mammography decreases, and data suggests that mammography misses almost half of breast cancers in women with the densest breasts.

Because dense breast tissue and cancer appear white, tumours are often camouflaged on a mammogram.

Studies confirm that early detection improves when women with very dense breasts receive an ultrasound or MRI exam in addition to mammography as part of their regular screening schedule.

“The FDA breast density notification language is a key step in equitably empowering all women in the United States to understand their breast density so they can take informed, actionable steps to monitor their own breast health,” said Thomas.

Volpara share price today:

Anatara’s update on Irritable Bowel Syndrome trial

Meanwhile, Anatara Lifesciences (ASX:ANR) announced that a revised protocol for its Irritable Bowel Syndrome (IBS) trial of “GaRP” 200 patients has successfully been implemented, with enrolment now on track to be completed.

Recruitment for Stage 1 is expected to be completed in early 2Q 2023, with approximately 50 out of 90 Stage 1 patients already enrolled.

Anatara says the trial is on budget with interim read-out of results anticipated early Q3 of this year.

A licence agreement has also been executed with a specialty junior private healthcare company, Mucpharm, to licence the technology from Anatara for use in specific fields of interest, particularly mucin-producing cancers and biofilms.

The company says the Mucpharm agreement has the potential to provide Anatara with royalties on sales and sub-licensing in the future.

Mucpharm is a specialised company focused on the treatment of mucin-containing and secreting conditions.

It is developing the novel use of “BromAc”, a combination of bromelain and acetylcysteine, in specific fields including cystic tumours.