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A New Zealand medical technology company that has enjoyed broad success in the US is being shunned at home - and its chief executive Teri Thomas says she has to speak out "on behalf of New Zealand women".
Thomas says Volpara's measure of breast density - an accepted cancer risk measure in the US and Europe - would help identify those at risk overall, and help prioritise at a time when BreastScreen Aotearoa has a backlog of some 30,000 mammograms to reach pre-Covid levels.
But the Ministry of Health is standing by its decision not to adopt the Kiwi company's software.
Volpara Health's software for early detection of breast cancer is used by more than 2000 facilities, including top US cancer screening centres, says the Wellington-based firm.
Tech giant Microsoft is an R&D partner on Volpara's artificial intelligence (AI) technology, used to analyse mammograms. Volpara also makes software for managing radiology clinics, and managing communications with patients.
Accelerating adoption of Volpara's products offshore resulted in its revenue rising by 32 per cent to $26.1 million in the year to March.
But its home market was almost completely out of the picture, with 98.4 per cent of the company's income coming from the US and Australia.
"We would love to continue growing in NZ, however we don't have a lot of activity here right now," Thomas told the Herald.
"There is a focus on getting women in for mammograms. BreastScreen Aotearoa is working with systems integrators on a custom solution that I believe lacks AI, communication to women about their density and has no risk calculation. We hope that our NZ market will evolve and we'll find more customers interested in our level of sophistication eventually."
BreastScreen Aotearoa (BSA) is a free national breast screening programme for women aged 45 to 69. It is part of the National Screening Unit within Te Whatu Ora – Health New Zealand.
Women with dense breasts - or a low ratio of fatty tissue - have a higher risk of getting breast cancer.
The Herald put Thomas' critique to the Ministry of Health.
A spokesman responded that there are no plans to mandate breast density analysis for the radiologists who assess mammograms for BreastScreen Aotearoa.
"There is a high threshold for introducing changes to population health screening programmes to ensure that any changes will benefit the screening population and potential risks for those participating are minimised," the spokesman said.
"There are difficulties in grading breast density and a lack of evidence that additional monitoring of women with dense breasts will reduce deaths from breast cancer. There are also harms of additional monitoring to consider, such as causing anxiety, unnecessary needle biopsies, over-diagnosis and cost."
Overall, the harms are likely to outweigh the benefits, the Ministry spokesman said.
He added, "currently, there is insufficient evidence to demonstrate the effectiveness of using artificial intelligence in organised breast screening mammograms."
The Ministry of Health and Te Whatu Ora are involved in research undertaken by Victoria University of Wellington to explore AI's use in reading mammograms and continue to monitor new evidence as it emerges, the spokesman said.
"I struggle with responding because I think BreastScreen Aotearoa does an amazing job at saving lives through screening and the work they do is incredibly important for our wāhine," Thomas said.
"I don't want to criticise them. But I find myself in the situation in which I need to address it on behalf of our NZ women.
"Frankly, I think they can set their sights higher and tackle this really important and complex challenge by better leveraging the modern tools and knowledge that are globally available."
Thirty-eight of 50 US states require women to be informed of their breast density, Thomas said.
"I have worked in healthcare in Europe, the US, and the Middle East - in addition to NZ and Australia - and I find it odd/frustrating when I hear BSA say they are waiting for more research before providing important information to their populations. I don't know what they're waiting for. The US has been reporting and acting on breast density for some 10 years now using the BI-RADS standard reporting framework [which includes an assessment of breast density]."
Simply being made aware of their breast density would motivate women to get regular screenings, Thomas said. It has been estimated that some 271,000 women have not taken advantage of the free mammogram every second year that BreastScreen Aotearoa offers.
"I believe in empowering and informing women versus not even giving them the option of knowing information - that could be very important - about their bodies. For my own personal breasts and mammograms, I really want to know my density."
The Volpara boss also said the Ministry had the wrong end of the stick with its comments about artificial intelligence, which her company does not direct do at present, although it has an R&D collaboration with Microsoft that could see AI for computer-aided detection added in future.
"While the latest AI for computer-aided detection looks promising, I agree that we could use more large-scale prospective trials done to show the benefit in population screening programs such as BreastScreen Aotearoa. This is an area Volpara continues to watch given the sheer scale of the unique data we're collecting, and it's an interesting future opportunity for us due to the global shortage of radiologists," she says.
Thomas says some of the National Screening Unit's guidelines date from 2013.
"Evidence has changed since then and it's simply out of date."
She points to the 10-year DENSE trial in the Netherlands, saying the 10-year randomised controlled trial showed that using Volpara to select those women with extremely dense breasts and then having breast MRI performed led to a significant drop in interval cancers (cancers that appear between screenings and tend to be more aggressive).
And she note a March recommendation by the European Society of Breast Imaging for MRI screening for women with dense breasts.
"Some women with dense breasts will have a higher risk of breast cancer compared to women with a first-degree family member diagnosed before menopause."
The US, Western Australia, and various European countries all manage to report and act on breast density within population screening programmes, Thomas said.
The new European guidelines, "call out breast density as increasing breast cancer risk, but if women request this info from BreastScreen Aotearoa they cannot access it because it is not currently recorded," Thomas says.
Last month, it was revealed that about 30,000 Kiwi women are overdue for breast cancer checks under the BSA programme, due to pandemic disruption.
"With the Covid-related backlog of screening mammograms, looking at density and risk factors and prioritising the highest-risk women makes extra sense to me. Unfortunately, this appears to be put off to some unknown future time."
Thomas, who worked in the health sector in the US before shifting to New Zealand where she worked as vice-president, global sales, marketing and strategy for Orion Health in 2017, sees a pattern of NZ's health system failing to move with the times.
"During my work for Orion Health, I was shocked by the Kiwi tolerance for low-tech tech," she said.
"The healthcare system in New Zealand is good overall, but there is a big deficiency, which is use of technology. Our leadership lacks appreciation for what is possible, and what is deployed in Europe and the US. Most first-world hospitals I'd worked with had retired pen and paper prescriptions, for example, and for very good reasons."
In 2020, after Orion de-listed, Thomas took the unusual step of leaving her business career behind to embark on a nursing degree.
"I thought I might retire here. However, I am too young and I want my life to make a positive impact on the world. I am grateful for all of the opportunities I've had in my life and wanted to give back in some way."
Her career switch led to frontline experience that reinforced her view that New Zealand is behind the play.
"Getting a Masters in nursing allowed me to get a much deeper understanding of New Zealand healthcare. I trained in three different DHBs and was able to get an intimate knowledge of New Zealand health workflows.
"My intent was to be a nurse and look for ways to support national technology efforts and likely move to nursing informatics and help at a national level."
In the end, part-time work for Volpara at the same time led to her current full-time role.
But before that, "I did nursing at Whakarongorau Aotearoa as a Covid nurse, checking on higher-risk people diagnosed with coronavirus. My assessment of New Zealand use of healthcare technology remains the same: we have a huge opportunity to do better and we are not on par with other first-world nations."
New Zealand is amongst the countries with the highest prevalence of breast cancer. Around 650 New Zealand women die from breast cancer every year.
"What's really sad to me is that nearly 10 per cent of breast cancers are diagnosed before age 50, and those are often more aggressive and/or found at later stages," Thomas says.
"I think we can do better for women, and as the number one cancer diagnosed in women, it's so important. Heck, even informing women about breast cancer risks may improve the percentage who get mammograms, which I know is a focus for BreastScreen Aotearoa."
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