NEW YORK – With recent deals in the UK and the US for its artificial intelligence-based Galen digital pathology platform, Ibex Medical Analytics expects the continued adoption of its technology by pathologists.
"The momentum in the UK is very strong and picking up, and we are starting to see markets like the US follow that momentum," Stuart Shand, its chief commercial officer, said in an interview.
Earlier this month, Ibex announced that it had secured several contracts to offer Galen Prostate and Galen Breast to 25 UK National Health Service trusts taking part in the Pathology Image Data Lake for Analytics, Knowledge, and Education (PathLAKE) consortium, set up in Coventry in England in 2018 to support the uptake of digital pathology in the country. It originally received £10 million ($12.2 million) in funding from Innovate UK, the government's innovation agency, to support its efforts, and in 2020, the UK invested another £13.5 million in the endeavor.
Founded in 2016, Ibex has offices in Tel Aviv, Israel, and in Boston. It employs about 75 people worldwide. The company's main software products are Galen Prostate, Galen Breast, and Galen Gastric, all of which can be integrated into existing digital pathology workflows to improve the diagnoses of these cancers.
Traditionally, pathologists have relied on examining tissue samples with microscopes to detect signs of cancer and provide a diagnosis. The advent of digital pathology has facilitated the use of whole-slide image scanners to digitize glass slides, which are then analyzed using an image viewer, often a computer. By doing so, digital pathology can provide a faster diagnosis of cancer, shortening the time to treatment.
According to Ibex, its tools are used by customers to prioritize case work lists, view slides, preorder immunohistochemistry analyses, produce cancer heatmaps, grade and measure tumors, and integrate non-cancer findings into reports. The company says that its products increase the accuracy of diagnoses, reduce turnaround time, and improve overall productivity.
For five years, PathLAKE has strived to digitize pathology in the consortium's trusts while also implementing AI-based diagnostic tools. With the contracts awarded earlier this month — the amounts of which Shand declined to provide — trusts and universities involved in the consortium can now procure Ibex's Galen Prostate and Galen Breast.
Shand said that Ibex is already working to secure contracts with five of the sites participating in PathLAKE and said that the company is liaising with these customers.
"This will allow them to add Ibex AI to their existing digital workflow," he said. What that means is that the digital images they are creating can now be connected to a cloud server where they are analyzed using Galen. "The AI is able to feed back the clinical findings, measurements, and hotspots that support the pathologists in making a diagnosis," Shand said.
Along with its offerings for breast, prostate, and gastric cancers, Ibex plans to launch a product for diagnosing colon cancer later this year, he added.
As the adoption of digital pathology becomes more common, the list of firms entering the space with products to address the needs of the market keeps growing, and in addition to Ibex, Helsinki-based Aiforia also received contracts with PathLAKE for its Clinical AI Model for Prostate Cancer: Gleason Grade Groups offering, as well as its Aiforia Clinical AI Model for Lung Cancer: PD-L1 product. Both products offer AI-powered clinical decision support to pathologists and carry CE-IVD marks.
According to Shand, AI-based platforms are being adopted across the UK with increased frequency. He pointed out that NHS Wales' six university health boards will all soon be using Galen Prostate, and he said the Industrial Center for AI Research in Digital Diagnostics (iCAIRD) in Glasgow, Scotland, has also been implementing Galen Breast. Like PathLAKE, iCAIRD received £10 million in 2018 to support the adoption of AI-powered digital pathology in Scotland.
This adoption is also increasingly mirrored in the US. Earlier this month, Ibex expanded an agreement with Alverno Laboratories, a Hammond, Indiana-based laboratory network, that will see Alverno deploy Ibex's Galen suite to its entire network in Illinois and Indiana, including the Chicago area. According to the firms, the deployment will cover about 30 hospital labs serving 8 million people. Alverno said it will combine Galen with the Philips IntelliSite Pathology Solution, a high-throughput platform that supports scanning, image viewing, and data storage.
"For Ibex, we have seen real momentum in the US, which is built on the momentum we have seen in the past couple of years in Europe," said Shand. "That market is really accelerating, and I think Alverno is a great example of what labs can do with digital pathology and AI."
Galen Prostate is compliant with the EU's new In Vitro Diagnostic Regulation, which began to apply last year and requires that most IVDs undergo conformity assessment by an EU-designated notified body in order to obtain a certificate. The company has not yet announced CE-IVD marks for Galen Gastric and Galen Breast under the IVDR, but Shand said they are on the way. Both offerings were already CE-IVD marked under the IVDD.
In 2021, the US Food and Drug Administration designated Galen as a breakthrough device, which enables close cooperation with the FDA and an expedited review, he noted.
In addition to its contracts with PathLAKE, in January, Ibex announced a partnership with AstraZeneca and Daiichi Sankyo to work on a new feature for Galen Breast that will help pathologists better score human epidermal growth factor receptor 2 (HER2) in breast cancer patients.
Shand said that AstraZeneca and Daiichi Sankyo have developed a therapy for breast cancer — the antibody-drug conjugate Enhertu (trastuzumab deruxtecan) — that is particularly suited for patients with low HER2 expression. Ibex's Galen Breast product is now being configured to spot patients who fall into this HER2-low group and could benefit from the therapy. Validation sites have been selected across the US, UK, and Europe, and the validation study has already commenced, but Shand did not discuss a timeline for when the new feature would be available.
When it is, it would compete with other firms, such as Paige, a New York City-based digital pathology company, which offers an AI-based product called HER2Complete that is similarly intended to identify HER2-low breast cancer patients that are missed by conventional tests. The company announced CE-IVD and UK Conformity Assessed marks for the offering last June.
In the meantime, the company is consolidating its position in the UK. Shand referred to the uptake of Ibex's offerings within NHS Wales as a particular "success story."
David Bailey, associate divisional director for pathology at the Northwest Anglia NHS Foundation Trust, said in an email that digital pathology has been adopted so far by only a handful of a histopathology departments across the UK, though many are in the process of implementing the platforms and validating the technology. He predicted that by the end of 2024, more than 75 percent of UK labs will be using digital histopathology for the majority of specimen reporting, though.
He added that limited numbers of AI algorithms have been approved for use in the NHS to date, but that more are currently being assessed for use, including Ibex's Galen Breast, which he noted has been "validated for clinical use overseas, most notably in Israel and Europe."
Bailey said that North West Anglia is participating in a new trial, funded by the UK National Institute for Health and Care Research, that will "assess the cost effectiveness and optimal use" of Galen Breast in the context of NHS's pathology workflow. The trial will start next month, he added.
According to Muhammad Aslam, a consultant pathologist and clinical director of North Wales managed clinical support services at Betsi Cadwaladr University Health Board, three of the country's six health boards have adopted Galen Prostate, and the other three are setting up the infrastructure to do so. NHS Wales is organized into regional health boards, while NHS England is organized into regional or specialized health trusts.
Aslam said that for prostate cancer, existing AI-based diagnostic tools on the market — such as Ibex's Galen Prostate or Paige's Prostate Biomarker Suite — are "very developed," and that he considers them to provide additional support for diagnosis.
"It's just like using a calculator," Aslam said. "I use it to expedite things and it helps me and my colleagues in highlighting areas, finding points of interest, and doing the analyses," he said. "It's a tool to help me, and that's why it's being heavily accepted."
Just five years ago, though, AI-based digital pathology tools were considered bleeding-edge technology. Paige was founded in 2017, one year after Ibex, while Aiforia was founded in 2013. Other companies in the space include Proscia, Mindpeak, and Inspirata, which was acquired by Fujifilm in December.
Aslam said he was skeptical at first about the technology, but that the tools have since proven themselves. Now, it only remains for them to be adopted, which is easier to do in smaller health systems like those in Wales, in part because it takes time to move pathologists to digital platforms before they can use the tools.
"You cannot upgrade the infrastructure for a whole country in a big bang approach because it will cost an absolute fortune," said Aslam. "That is why this is happening in small pockets," he said, noting that his lab has been using Galen Prostate since 2021, and predicted future adoption across other disease areas.
"These kinds of tools will be used in day-to-day practice in every specialty," said Aslam. "This is not going to stop at prostate."
Shand described the adoption of Ibex's products in Wales as the "first ever nationwide development of AI," and said that every prostate sample that goes through its labs will eventually be analyzed using the Ibex technology. Like Aslam, he also underscored the progress that has been made toward adoption of AI-based tools in digital pathology in the UK.
"We have really seen tremendous progress over the past five years in terms of companies' ability to digitize, but also labs' abilities to incorporate and deploy that technology," said Shand. "We literally have millions of images being digitized every day, and those images provide us with not only information to be able to analyze but also a canvas through which we can present back findings to support the pathologist."