CHICAGO – By virtue of a recently announced partnership with Congenica, Scottish startup Gabriel Precision Oncology hopes to achieve its founders' vision of making genomic testing for cancer more routine by delivering tests and results analysis that seamlessly integrate with care processes.
Gabriel, a 2020 spinout from the University of Glasgow's Glasgow Precision Oncology Laboratory (GPOL) in the UK, offers a pipeline of data from cancer tissue samples that feeds genomic analysis systems. Congenica plans on building a new platform incorporating this pipeline into its existing software to support rapid interpretation of somatic cancer data. By doing so, the partners hope to make next-generation sequencing a central component of routine molecular pathology testing to increase diagnostic efficiency and ultimately drive better patient outcomes.
The partnership with Congenica is Gabriel Precision Oncology's largest commercial partnership to date, according to University of Glasgow professor Andrew Biankin, one of three founders of Gabriel. It also marks Cambridge, UK-based Congenica's entry into somatic oncology.
Under the partnership, the companies are building an automated system that they said will enable cancer molecular diagnostics from multiple NGS assays.
"People miss out on new therapies because they don't get tested," Biankin said. He said that health systems, including public programs like the UK's National Health Service, have struggled to deliver genomic tests as a part of cancer screening.
After GPOL started in 2016, the lab developed the Glasgow Cancer Assays, meant to bring testing into the "real world," Susie Cooke, head of medical genomics at GPOL and a Gabriel cofounder, has previously said. The third founder and chairman at Gabriel, Philip Beer, heads assay development.
"We're looking forward to a day where every cancer patient gets a comparable standardized test, where we can accumulate data from the real world, we can pull those granular datasets together, and really inform and accelerate how we treat, care for, and prevent cancer," Biankin said.
Biankin said that the Glasgow Cancer Assays are based on data from the International Cancer Genome Consortium (ICGC), the Pan-Cancer Analysis of Whole Genomes, and genomic oncology databases worldwide. Biankin serves as executive director of the ICGC.
Working with Agilent Technologies, GPOL launched the wet chemistry component of the targeted sequencing panels in late 2019. Those assays are now distributed in the UK, the US, and China, and are starting to see use in continental Europe and Australia, according to Biankin.
But pilots showed that while health systems around the world could easily handle the wet-lab work, they often were unable to analyze the resulting data, even when they had access to an analytics pipeline that Cooke led the development of.
"The solution to us was to spin out a company and develop a product … that is available either through a cloud or a licensing arrangement where you could do a pay-per-use model and you didn't have to be a world-leading informatician to be able to do the analysis," Biankin said.
Gabriel's analytics platform is optimized for the Glasgow tests. Biankin said that it has been tested in more than 1,000 samples, particularly in Precision-Panc, a Cancer Research UK-funded project chaired by Biankin that supports data-driven precision approaches to pancreatic cancer.
"I would say [the Gabriel analytics platform] is a niche product, but 350,000 people are diagnosed with cancer a year in the UK, so it's a big niche product," Beer said.
He further noted that the US is ahead of the UK in terms of cancer genomics, but US oncologists generally send out samples to external labs like Foundation Medicine, Caris Life Sciences, or Tempus. Some of those testing firms are trying to penetrate the European market, but have not had much success yet, he noted.
"It's been apparent to us that that kind of model was never going to work in Europe," Beer said. "I think it's questionable whether it will really be completely successful in America."
In Europe, hospitals want control over the sequencing, Beer said. While owning and operating sequencers is "straightforward," according to Beer, even the largest hospitals in Europe are struggling to run the analytics on sequencing outputs.
That is where Gabriel comes in.
Beer said that the Glasgow collection of tests "fits together" with Gabriel's pipeline, which was designed to support analysis of genomics data from cancer biopsies.
"What we hope that Gabriel will do is to drive the uptake of cancer and cancer sequencing in a way that fits with the European model, so the tissue stays in the hospital, the sequencing is done in the hospital, and we can then help out with the analytics, which is the big pinch point at the moment," Beer said.
Beer said that cancer genomic analytics software has often been optimized to handle formalin-fixed samples sequenced with small panels.
"Whilst we can do these advanced assays, when samples are larger and it's fresh material, it's just not realistic," Biankin said. He said that the cost of acquiring and sequencing "beautiful, perfect platinum-grade samples," in cancer actually is going up, not down.
For example, in the Australian Pancreatic Cancer Genome Initiative — a product of the ICGC's work in in pancreatic cancer — it cost A$10,000 ($7,720) to acquire, sequence, and analyze each sample, Australia native Biankin said.
Congenica's view
"We're aiming to normalize a lot of the current testing that is out there, and by normalizing, we can maximize efficiency of how cancer diagnostics are applied to the market," said Freddie Sharkey, VP of oncology and Europe, Middle East, and Africa sales at Congenica. "Currently it is very splintered and very fragmented."
Sharkey called the entry into somatic oncology an "important step" for the company. "We want to build on what we have previously done in rare disease," Sharkey said, adding that that there is a big "unmet need" in somatic cancer diagnosis and treatment.
The companies want to codevelop an "easily accessible" analytical platform for anyone who performs targeted cancer sequencing, according to Biankin, a surgeon who directs the University of Glasgow's Wolfson Wohl Cancer Research Centre.
The current Congenica platform is for hereditary cancers. "Gabriel allows us to enter the somatic cancer world where we will be addressing both the macropathology market and the hemato-oncology market specifically," Sharkey said.
The partners will codevelop software in hopes of submitting a diagnostic-grade product to regulatory authorities later this year and commercializing a product by the end of the year. Sharkey did not specify which country or region the companies will seek regulatory clearance in first.
Congenica and Gabriel will develop a tertiary pipeline that will feed off Gabriel's secondary pipeline.
Congenica's core technology platform, formerly called Sapientia, is a modular and scalable data analytics system for annotating and clinically interpreting genomic sequence data to support clinical decision-making. The company claims that its system is as much as 20 times faster with tertiary analysis than standard off-the-shelf analytics tools.
As a modular platform, Congenica's technology should be able to handle the codeveloped somatic cancer product as an adjunct module, just like the company's current add-ons for rare disease, prenatal care, and COVID-19. "We see this as another really important module for us that enables us to have access to a completely different market," Sharkey said.
From academia to the marketplace
In the collaboration with Gabriel, Congenica is bringing in its own datasets that it has amassed from customers and public sources such as the UK's 100,000 Genomes Project, and building informatics around Gabriel's pipeline. Biankin called it "productizing" more of GPOL's work.
"Software requires a team to maintain it," Biankin noted. "Every time you're interacting with any operating system or any other software that plugs into it and there's an update, you need to keep mollycoddling it along to make sure it works, which is fine in an academic situation," he said, but maybe not feasible in a commercial environment.
"Now, we have something that worked 99 percent of the time for 1 percent of the people," Biankin said. "We need something that works 99 percent of the time for 99 percent of users."
That means automating the technology so a lab technician can upload sequencing data to a computational platform in the cloud and later receive back "a prepopulated, pregenerated report that they can plug into the electronic health record and it goes straight to the doc," according to Biankin.
The tie-up with Congenica is a completely clinical exercise. "This is to enable health services to do clinical diagnostics to direct care and allocation of clinical trials and treatment decisions," Biankin said, explaining why the joint product will need regulatory clearance.
It will be Congenica's decision which regulators to go to first, such as seeking US Food and Drug Administration clearance, European CE marking, or even an approval in China.
Beer said that Gabriel offers both software and experience to the Congenica partnership. He is a hemato-oncologist and Biankin is a surgeon, and both have worked in drug development. Cooke, the third founder and head of medical genomics at GPOL, is a bioinformatician with a history in cancer biology.
He said that Gabriel and the wider University of Glasgow team want to look at both known and candidate biomarkers so they can better characterize response predictions to various compound and improve identification of patients for clinical trials.
Biankin said that the best way to understand safety and efficacy of treatments in the development and even postapproval stages is to perform "standardized, robust uniform tests across a larger jurisdiction in than one hospital, ideally a health service." That means collecting and analyzing data from the real world.
"In that context, all of a sudden you can use the information from the 96 or 97 percent of patients that never get onto clinical trials and standardize robust comparable measures," Biankin said.
Gabriel to date has been funded chiefly by its academic sponsors, its principals, and revenue generated from sales, according to Biankin. The company has not yet applied for government or private grants, nor has it looked to the venture capital market.