Imagia Canexia Health Achieves First CE-IVD Status in the E.U. to Deploy Comprehensive Cancer Testing Platform
The Imagia Canexia Health Insights Platform (ICHIP), which provides cancer-treatment analysis directly to local oncologists, is now available across Europe
MONTRÉAL, June 15, 2022 – Imagia Canexia Health, a genomics-based cancer treatment testing company that accelerates access to precision care by combining AI expertise with advanced molecular biopsy solutions, today announced the CE-IVD marking for its Imagia Canexia Health Insights Platform (ICHIP) to operate across Europe. ICHIP provides intricate molecular and computational genome analysis, from targeted next-generation sequencing (NGS) data, for individual cancer patients. The company offers a unique clinical solution for European oncologists to quickly generate reports—including therapeutic and clinical trial recommendations. This new approval furthers Imagia Canexia Health’s mission to combine advanced genomics, oncology, artificial intelligence, and informatics to enable health systems to provide cost-effective testing in-house—thus delivering precision cancer treatments to patients no matter where they live. Clinicians receive next-generation sequencing (NGS) data sourced from human tissue or blood samples. These insights are collected, as well as processed, on Illumina’s NextSeq and MiSeq devices. Then, ICHIP uses AI to detect and analyze genomic variants, match interpretations, identify potential clinical trials, as well as generate a cancer-treatment results report. This creates a new ability to integrate clinical and genomic patient data, augmenting treatment decisions by oncologists. With this crucial information, health professionals can rapidly access data about a cancer patient’s genetics, as well as describe the potential associations between detected variants and specific therapeutics, all while making the most informed care-management decisions. “Achieving the CE-IVD mark, a highly regarded standard around the globe, represents an important milestone that reflects the technological quality and rigor upon which we built the Imagia Canexia Health Insights Platform (ICHIP),” said Imagia Canexia Health CEO Geralyn Ochab. “Our company takes pride in the platform’s ability to quickly provide specialists with vital information to fight cancer, now supporting European oncologists with life-saving information for their patients.”
About Imagia Canexia Health
Imagia Canexia Health (ICH) is a genomics-based cancer treatment testing company that accelerates access to precision care by combining AI expertise with advanced molecular biopsy solutions. Leveraging AI-based informatics for treatment selection and monitoring, oncologists now have leading clinical decision support right at their fingertips. With a network of over 20 hospitals and reference labs worldwide, ICH ensures that doctors have the right insights to deliver cost-effective cancer testing to patients no matter where they seek treatment. Join ICH in closing the health-equity gap in cancer: imagiacanexiahealth.com
Digital Technology Supercluster Announces Investment to Increase the Effectiveness of Precision Oncology
Harnessing artificial intelligence to take the guesswork out of diagnosing cancer recurrence for millions of cancer survivors
Vancouver, BC [April 21, 2022] – Canada’s Digital Technology Supercluster is excited to be
investing in AI and technology innovation that will advance personalized cancer treatment and
improve patient outcomes. Led by Imagia Canexia Health, in partnership with BC Cancer
Research, DNAstack, Microsoft, Queen’s University and University Health Network, the
CanDETECT project is developing a precision oncology software that will monitor cancer
recovery and recurrence for millions of Canadian cancer survivors.
“Digital healthcare innovations can have a significant positive impact for cancer patients and
their families,” said the Honourable François-Philippe Champagne, Minister of Innovation,
Science and Industry. “By detecting relapse or resistance to therapy early, the CanDETECT
project can help improve patient outcomes, reduce cancer care backlogs and build greater
resiliency across Canada’s healthcare systems. This is one more example of how the Digital
Technology Supercluster and digital innovation can help Canadians and their families during
very difficult times.”
Cancer remains the leading cause of death in Canada, and according to Canadian Cancer
Society nearly half of Canadians are expected to receive a diagnosis of cancer in their lifetime.
The recovery of cancer patients and survivors depends on close monitoring of treatment
response and ensuring recurrence is detected early. However, current approaches are largely
ad-hoc, costly and have a low success rate, providing generic data on the presence of cancer
with no specific treatment guidance. The current ‘one size fits all’ approach limits the chance of
effective treatment and survival.
“The AI-based oncology software being developed and tested as a part of the CanDETECT
project will enable clinicians to perform a real-time assessment of tumor status, detect earlier
signs of patient relapse and recommend alternative treatment options, ensuring the best
possible outcome faster, more accurately and at less cost than current solutions,” said Geralyn
Ochab, CEO of Imagia Canexia Health. “This ‘Made in Canada’ solution will transform cancer
care for Canadians.”
The AI-based oncology software will identify and predict the best available targeted therapies
and/or clinical trials for cancer patients throughout the course of their treatment and will analyze
and track how each patient responds to therapy over time. The consortium will also harness
artificial intelligence, machine learning and big data to better predict patient response to
targeted therapy by integrating and analyzing multimodal patient data.
“The ability to monitor cancer recurrence dynamically means we can offer patients personalized
treatment responsive to the changing biology of their cancer,” said Bill Tam, COO of the Digital
Technology Supercluster. “We are extremely proud of the break-through research and
development happening between Imagia Canexia Health, BC Cancer Research, DNAstack,
Microsoft, Queen’s University and University Health Network. Together we are accelerating
progress against cancer and improving survival outcomes for all Canadians.”
The CanDETECT project has a total investment of $17.8 million, with $12.5 million invested by
industry and $5.3 million co-invested through the Supercluster’s Technology Leadership
program. Other supporting partners involved in this project include Illumina, Kingston General
Health Research Institute and Kingston Health Sciences Centre. More information on
CanDETECT can be found here.
Director, Government Relations & Public Affairs
Canada’s Digital Technology Supercluster
About Canada’s Digital Technology Supercluster
Ahead of the curve starts here. The Digital Supercluster drives digital innovation that is the
foundation of a resilient Canadian economy. We impact the lives of all Canadians through
technology advancements that prioritize environmental sustainability, advance healthcare and
accelerate business transformation and growth. Through a powerful combination of multi-sector
collaboration, industry co-investment, IP creation and digitally skilled talent development, the
Digital Supercluster is helping Canada fight against the pandemic, leverage ‘green’ technologies
to power the economy and improve the health and safety of every Canadian now, and for
generations to follow. Learn more at: www.digitalsupercluster.ca
Imagia Cybernetics & Canexia Health Merge to Supercharge Precision Oncology Accessibility
February 09, 2022 09:00 AM Eastern Standard Time – VANCOUVER, British Columbia & MONTRÉAL–Imagia Cybernetics, an AI-healthcare company that accelerates oncology solutions generated from real world data, today announced its merger with Canexia Health. Canexia is an oncology innovator that streamlines complex cancer genomic information which allows oncologists to identify optimal treatment selection and patient monitoring. The merger includes C$20 million funding with participation from: BDC Capital’s Women in Technology Venture Fund, Desjardins Capital, and PacBridge Capital. Combined, Imagia and Canexia will increase access to precision oncology at the community level. In addition to working with four leading pharmaceutical companies, Imagia and Canexia are integrated with 20 hospital systems and reference labs around the world. Their expertise in genomics, oncology, artificial intelligence, and informatics will enable health systems to bring testing in-house, delivering precision oncology to patients no matter where they live.
While 85 percent of all cancer treatments in the United States are administered at community cancer centers and local hospitals, only 15 percent of patients are routinely screened for targeted treatment selection that can improve outcomes threefold1. The new company, Imagia Canexia Health, improves accessibility through cost-effective local testing, thereby reducing expenses and generating faster results. This integrated solution leverages AI-based informatics for treatment selection, patient monitoring, and provides clinical laboratories support to bring testing in-house. The result is a new ability to integrate patient clinical and genomic data which achieves more effective treatment decisions by oncologists.
“Combating cancer is what Imagia set out to accomplish through advanced AI technology, and merging with Canexia speeds up our momentum to realize that goal,” said Imagia CEO Geralyn Ochab, who will lead the new company. Ochab spent over 20 years on technology’s cutting-edge in healthcare creating durable business partnerships in previous roles at Toshiba, GE Healthcare, and Resonant Medical. During that time, she orchestrated market expansions, built high performance teams, and spearheaded full scale corporate restructures. “Imagia’s EVIDENS platform, with its distributed model providing onco-clinical solutions generated from real world data, is critical to our joint ecosystem’s ability to provide earlier treatment selection and recurrence monitoring.”
Aligning resources, the merger now enables expanded access to precision-guided cancer management. Imagia’s robust data insights technology preserves cancer healthcare data privacy via federated learning and Canexia’s end-to-end solution tests, validates, and delivers the analysis directly to the oncologist. Together, they will provide faster and more comprehensive insights.
“Targeted cancer therapies transform access to cancer treatment, patient outcomes, and health system effectiveness. Through Imagia Canexia Health these precision treatments can be available to physicians and patients around the world,” said Canexia Health Board Chair Sue Paish, who will also chair the new company. “This merger with Imagia will greatly enhance access to life saving cancer treatments and improve health equity.”
“This merger realizes new revenue streams from integrated workflow solutions, and more services that bring therapeutics to where patients need them most,” said Michael Ball, Canexia Health CEO.
“Combining two advanced technology companies to bring affordable access to the best cancer treatments closer to the patient is exactly the kind of opportunity that we want to invest in,” said Michelle Scarborough, a Managing Partner at BDC’s Women in Technology Venture Fund.
The transaction is expected to close at the end of February, subject to shareholder approval.
About Imagia Cybernetics
Imagia, an artificial intelligence and healthcare company, develops digital medical innovations that aim to improve the health of cancer patients and those with other heavy-burden diseases. Through its collaborative ecosystem, Imagia EVIDENS™ enables hospitals, medical device manufacturers, pharmaceutical companies, and diagnostic companies around the world to access and utilize healthcare data while preserving data privacy. Headquartered in Montréal, Imagia’s mission is to unlock the potential of data across all organizations to achieve collaborative, medical breakthroughs. www.imagia.com
About Canexia Health
Canexia Health makes high-quality cancer genomic information accessible and affordable with our clinically-validated assays, informatics, and support. Our suite of genomics-based cancer tests is clinically actionable and cost-effective, designed to improve cancer treatment and monitoring. With our extensive scientific experience, specialized genomics-based tests, and support from pharmaceutical and diagnostic partners, we are leading the shift towards precision oncology. www.canexiahealth.com
1 Gutierrez, Martin E., et al. “Genomic Profiling of Advanced Non–Small Cell Lung Cancer in Community Settings: Gaps and Opportunities.” Clinical Lung Cancer, 13 Apr. 2017, https://www.clinical-lung-cancer.com/article/S1525-7304(17)30109-2/fulltext
White Paper: Lessons learned from a national program to access to cancer testing & treatment during COVID-19
With a strategic investment from Canada’s Digital Technology Supercluster, a pilot project to bring ctDNA testing into the Canadian health system was launched in July 2020. Known as Project ACTT (Access to Cancer Testing & Treatment), the project demonstrated that the ability to conduct ctDNA testing at a local laboratory broadened access to rural and underserved populations, removing geography as a barrier to informed cancer treatment decisions. Such testing also kept high-risk patients out of hospitals and other healthcare settings during COVID-19.
The project’s primary goals were to:
- Enable sustainable funding by generating ctDNA health technology assessment data
- Provide 2,000 liquid biopsy tests to cancer patients between July 2020 – July 2021
- Improve transferable liquid biopsy technology
Key findings specific to ctDNA testing conducted during Project ACTT, as well as recommendations for replication in other locales, are summarized below.
Real world data
During Project ACTT, Canexia Health’s liquid biopsy assay, Follow It(R), was used for testing for patients with advanced colorectal, lung and breast cancers. Follow It analyzes ctDNA in plasma isolated from peripheral blood, focusing on clinically actionable sensitizing and resistance mutations within a carefully selected set of hotspots.
The version of Follow It deployed during the project targeted 30 genes most relevant for selection of treatment, providing a robust and cost-effective solution for clinical molecular testing with a short turnaround time from sample receipt in Canexia’s lab to clinical report (approximately 7 business days).
Oncologists overwhelmingly responded to the pilot project, with an 80 percent adoption rate among solid tumor oncologists working in more than 100 institutions. The project reached patients in 12 provinces and territories, and exceeded its target of reaching patients in remote and rural areas, with 11 percent of samples received outside of major urban centers.
- The overall success rate of blood sample testing was high: 99.3 percent of samples that arrived at Canexia’s lab were viable for testing.
- Within the project’s three cancer types (breast, lung, colorectal), in ∼50 percent of cases, one or more mutations were identified, reflecting published frequencies of detectable mutations in plasma of these patients.
- The spectrum of detected mutations included both frequently mutated genes in respective cancer types (such as PIK3CA in breast, EGFR in lung and KRAS in colorectal), as well as many other less frequently altered genes.
- Approximately 37 percent of mutation-positive cases received recommendations regarding FDA approved Tier I/II targeted treatments, such as EGFR inhibitors in lung cancer, and panitumumab and cetuximab in colorectal cancer based on KRAS mutation status.
Recommendations for replication
Project ACTT demonstrated that innovation in cancer testing can minimize the collateral damage of COVID-19 on cancer patients. However, this innovation should not be considered a one-off in response to a single crisis, but rather, a long-term solution that can be adopted as standard of care anywhere in the world.
Recommendations to replicate such an initiative within a national health system include recruiting a strong network of ecosystem partners, identifying the data required to make the clinical and health economics case for reimbursement for ctDNA testing, and educating key stakeholders early in the program – especially oncologists and patient advocacy groups.
For additional findings and recommendations, download the paper.
White Paper: Best Practices for Bringing Liquid Plasma Biopsy In-house
Liquid biopsy is a powerful tool for matching cancer patients with targeted therapies and for cancer recurrence monitoring. Currently, most liquid biopsy testing is conducted by sending patient samples to a third party. Test send-out can be more costly and less efficient compared to conducting liquid biopsy in-house within a hospital, health system, or cancer center laboratory.
In a new white paper, we share considerations for labs interested in bringing liquid biopsy testing in-house, including how liquid biopsy compares to tissue biopsy, appropriate use cases for liquid biopsy, and factors including sample collection, staffing, and clinical reporting.
The paper draws from first-hand experience in the CLIA, CAP, and DAP-accredited lab at Canexia Health, and is based on a webinar hosted by The Pathologist in September 2021 by Dr. Melissa McConechy, Senior Manager of Assay Development at Canexia.
While liquid biopsy testing is not new technology, mass adoption within hospital and health system clinical molecular labs is progressing incrementally. In the meantime, there is a significant gap in access for patients where there is a need to identify molecular biomarkers to help with therapeutic decision-making.
Closing this gap is critical for optimal patient care and outcomes, and bringing testing in-house is one way to address this challenge.
Download the white paper here.
To watch the webinar on the same topic, visit here.
CBCN White Paper: Considering Canada’s Approach to Precision Oncology
The use of genomic profiling and testing in cancer is helping clinicians and patients better understand the key drivers of a patient’s tumour and inform more precise treatment decisions.
However, while many centres in Canada are currently using genomic profiling for cancer, there is no defined national process to guide its wide scale use and funding. Given certain therapies require confirmation of a biomarker, there are also concerns about equitable access to testing, as well as testing turnaround times. In some instances, it can take weeks to months for results to be returned. The lack of a clear framework around when and who should be tested is generating many questions amongst patients and clinicians.
To help understand the different perspectives and values on precision oncology in breast cancer and the role of testing and data, the Canadian Breast Cancer Network (CBCN) recently published the white paper, Precision Oncology and Breast Cancer: Considering Canada’s Approach in an Evolving Landscape, which shares observations and key takeaways based on interviews with patients and physicians.
- A national testing framework to guide and support a stepwise approach to genomic testing for cancer patients and reimbursement for these tests.
- Accelerated reviews to adapt the current approval and funding process for innovative therapies that demonstrate large potential magnitude for benefit.
- Educational resources including making more widely available and accessible patient resources about precision oncology testing and treatment.
To read more, download the report from CBCN here.
Lab Genomics Announces MolDX® Coverage for Follow It® Circulating Tumor DNA Assay in Partnership with Canexia Health
FOUNTAIN VALLEY, Calif. & VANCOUVER, British Columbia – November 1, 2021 – Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California and other US locations, today announced in partnership with Canexia Health that MolDX has finalized coverage determination under the policy “Plasma-Based Genomic Profiling in Solid Tumors” for Follow It, a circulating tumor DNA (ctDNA) assay. The coverage decision provides Medicare reimbursement for Follow It for use in breast, lung, and colorectal cancers.
Follow It, which requires only a simple blood draw from patients, analyzes ctDNA in plasma to evaluate somatic mutations in 337 hotspots and 26 exons in 38 cancer associated genes. This information can be used to guide targeted treatment selection, which has been shown to improve patient outcomes up to threefold.
“Medicare coverage for liquid biopsy is a critical step in helping cancer patients gain access to targeted therapies,” said Leena Dalal, Founder of Lab Genomics. “We commend MolDX for this decision that supports our focus on delivering individualized medical care.”
“Reimbursement for Follow It greatly expands access to a minimally-invasive test for cancer treatment selection for some of the most prevalent forms of solid tumor cancer,” said Michael Ball, CEO of Canexia Health. “This MolDX decision marks a significant milestone in our mission to transform cancer care.”
About Canexia Health
Canexia Health makes high-quality cancer genomic information accessible and affordable with our clinically-validated assays, informatics, and support. Our suite of genomics-based cancer tests is clinically actionable and cost-effective, designed to improve cancer treatment and monitoring. With our extensive scientific experience, specialized genomics-based tests, and support from pharmaceutical and diagnostic partners, we are leading the shift towards precision oncology.
About Lab Genomics
Lab Genomics, LLC was cultivated with the ideal in mind of providing state of the art molecular genetic testing with the end goal of the best quality of life possible for the patient. Lab Genomics is focused on delivering individualized medical care through its robust molecular and genetics diagnostics. The Lab Genomics team are highly qualified experts in the medical and genetics fields.
OncoHelix and Canexia Health Enter Partnership to Offer Precision Oncology Genomic Testing to Canadians
Two Canadian innovative genomics diagnostic companies, OncoHelix and Canexia Health, are partnering to help Canadian cancer patients gain access to precision genomic testing via their oncologist. Using a circulating tumour DNA (ctDNA) or “liquid biopsy” blood sample, the partnership allows for Canexia Health’s Follow It® ctDNA 38-gene panel to be accessed through OncoHelix for testing services at HTL lab, a clinically accredited, Canadian-based, genome diagnostics lab that can support test requests for all provinces in Canada. This is one of the first opportunities where Canadians have an alternative choice to out-of-country ctDNA cancer genomics panel and lab testing service providers.
Filomena Servidio-Italiano, President and CEO of Colorectal Cancer Resource & Action Network comments on what it will mean to have ctDNA genomic profiling available in Canada: “ctDNA results facilitated by OncoHelix using the Follow It panel can provide much needed insight for both patients and clinicians, giving way to the opportunity for personalizing treatment and ultimately improved patient outcomes. We encourage all Canadians diagnosed with metastatic colorectal cancer to speak to their treating oncologist about undergoing biomarker testing early on in their treatment journey to help inform treatment decisions.”
“Targeted cancer treatments can dramatically improve patient outcomes,” said Michael Ball, CEO of Canexia Health. “Follow It is focused on such actionable results, including biomarkers associated with response to FDA and Health Canada approved therapies, as well as current Canadian clinical trials. We are pleased to offer Follow It through this collaboration with OncoHelix to provide Canadian cancer patients with a minimally invasive option for biomarker testing for multiple cancer types.”
The partnership between Canexia Health and OncoHelix will launch the Follow It® ctDNA panel in late September 2021 to all Canadian provinces. Requisition forms from oncologists will be accepted starting September 15, 2021 and can be found on the OncoHelix website at www.oncohelix.org.
OncoHelix’s mission is to facilitate exceptional clinical-grade molecular and immune profile testing for diagnostic, research, clinical trials and clinical use for patients and their oncologists. Based out of Calgary, Alberta Canada, OncoHelix works with health industry, patients and their oncologists to make cancer genomics and immune profiling accessible across all provinces in Canada and countries world-wide. OncoHelix is specialized in providing top line testing services with innovative panels, via a partnership with HTL Lab located within the University of Calgary.
Canexia Health makes high-quality genomic information accessible and affordable to support cancer treatment selection and monitoring. Our oncology software platform and clinical services enable actionable, cost-effective, and fast interpretation for next-generation sequencing assays. Together with healthcare and diagnostic partners, we are leading the shift towards precision oncology.
For more information, please contact:
Shaniah Leduc | Director, Business Development
Jennifer Temple | Head of Communications
GenomeWeb Features Canexia Collaboration with Sutter Health to Expand Access to Precision Oncology
An in-depth article in GenomeWeb highlights Sutter Health’s work with Canexia to assess if a “triaged, in-house testing strategy improves outcomes, lowers cost, and reduces access inequities.”
“While most organizations are still outsourcing NGS testing, health institutions are increasingly implementing local testing strategies. In a 2019 precision oncology survey of oncologists and pathologists conducted by Novartis, 83 percent said their organizations send out NGS testing to third-party labs. However, there was a 58 percent increase from 2018 to 2019 in respondents reporting they had in-house NGS testing. Faster turnaround time and better management of patients’ data were among the top advantages cited for in-house NGS testing.”
“An internal testing strategy can also help improve access to clinical trials, which are a big part of precision oncology programs but tend not to be broadly accessible within community practices where most patients get treated. With in-house testing, the institution maintains and manages patients’ samples, which also bolsters an institution’s ability to do research using patients’ biomarker data.”
“For both Canexia and Sutter, there is also a health equity element to all this. Studies continue to show that despite greater availability of FDA-approved precision oncology treatments in recent years and exponential growth within the genetic testing industry, not all cancer patients are benefitting from these advances.”