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Clinical Laboratories and Pathology Groups

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Some cancer researchers worry that these patients may not benefit from such clinical laboratory testing because effective therapeutic drugs don’t exist for their cancers

What can be more patient-centric than for a medical laboratory company to offer free genetic tests for cancer? That’s the strategy of a firm in Canada that is offering free cancer genomics testing to 1,500 cancer patients. However, some cancer researchers responded to this offer with skepticism.

In March, Contextual Genomics of Vancouver, British Columbia, began providing its cancer genomics test free to the first 1,500 patients whose oncologists submitted tumor samples. These specimens would be tested using the company’s Find It hotspot cancer panel.

“You could call it marketing, but it’s making this test available to people who haven’t had access to it before,” stated Chris Wagner, Contextual Genomics President and CEO, in a CBC News Canada interview.

Contextual Genomics says its Find It test focuses on “90 hotspots across 29 known cancer genes and analyzes seven exons of three genes,” with the specific genes and mutations selected because they are “actionable and can potentially direct patient treatment, indicate prognosis, and support diagnosis.” Oncologists that participate in this commercial pilot program will receive a comprehensive report that interprets the sequencing results. The report also identifies any approved drugs or clinical trials that target the patient’s gene mutations.

Free Test Raises Concerns

David Huntsman, MD, FRCPC, FCCMG, Chief Medical Officer of Contextual Genomics, believes personalized medicine is the future of cancer care and that his company’s Find-It test will help patients make appropriate treatment decisions.

“The essence of personalized cancer care can be distilled into the right treatment for the right patient at the right time, and our test will help patients and oncologists determine what is the best option,” he stated in a CTV News interview.

The company’s free-testing initiative, however, is not receiving universal praise.

Daniel Rayson, MD, FRCPC, is Medical Oncologist and the QEII Health Centre Cancer Care Program and Director, for the Atlantic Clinical Cancer Research Unit at Capital Health. He appreciates the marketing value of Contextual Genomics’ announcement, but questions whether patients will receive the value they expect from the results of the genetic test.

“My concern is that offering them for free sounds fantastic. Who wouldn’t want it,” Rayson said in the CBC News Canada interview. “It is a shrewd and strategic business move to create an appetite for something that sounds wonderful. But whether it can deliver is still something that has to be established worldwide.”

Free Test Could Raise False Hopes

In theory, drug therapy can be targeted at a specific genetic marker, but Rayson adds, “Just finding the marker doesn’t mean the drug actually works for the patient. It creates an unrealistic picture.”

Suzanne Kamel-Reid, PhD, FACMG, Director of the Advanced Molecular Diagnostics Laboratory at Princess Margaret Cancer Centre in Toronto, warns it may not yet be possible to match most cancer mutations to specific drug therapies. “We can find mutations, but there aren’t actual drugs that can target most of those mutations,” Kamel-Reid stated to CBC Canada. “So, at the end of the day, when you try to match drugs to targets, really only 5% of the current targets are drugable. And it’s really only because of the lack of drugs out there.”

Dr. Suzanne Kamel-Reid (above center), directs the Advanced Molecular Diagnostics Laboratory (AMDL) at the Princess Margaret Cancer Centre. AMDL is a CAP/CLIA-certified clinical laboratory that develops, evaluates and implements innovative high complexity molecular diagnostic clinical tests for Princess Margaret Cancer Centre clinical programs. (Photo and caption copyright: UHN Princess Margaret Cancer Center.)

Dr. Suzanne Kamel-Reid (above center), directs the Advanced Molecular Diagnostics Laboratory (AMDL) at the Princess Margaret Cancer Centre. AMDL is a CAP/CLIA-certified clinical laboratory that develops, evaluates and implements innovative high complexity molecular diagnostic clinical tests for Princess Margaret Cancer Centre clinical programs. (Photo and caption copyright: UHN Princess Margaret Cancer Center.)

Kamel-Reid also fears people may be led to believe that all cancer patients are candidates for gene testing.

“You don’t want to raise false hope, and I think it’s really important to make sure the right patient population is tested,” she added. “So, you don’t want the marketing to go out there and for patients to be feeling like they’re missing out on something or they’re not getting the right treatment because they’re not getting this testing. Because it may not be appropriate for them.”

Doctors Might Be Reluctant to Order Free Test

Steven Narod, MD, FRCPC, FRSC, is a Senior Scientist at Toronto’s Women’s College Research Institute and Director of the institute’s Familial Breast Cancer Research Unit. He expressed concern that Contextual Genomics may be ahead of its time in offering physicians a commercial genomic testing product.

“Linking mutated genes and a list of drugs that might attack that specific cancer with the goal of extending life is still considered experimental,” Narod said in the CTV News Canada article. “I think most cancer doctors will be reluctant to order [the test] because they will have difficulty interpreting the results.”

Wagner, however, argues that healthcare needs to keep pace with innovation and provide patients with access to cutting-edge diagnostics and drug therapies.

“There is always a push and pull between new innovation and the system’s willingness to adopt this, and it’s particularly true in medicine,” Wagner said in the CBC Canada article. “We’ve gone from zero to where we are now in probably under 10 years. And we’ve made an incredible amount of progress, so it is moving more quickly than most innovations happen. But it’s not moving inappropriately fast. These are treatments and diagnostics that benefit patients today. And patients should have access to it.”

Huntsman also believes genomics cancer testing will provide doctors with valuable information that can guide treatment decisions.

Contextual Genomics is launching the initiative as part of Canada’s National Access Program for Cancer Testing, which is managed by the Personalized Medicine Initiative. Funding and technical assistance also are being provided by:

Archer;

AstraZeneca;

Illumina;

LifeLabs;

Pfizer; and

Sanofi.

At the conclusion of Phase 2 testing of the Find It panel, Contextual Genomics is expected to sell the commercial test for less than $1,000.

“Contextual Genomics’ assays are designed to find the mutational information that oncologists and their patients need to make appropriate treatment decisions,” Huntsman said in a news release. “Treatments are being developed which focus on specific abnormalities and the Find It genomics test provides a breadth of valuable data which will help to determine if a patient will respond and benefit from a specific treatment.”

Clinical laboratory executives and managers may be intrigued by one aspect of Contextual Genomics’ giveaway of an expensive genetic test to the first 1,500 patients. Canada has a universal healthcare system. Each provincial health authority must make a decision to cover new diagnostic tests. Thus, this genetic testing company probably considers it can build support among patients for positive coverage decisions by offering its genetic test for cancer at no charge to this first group of patients.

—Andrea Downing Peck

Related Information:

Contextual Genomics and the Personalized Medicine Initiative Launch Phase 2 Testing of its National Access Program Cancer Genomic Test

Free Cancer Tumour Gene Screening Raises Eyebrows

Vancouver Company Offers Free Gene Analysis for Cancer Patients

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