Robert Fraser, Ph.D. COO Personalized Medicine Initiative
David Huntsman, M.D. Chief Medical Officer Contextual Genomics
A significant step toward personalized cancer care.
With unprecedented scientific advances over the last decade in genome sequencing, we now have an opportunity to make genomics testing a standard practice in cancer care. The valuable genetic information that genome sequencing can deliver will alter the future of cancer care from the current singular treatment approach toward tailoring treatment to more precisely match a patient’s genomic profile.
The National Access Project for Cancer Testing, managed by the Personalized Medicine Initiative with testing provided by Contextual Genomics,
is designed to drive and facilitate a paradigm shift toward personalized cancer care in which medication selection will be selected on the basis of a patient’s genetic tumor profile. Physicians, patients, pharmaceutical companies, payers, and healthcare systems are advocating for personalized medicine because there’s no question of the benefits it will bring to healthcare. What we will gain from this tailored treatment approach is better health outcomes, reduced adverse drug reactions, patient empowerment, and a major cost-savings on health care systems.
Better Health Outcomes
It’s estimated that more than 50% of prescribed drugs don’t work on patients they are prescribed for due to genetic diversity. In North America, an estimated two million serious adverse drug reactions occurr annually, resulting in more than 100,000 deaths, the fourth leading cause of death. In cancer, it’s estimated only 25% of drugs are effective for the patients receiving them.
Knowing the genetic make-up of an individual gives oncologists the insight needed to guide treatment options based on a patient’s genetic profile. This individualized approach will optimize effectiveness of treatments and greatly reduce serious adverse drug reactions.
Genomics testing will expand the capacity of physicians to provide optimal prevention, diagnostic, and treatment strategies to fit their patients’ needs. All of these fundamental changes will lead to improved outcomes for patients and ultimately improved cost effectiveness for health systems.
Consumer demand is driving the acceleration toward personalized medicine. Undoubtedly, social media and wide access to information has empowered patients to research all available treatment options and to take control of the management of their healthcare. This places higher expectations on physicians to understand the molecular depth of diseases and the broad range of treatment options available.
Patients are aware that genomics testing can strongly support better health outcomes and, justifiably, patients expect access to these tests. Obtaining results from a genetic cancer test empowers patients in the management of their cancer and also provides answers to familial cancer risks.
Integration of Genomics Testing into Standard Practice
Since the completion of the Human Genome Project and the emergence of next generation sequencing (NGS) technology, DNA sequencing has become faster, more accurate, and exponentially cheaper. We believe that genomics testing will become a first-line approach in cancer care and will eliminate the guesswork in treatment options. It’s not a matter of if, it’s a matter of when and how genomics testing will be integrated into cancer care.
Traditionally, cancer diagnosis and treatment are determined by the location of the cancer and its physiological properties. However, many subtypes of cancers are not detected by current standard cancer testing. Without an in-depth analysis a patient’s genetic tumor profile, oncologists prescribe standard treatment based on the location of the tumor. Treatments may not work and may cause discomfort. More importantly, critical time may be lost during this trial-and-error treatment approach.
An individualized approach gives a patient the best shot possible at fighting the cancer. Oncologists can make informed treatment decisions and precisely and quickly address the cancer with the best medication possible based on the genes causing the cancer.
Launch of National Access Project Underway
The National Access Project is set to launch this December. The program will provide a 90-mutation cancer genomics test for 2,000 cancer patients free of charge in ten centers across Canada. As part of the program, we will receive direct feedback from patients and oncologists and will be able to refine our reports and testing based on that feedback. We estimate the commercial version of the test will be available to all Canadians in March 2015.
The National Access Project addresses a number of factors we believe will be necessary for the successful implementation of genomics testing into standard practice for cancer care:
- Tests must be actionable
- Information must be interpreted in a meaningful way to the patient and oncology team
- Tests must be affordable and scalable
- Tests must be accessible by everyone
- Quality assurance is imperative
The National Access Project’s genomics test is a panel identifying 90 known cancer mutations. Each identified mutation is treatable with current medications or Phase III investigational treatments.
Currently, the availability of drugs and those who would most benefit from them is disjointed. As part of the National Access Project, a consortium of oncologists, researchers, pharmaceutical companies, and cancer agencies were brought together to provide input as to which mutations should be contained in the test. Understanding a patient’s genetic tumor profile will leverage the pharmacogenomic information currently available on more than 100 drug labels and will better match a patient to the most effective treatment option.
If you’re a researcher, you can never have enough data, but this approach in clinical care is costly and inefficient. A differentiating feature of The National Access Project’s reports will be the rapid turnaround and web of quality data that will be relevant for patients and their oncologists. Input has been sought to ensure the reports meet the needs of a broad range of practitioners. Physicians and patients will also have access to reports in real-time enabling them to make treatment decisions early.
Test Developed for Reimbursement
Next-generation sequencing technology has dramatically driven down sequencing costs and improved the accuracy of the information. By seeking input from oncologists, researchers, pharmaceutical companies, and cancer agencies, we ensured our test was relevant, actionable, and not over-engineered. We call this the “Honda approach” versus the “Cadillac plan.” The Honda approach gives you what you need at an affordable price. The focused approach creates high value for cost and is attractive to payers considering reimbursement.
Removing Geography as a Barrier
In North America, genomic testing is mainly provided by a variety of academic laboratories, limiting access to only a small percentage of cancer patients. Due to inequitable access and inconsistency in care, most patients go untested and therefore receive trial-and-error or singular treatment approaches, missing out on an opportunity for precise personalized care with targeted medicines. The National Access Project will lead to genomic testing being available to anyone in Canada regardless of where they live. This level of access will also provide the scale to further drive down the costs.
We have established what we feel is a best-in-class quality assurance program. Our quality assurance covers sample identity from sample receipt through report generation and will determine if there are mutations that are not being detected (false negatives) and will also determine if DNA samples are of sufficient quality to be tested.
Complex, multifaceted diseases cannot be treated with generic approaches applied equally across populations. The National Access Project for Cancer Testing is a significant step forward toward personalized medicine in cancer care. This will change clinical practice from a one-size-fits-all approach to precisely matching patients to the treatments that would most benefit them. Genomics testing will pave the way for personalized medicine and ultimately improve the health outcomes for patients and significantly reduce the financial strain on medical systems.
Rob Fraser, Ph.D., is COO at the Personalized Medicine Initiative ([email protected]), and David Huntsman, M.D., is Chief Medical Officer at Contextual Genomics.
This article appears in the December 10 issue of Clinical OMICs. For more content like this and details on how to get a free subscription to this digital publication, go to www.clinicalomics.com.