Precision medicine -- medical care designed to optimize efficiency or therapeutic benefit for particular individuals or groups of patients, especially by using genetic or molecular profiling – has begun to revolutionize the way doctors predict and prevent disease, treat cancer and rare pediatric conditions, cardiovascular, pulmonary and renal diseases, and even non-invasive pre-natal care.
Guess what happens when Pharma select patients for Phase 1 cancer drug trials that are actually molecular matches to the drug they’re trying to test? A study published by the Journal of the American Medical Association in November 2016 looked at results for more than 13,000 cancer patients in 346 Phase 1 clinical trials. Its conclusion: that patients receiving biomarker-based treatment and therapy had a response rate (the percentage of patients whose cancer shrinks or disappears after treatment) six times higher than patients receiving standard (surgical, chemo and radiation therapy) care.
In a world where, for the first time in human history, there are now more people over 60 than under five years old – the mainstreaming of precision medicine will rank with the discovery of antibiotics as one of the biggest medical breakthroughs -- ever.
In 2003, scientists mapped the human genome for the first time. It’s now possible to map an individual human genome – or the genome of a medical sample, such as a tissue biopsy -- for about a thousand dollars, in less than a day. Once the results are analyzed, clinicians gain unprecedented insight into what’s fueling a patient’s medical condition, as well as the ability to target therapies precisely, less toxically, and measurably more successfully.
From a competitive perspective, patients are beginning to wake up to this new reality and demand a higher standard of care. I travel a lot, visiting newsstands before I board flights and invariably at least one magazine will have this topic featured on the cover. At the recent American Society of Clinical Oncology (ASCO) conference, news of a new targeted cancer drug called ‘larotrectinib’ from Loxo Oncology demonstrated a durable response of over a year for 80 percent of advanced cancer patients with TRK mutations who were ‘molecular matches’ for this drug. In late May, the FDA approved Merck’s immunotherapy drug Keytruda to treat tumors with genetic defects known as “microsatellite instability” or “mismatch repair” deficiencies, the first time the agency has cleared a cancer drug for use not tied to the original site of a tumor. However, the reality, for the vast majority of doctors practicing today, is that genome-based diagnosis and treatment was not a part of their medical school curriculum. The challenge for the medical informatics industry is to make precision medicine easier to use by integrating genomic data into the Electronic Medical Record, and by creating visualization tools that can analyze genomic data and produce reports doctors can easily understand and use.
How to Prepare
Hospital CIOs looking to get ahead of the precision medicine curve have a range of options. Larger hospitals are beginning to invest in the capabilities to deliver a precision medicine workflow themselves, from sample prep, sequencing, analytics, and clinical interpretation in order to offer a precision diagnosis and treatment plan for their patients. These larger hospitals are adopting solutions, readily available from vendors ranging from Dell to HP to Lenovo among others, which will allow them to do genomic analysis in-house. These systems are scalable enough to allow hospitals to apply bioinformatics at low cost and predictable throughput, generating genomics-guided diagnostic data being able to plug that into any point of care solution that they prefer. Smaller hospitals can choose to outsource the precision diagnostic and treatment planning capabilities to commercial diagnostic labs. Foundation Medicine, a major precision medical diagnostics provider, can map the original sample, conduct secondary analysis, and provide clinicians with a report identifying mutations and recommending the most efficacious drugs and clinical trials.
I know about the promise of this game-changing technology – in March 2014, I was diagnosed with one of the most advanced and aggressive prostate cancers the doctors at Oregon Health Sciences University had ever seen. Surgery and chemotherapy failed to stop the progress of the disease. It spread to my bones, and by early 2015, published data was pointing to a median survival for someone in my situation of 21 months.
Fortunately, OHSU took it upon itself to genetically sequence my tumor. It showed clinically significant mutations that allowed my doctors to identify what factors were causing it to grow. With that data, they helped me get into a clinical trial of a drug that could target those mutations, and it shut down the unique way this cancer was growing. It worked for two years. An exceptional response by any definition.
Intel and is working closely with health informatics industry partners to increase the point-of-care utility and reduce total cost of ownership of genomics analytics solutions. Intel has developed scalable reference architecture including integrated compute, fabric, and storage components that significantly increase sequencing data processing speed and scalability, reducing the “time to insight” in research and the “time to answer” for medical institutions.
Precision medicine isn’t science fiction – it’s real, today. For hospital CIOs, the question isn’t whether genomics-based precision medicine should be a part of their therapeutic menu – it’s when, and how.
What questions do you have about precision medicine? How can Intel help?