By Dan Rhodes
February 3, 2021 | The term “comprehensive genomic profiling” (CGP) refers to a test methodology that uses next-generation sequencing to simultaneously assess the four main classes of genomic alterations that may be responsible for driving cancer growth. This type of testing represents a significant advance from single gene testing that detects alterations in only one gene, potentially missing clinically relevant mutations in other genes.
With the increasing number of FDA-approved targeted therapies and immunotherapies, CGP is becoming a standard diagnostic tool for patients with cancer. Since 2014, one in four new therapies approved by the US Food and Drug Administration (FDA) has been a personalized medicine. Additionally, the FDA continues to approve new molecular indications for existing personalized therapies.
A major advantage of CGP lies in its comprehensive nature, or ability to simultaneously detect hundreds of cancer-associated genes. Traditional testing strategies have consisted of a sequence of single gene tests, or sequential testing, to determine if a patient may benefit from targeted therapy. CGP ensures a patient’s tumor is assessed for all clinically relevant genomic alterations, including histology-agnostic biomarkers and biomarkers that may help direct patients to appropriate clinical trials. CGP also presents an opportunity to eliminate workflow inefficiency, reduce the need to re-biopsy, and save valuable time to treatment decisions.
Even as CGP becomes the standard of care in oncology, several barriers prevent access to patients with cancer. In fact, some estimate that only 15%-20% of patients with advanced cancer receive CGP.
One hurdle to access is widespread implementation of CGP across a health system. Investigators at Kaiser Permanente Northern California published an abstract at the American Society of Clinical Oncology (ASCO) 2020 Digital Annual Meeting showing how they implemented a large-scale genomic oncology program, which “allowed for greater adoption of routine NGS testing, especially for rare cancer types with less effective standard treatment options available.” In this study, 39% of patients had an actionable mutation and nearly 22% qualified for a promising clinical trial. These findings demonstrate that an enterprise level approach can facilitate routine CGP and identify more treatment options for patients with cancer.
Another major impediment to widespread testing is availability of sufficient tumor tissue. Our team at Strata Oncology presented a study at ASCO 2020 that showed fewer than half of >20,000 consecutive tumor tissue samples met tumor surface area requirements for leading commercial hybrid-capture CGP tests. This study was conducted across twenty-five diverse health systems and suggests that greater than 50% of patients with advanced cancer may not have enough tissue for several leading commercial CGP tests. While liquid biopsy is becoming a valuable option for cancer management, tumor tissue remains the gold standard.
We can only deliver on the promise of precision medicine through widespread and routine access to CGP for all patients with cancer. It is incumbent on us to ensure CGP is comprehensive not only by virtue of the thoroughness of its assessment of cancer-associated genes, but also by enabling access at scale through comprehensive testing programs and by providing test results for patients regardless of tumor tissue quantity.
Dan Rhodes is CEO and co-founder of Strata Oncology, a precision oncology company advancing molecular indications for cancer therapies. Strata Oncology is dedicated to delivering the best possible treatment for each patient with cancer. The company combines molecular profiling, real-world data, and a large-scale clinical trial platform to identify and deliver optimal treatments for patients with cancer. He can be reached at dan@strataoncology.com.