Barriers to genomic testing get in the way of precision medicine

This opinion article was originally published at STAT news.


As precision medicine opens up promising new advances in cancer care, I often think back to my early days as an oncologist, the patients I treated, and the limited treatment options I had for them.

I especially remember Pam (not her real name). She was in her early 30s, recently married, vibrant, and looking forward to a life filled with joy and children. Pam had acute myeloid leukemia, a disease oncologists had struggled to treat for decades. Her leukemia was relentless: Chemotherapy did little to stop it, and it persisted even when we tried a stem cell transplant. Pam died a year after her diagnosis.

Although that was more than a decade ago, her case is still fresh in my mind. It grew fresher last year when four therapies were approved specifically for acute myeloid leukemia, several of which target the molecular underpinnings of this disease. These therapies don’t work for everyone, but for those with the right molecular profile, they offer a better chance of controlling this cancer. I’ll never know if any of these new therapies could have saved Pam, but I would have wanted the opportunity to offer them to her.

Today, in my role as chief medical officer at Cardinal Health Specialty Solutions, I have the unique opportunity to work with thousands of oncologists across the country. Time and time again I hear their excitement about the new precision oncology medicines that are coming to market and the possibility of providing better outcomes to their patients.

Yet Even As Innovative Targeted Therapies Become Available, Various Barriers Prevent Patients From Gaining Access To Them. One Hurdle That Surprised Me Is Access To Genomic And Mutational Tests.

These are used to identify genetic abnormalities that may be responsible for driving cancer growth. Thanks to these tests, oncologists can identify patients with specific genetic abnormalities who have the greatest likelihood of responding to targeted medicines. Yet with thousands of tests available, the process of selecting and choosing the right one can be challenging.

Our team at Cardinal Health surveyed more than 160 oncologists to better understand their perceptions and concerns about precision medicine and genomic testing. Although 65 percent of the respondents said they routinely used genomic testing to determine the best therapy for their patients, many said they worry about their ability to order these tests efficiently and in a timely manner. Nearly 60 percent reported that such testing is not available at their institution and samples for testing must be sent out. In most hospitals, this happens in batches once or twice a week, which adds an extra delay. One-third of respondents said they wait 15 days or more to receive test results.

Most of those surveyed reported that their patients’ health insurance companies must pre-approve tests before they are ordered, otherwise the entire cost would be the patient’s responsibility. That adds to the delay in getting results.

Waiting several weeks for test results may not seem like a big deal, but for patients with an advanced cancer, every day can make a difference.

Our research identified another impediment to using genomic testing: difficulty understanding the test results. Nearly 60 percent of the oncologists we surveyed said that a key reason they did not use genomic tests is that the results are often difficult to interpret. A variety of factors may contribute to that, including the number of different tests, conflicting results when tests are performed by different vendors, and the overall lack of experience oncologists have reading test results.NEWSLETTERS

Most oncologists are deeply committed to providing the best care for their patients. But they are also stretched for time and often overloaded with administrative work. If the process of testing patients for genetic mutations is too burdensome, they may opt for a simpler and more familiar course of treatment and, as a result, their patients may miss the opportunity to receive the most advanced care.

Surmounting barriers to genomic testing will require engagement from everyone involved in caring for patients. Diagnostic companies, along with companies that make cancer drugs, need to make tests easier to interpret and teach physicians how to interpret them. Regulators need to set clearer guidelines for tests to ensure greater consistency and ease of use across the industry. They should also require test developers to demonstrate their effectiveness once they are broadly used after Food and Drug Administration approval. Hospital systems need to invest in staffing and training their pathology teams to ensure they are up to date as more tests and therapies come onto the market.

Physicians who treat cancer face abundant challenges. As was the case when I was treating Pam, some setbacks are beyond our control. The logistics of ordering genomic tests and the turnaround time for them, however, are very much under our control. To help our patients, the oncology community must think collectively and creatively about how to overcome these predictable barriers.

Assuring that genomic tests are carried out and properly interpreted in a timely manner is essential to make sure that all patients who can benefit from newer precision oncology therapies have the opportunity to take advantage of them.