More Effort Needed to Understand Value Breadth of Molecular Testing

Catherine Tsien Swick

Molecular testing has become an important tool for oncologists.

It provides genomic information unattainable by other testing methods, which makes it a driving force behind the trend toward precision medicine. As the use of testing increases, so does the importance of understanding exactly what it can do for your patients and how to get the most out of the results. Here are five easy ways to make sure you’re getting the most benefit for your patients.

1. Order the right test.

There are hundreds of molecular tests currently available for clinical use in oncology. Most of these tests are for diagnosing a certain type of cancer or classifying the type of tumor, but the number of tests for disease monitoring or determining treatment strategies is rapidly increasing.

Like imaging exams, molecular diagnostic tests are tools to give physicians information, but not all tests are interchangeable. Just as different types of imaging exams have different clinical applications, the same is true for molecular testing. It’s crucial to understand what information each test provides so that you order the correct test.

Two of the most common types of testing technologies are polymerase chain reaction (PCR) and fluorescence in situ hybridization (FISH). Each uses a different technique and has many variants that are used for different purposes. Some labs only offer one technology, while others offer multiple types; the important thing is to make sure the lab is using the right technique for the right purpose. Increasingly, labs are using next generation sequencing technology to sequence millions or billions of DNA strands in parallel. This has allowed for faster and broader gene sequencing, which has sped up the pace of discovery in oncology and the number of treatment options available to patients.

Lori C. Brisbin

We are beginning to see a focused effort by oncology experts to formalize guidelines on the use of molecular testing for various types of cancer. These guidelines will address when tests should be performed, which testing method should be used, and what type of sample should be utilized.

2. Order only what your patients need.

In addition to understanding the technologies employed in the different tests, it’s also important to understand the scope of the test you are ordering. Some tests are focused and provide targeted analysis on a very specific gene or set of genes. Other tests offer whole genome sequencing and can detect all four main types of gene alterations and provide a comprehensive analysis of the 20,000+ genes in the human genome.

While the idea of receiving comprehensive genomic information sounds great, ordering a test that gives you more information than you need can have negative consequences. For example, the patient’s insurance provider may consider this level of testing unnecessary and not reimburse the lab for the added expense of the extensive testing, which can leave your patient with significant out-of-pocket expenses. Too much information may also “muddy the waters” in terms of providing a clear diagnosis or treatment recommendation.

3. Provide complete information to the lab.

It may sound simple, but you’d be surprised at how many physicians’ offices order tests without providing the complete information about the patient for whom the test is being ordered. Without access to the indication, patient’s age, gender, race and family history, a lab cannot provide an accurate interpretation of the test.

Whether laboratory testing is ordered by the oncologist or someone else in the practice, it is essential to provide complete information about the patient’s clinical findings and background with the order. If complete information is not provided, someone at the lab should follow-up to collect this information before testing begins.

4. Understand the results.

You should expect to receive accurate, reliable and timely results from CLIA-certified labs. But it’s also important to consider how the results are provided and work with labs that provide them in a manner that is beneficial to your practice and your patient.

For example, does your lab send results in a paper format or electronically for easy input into your patient’s electronic health record? From a practice management perspective, the last thing you want is to slow down the flow of information or add steps to your workflow by having to manually input data. Not only does this create inefficiencies, but any time information is manually entered, it increases the chance for errors.

The other consideration is what information is provided on the report. Lab reports should provide more than just raw data, which can be cryptic and require significant analysis and research time to understand their meaning. Good lab reports provide context for the results data, likely in the form of ranges. They also use formal names of mutations rather than common names or different nomenclatures, which can leave room for misinterpretation. Most important, genomic results should help guide an oncologist’s treatment choices for a patient. A good report gives the oncologist suggestions for treatment options including clinical trials.

5. Develop a good relationship with your laboratory service providers.

Just as your representatives from drug manufacturers can help keep you up-to-date on the latest drugs, your lab representative should keep you informed of what tests are available, answer questions about specific applications, and help make sure you are ordering the test that will give you the information you need.

Oncologists have always depended on their lab partners to help them provide high-quality care to their patients. Today, with increased use of molecular testing, the need for trusted relationships is greater than ever before. Collaboration between oncologists and labs will be a cornerstone for the delivery of more personalized treatment and proactive prevention.

Catherine Tsien Swick is senior director for Lab and Precision Medicine at McKesson Specialty Health, and Lori C. Brisbin is chief commercial officer for med fusion.