Veracyte CEO Marc Stapley outlines how single-cancer testing is giving pathologists, clinicians, and patients an edge with more options in diagnosing and treating a variety of diseases.

By Chris Wolski

Over the past several years the goal of many testing strategies has been in developing silver-bullet multi-cancer screening techniques that can potentially identify dozens of diseases at one time. South San Francisco-headquartered Veracyte is betting on a different approach: single-cancer testing focusing on specific disease types.

The company believes this single-cancer testing approach gives clinicians and their patients better insights into the disease and more options for treatment as opposed to multi-cancer or multi-disease techniques.

CLP recently spoke with Veracyte CEO Marc Stapley about the company’s diagnostic technology, the benefits of its single-cancer testing strategy, and its next steps in the U.S. market and beyond.

Stapley’s answers have been edited for length and clarity.

CLP: You specialize in single-cancer testing. Why? Are there any specific advantages you’re delivering to patients, providers, and labs?

Marc Stapley: By focusing on tests that answer specific questions in a given disease area, we believe we are ideally positioned to deeply understand clinicians’ needs and specific pain points as they work to guide patient care. This approach has enabled us to demonstrate clinical utility for our tests, which has been key to securing reimbursement for them, and adoption.

In general, I think it’s more difficult to demonstrate performance and clinical utility across multiple cancers with a single test (i.e., multi-cancer early detection, or MCED, tests). This can be especially true for screening tests, where the costs will quickly add up when you consider the additional testing and procedures that will likely be needed to find a single cancer.  

CLP: You are looking at genomic causes of cancer, right? Can you describe the technology/methodology you’re using?

Stapley: Veracyte’s approach combines whole-transcriptome data and machine learning to answer specific clinical questions, such as whether a thyroid nodule that is deemed indeterminate by cytopathology is benign or suspicious for cancer (with our Afirma test) or if a patient’s prostate cancer is likely to metastasize (with our Decipher Prostate test). Thanks to this whole-transcriptome approach we can extract significant data on the samples we test in our CLIA labs, which we believe can help further advance understanding of the genomic underpinnings of cancer in a research setting. Ultimately, we believe this will help lead to more personalized approaches to cancer care.

CLP: While every Veracyte test is set for a single cancer—the purpose of each test is diagnostically different. For example, your prostate test is prognostic, while your thyroid test is aimed at avoiding overtreatment. Why not just a black-and-white, positive-or-negative approach?

Stapley: We focus on addressing specific unmet clinical needs, which often vary by indication. In thyroid cancer, for example, many patients have historically undergone unnecessary diagnostic surgery because cytopathology results on their fine needle aspirations were indeterminate. So, our Afirma test helps identify those patients whose nodules are benign so they can avoid surgery. In prostate cancer, diagnosis is not the key challenge; rather, physicians want to know which patients will likely have aggressive disease so they can determine whether and when to intensify treatment. One of Veracyte’s biggest priorities is working collaboratively with clinicians to better understand their unique needs. Through this collaboration we gain insights into where clinicians need better data to help them and their patients to make more informed decisions about what to do next.

CLP: You process your own tests in the U.S., but outside the U.S. you’re planning on selling the testing kits to labs directly. What type of workflow advantages are you offering labs?

Stapley: Veracyte’s exclusive diagnostics rights to the nCounter Analysis System allows us to perform our tests globally as in vitro diagnostics (IVDs). This ability is a key driver for our expansion outside of the U.S., where it is not logistically feasible to send samples back to our labs in California and where some countries’ regulations do not allow patient samples or clinical data to be sent internationally. Our decentralized approach outside of the U.S. enables labs to run our advanced genomic tests locally, closer to the patient. The nCounter is fully automated and easy to use, facilitating simultaneous multiplex testing of up to 800 RNA, DNA, and protein targets with minimal hands-on time.

CLP: Do you expect to offer the testing kits to U.S. labs in the future?

Stapley: We believe our current centralized approach of performing our tests in our CLIA labs works well in the U.S., and have no current plans to change this. But the IVD strategy that we are deploying in Europe gives us the optionality to adopt a distributed approach in the U.S. if we ever need to. As a matter of fact, we do offer one of our tests to other labs in the U.S., our Prosigna Breast Cancer Assay, which was developed originally as an IVD for the U.S. market. This is a prognostic test that helps measure breast cancer recurrence risk and inform treatment decisions.

CLP: Are your tests reimbursed?

Stapley: All our commercially available tests are reimbursed by Medicare. Additionally, our Afirma test for thyroid nodule diagnosis and Decipher test for prostate cancer risk stratification are reimbursed by the leading private payers in the U.S., covering more than 275 million and 195 million lives, respectively. Much of this success is due to the extensive body of clinical evidence we have developed for our tests. Our Decipher Prostate test, for example, has over 70 published papers demonstrating its performance and utility, and is the only test being studied prospectively in multiple National Cancer Institute-sponsored, randomized Phase 3 trials.

CLP: Can you talk about the next test on your diagnostic agenda? How will it work, and in what way will it be focused, e.g., prognostic, indicative, etc.?

Stapley: We have several new tests in our pipeline. We are particularly excited about our Percepta Nasal Swab test, which is designed to help physicians determine which patients with lung nodules found on CT scans are high risk for cancer and warrant further procedures and which are low risk and can likely be monitored. We believe our test will be a game-changer in how lung nodules are assessed, including among the 15 million high-risk patients in the U.S. who are eligible for annual CT screening. Additionally, we are developing our tests as IVDs and plan to submit three tests for CE marking in the EU (including our tests for prostate and lung cancer) over the next three years, creating an extensive menu to achieve our vision of transforming cancer care for patients all over the world.

Chris Wolski is chief editor of CLP.