What are Diagnostics 2.0?

Pharmaceutical Executive: How have recent developments in genomic research transformed cancer care?
Marc Stapley: There’s been a lot of change in diagnostics in general, but particularly in oncology over the last five years. It’s clear that next gen sequencing has created a new paradigm that has enabled us to come up with new tests and put them in clinical use. The way that the industry has transformed has gone from a model driven by volume (even if the test was painful) to a more responsible model that generates evidence in a way that ensure durable ongoing reimbursement for a test, having it released to the marketplace, and having it adopted by physicians.

PE: What is diagnostics 2.0?
Stapley: Diagnostics 2.0 is responsible launching of molecular diagnostic tests that focuses on strong, robust scientific evidence that demonstrates not just the clinical validity of a test, but that it has use for physicians. It changes the way that physicians practice. We’re very focused on physicians as our allies and the people we’re enabling to do their job the way they need to do it.

Diagnostics 2.0 is a focus on developing evidence very early on.

PE: What are the core tenets of diagnostics 2.0?
Stapley: The core are robust science supported by machine learning and AI technology. It is robustly completely clinical studies and ensuring that those studies are focused on the patient population for which the test is intended. It’s also about making sure that the data demonstrates clear patient and physician benefit in the treatment path and an ongoing commitment to generate evidence during the life of the test.

PE: What diagnostic areas are investors focusing on?
Stapley: There’s a few areas that investors have been focused on for several years. Some of them have come and gone. Early detection was getting a lot of focus, and it hasn’t gone away. It’s still getting a lot of attention from investors and companies. Today, however, in oncology, areas like prognostic and predictive diagnostic clinical tests that fit into the physician workflow and provide additional insights are clearly getting attention.

Another area is minimum residual disease (MRD), which is getting a lot of traction for a number of reasons. It’s very helpful for patients who have been treated, whether by therapy or surgery, and you’re looking for residual disease state or recurrence. This test can be used at multiple time points after the treatment. It’s an interesting new area and getting a lot of attention.

One thing we’re seeing is that the existence of MRD could be a potential endpoint in clinical studies because it’s proving to be a good indicator.