The “One Number” Promise: Insights from the Next Generation Dx Summit Highlight the Need for Integrated, Unified and Actionable Data

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Twenty years ago, the foundation for Next-Gen Sequencing was set. Ten years ago, advances made NGS a viable platform. Today, clinicians are just starting to use the platform for clinical benefit. It takes a long time to bring a new platform to market. NGS is just one of many that are emerging to advance clinical practice.

Recently, the industry had a chance to witness promising new technologies at the Next Generation Dx Summit. As always happens, the debate around the nuances of these technologies spilled out into the hallways long after the presentations were over. Instead of the promises of speed or accuracy, another important message emerged from the purveyors of these platforms: integration. Integration represents the opportunity to address two significant challenges: sample scarcity and disjointed, unactionable information.

Clinical trial programs are running at their limits of usable subject samples (blood, tissue, etc). Programs must get more insight out of fewer samples. However, the proliferation of biomarker platforms has put demand on samples and exacerbated the information available for decision makers.

Additionally, from liquid biopsy to CTCs to tissue-based biomarkers, fragmented pieces of biomarker insight are being created that lead to a loose collection of endpoints that look like a kaleidoscope twisting aimlessly.

These problems of sample scarcity and incoherent insights have created an overwhelming concern within pharma partners: how to bring everything together into one, cohesive picture that can drive better success for clinical programs.

At a recent dinner with a top pharma exec, after all the salient points were made about why a certain platform should be used for a key endpoint, the exec finally weighed in. “I just want to get one number that I can trust.” A significant integration problem exists.

Actionable insight comes from the “one number” that is distilled from the vast amounts of data collected across platforms. Each program has that one key measure that is the true indicator of success (or failure).

For example, proper integration puts ALK mutations in pathological context with tumor boundary responses, painting a better picture for development of treatment strategies or confirmation of desired mechanism. Quantifying these two elements and creating a composite score can deliver on the “one number” promise. In most cases, the components of the “one number” approach must contain systemic, whole tumor, and pathology context measurements which are complementary nature. While development teams must push for better tools for diagnostics, the importance of integration and context must never be overlooked. Getting the whole picture means mastering integration – from new technologies in tissue such as NGS to CTCs to cfDNA to Flagship’s cTA™ technology and beyond. The promise of any new platform is governed by its ability to combine its own specific value with complement technology approaches which create a holistic “one number” patient prediction.

“Plays well with others” is an important factor on any technology’s resume.

Brett Malone
VP, Business Development
Flagship Biosciences