The Future of Molecular Diagnostic Testing Will Depend on TREs

Molecular diagnostic companies are facing significant challenges to staying relevant, competitive, and profitable:

✔ Discovering and validating better biomarkers for precision medicine 
✔ Getting support for reimbursement in a crowded marketplace
✔ Growing demand from healthcare providers to get more actionable insights from patient data 
✔ Commercializing assays as regulatory guidelines shift

If your company has years’ worth of rich patient assay data and/or has a line of sight to generating large amounts of assay data, it is in a unique position to leverage that growing trove of omics real-world data (oRWD) in unique and innovative ways to address these challenges.

Companies that invest in a solid data strategy will win market share and become the market leader in this new era by using their data in at least these 3 ways:

1. Responsibly participate in the exploding oRWD market; Whether licensing direct access to de-identified data for biopharma research or creating applications to deliver insights, the most successful companies will have a data infrastructure that will: 
   
   ✔ Keep control of patient’s data and religiously protect privacy
   ✔ Quickly evolve and pivot as compliance and privacy norms and regulations shift
   ✔ Be flexible enough to incorporate new omics modalities and indications as their test portfolios expand
   
   
2. Access and link clinical outcomes data through win-win partnerships with a variety of sources; Organizations with access to outcomes data will have the advantage in developing better evidence-based products for patient care,  demonstrating real-world impact of new products for reimbursement, and maintaining compliance with new regulatory requirements. Companies that  responsibly incentivize data sharing from partner health systems with rich, real-world clinical outcomes data for patients receiving their tests will be at a particular advantage.
   
   
3. Outcompete by providing a way for health systems and healthcare providers to get more from their own patients’ data;  Today, it is table stakes to deliver patient data along with the singular test results. Preferred vendors must be able to not only deliver patient data, but also make it easy for healthcare providers to mine the data for meaningful insights for improved patient care. For example, BI dashboards to help ensure tests are being ordered appropriately, or apps for “patients like mine” analyses for clinical care pathways.

The common thread among all three of these approaches is a robust data infrastructure to gather and link sensitive data, as well as support best business practices for data sharing. That foundational component is a trusted research environment (TRE).

That’s the upshot of a new white paper we released to help scientists and leaders at diagnostic companies understand how a TRE can help them achieve their business goals, create new revenue streams, and meet changing expectations. A TRE provides sophisticated data management and analysis capabilities with the security and regulatory compliance required for protected or sensitive classes of data. In the white paper we explain how this critical infrastructure piece is leveraged to support all three objectives, as well as the key considerations to create, update, or future proof the TRE component of their enterprise data stack. 

Access the full white paper, Big Data Is Driving the Future of Molecular Diagnostic Testing, to learn more about TREs, evolving expectations in the diagnostics field, and key considerations in choosing the right TRE.