Addressing challenges for oncology diagnostics and therapeutics
Advances in diagnostics and increased understanding of cancer biology now allow clinical predictions based upon the molecular characterization of a tumor. Yet many stakeholders question the utility of those predictions and whether existing frameworks are sufficient to enable a meaningful and economically stable step forward in patient outcomes.
To help prepare US healthcare leaders for what many acknowledge is a paradigm shift in the diagnosis and treatment of cancer, Tapestry Networks launched the Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) Working Group in 2013.
SPOT/Dx yielded two outcomes. One focused on closing the regulatory divide between laboratory-developed tests and FDA-approved companion diagnostics and led to the design of the ongoing Diagnostic Quality Assurance Pilot, which is implemented today by the College of American Pathologists. The pilot is governed by a scientific and technical working group that comprises leading experts in next-generation sequencing and molecular diagnostics and a multistakeholder advisory committee of payers, leading provider representatives, Friends of Cancer Research, industry, and others.
The other outcome was a focused summit on better integrating genomics into the clinic. This lives on today as Tapestry’s Diagnostics Innovation Network, which now also focuses on responsibly bringing genomics into the hands of the consumer.
From 2013-2015, SPOT/Dx served as a multi-stakeholder forum for bringing together key thought leaders and decision makers across the public and private sectors, including clinical and policy experts, regulators, third-party payers, patient advocates, and industry leaders. SPOT/Dx was supported by Abbott Molecular, Amgen, Clarient Diagnostic Services, GE Healthcare, GlaxoSmithKline, Illumina, and Janssen/Johnson & Johnson.
SPOT/Dx tackled several topics in precision medicine and diagnostics for cancer, ranging from reimbursement policy for laboratory tests to proficiency testing to expanding the real-world evidence base for precision medicine in oncology. Learn more about SPOT/Dx discussions here and here.