Participants agreed generally on the consensus that companion diagnostics are already influencing biopharma practices e.g., coordination with partners, timing of projects, bridging studies from clinical trials to market. and will inform the upcoming generations.
Also, the fact that multipanel assays are now more likely to emerge than the current paradigm of “single analyte diagnostic for one specific therapeutic indication.”
BioInformatics will need to be made more accessible to all users, especially as panelbased assays become more prevalent. Conveying complex data to physicians, payers, and other stakeholders will require transparent analytical capabilities, explanatory graphic displays, clear treatment options, and user friendly interfaces.
Strategies for identifying companion diagnostics are becoming more refined and precise and will require biology based criteria for biomarker selection. Both Nicholas Dracopoli and Kenneth Emancipator stressed that a deep understanding of the underlying biology is critical to finding and confirming a companion diagnostic in oncology. Several speakers chimed in with the point that good science and medicine need to go hand-in-hand to develop an effective device and a safe and efficacious drug.
Applications of precision diagnostics has grown to include areas beyond oncology. In general, cancer testing was the first field to apply next generation sequencing (NGS) in diagnostics. NGS is becoming routine in other fields as well. Oscar Puig addressed the use of cascade NGS to expand the offerings for early and accurate diagnosis of genetic causes for sudden arrhythmic death syndromes (SADS). He discussed how cascade screening (identifying relatives at risk for a genetic condition after molecular diagnosis in an index case) could result in more affordable diagnostics for patients in rare, hard to predict conditions. Puig also noted that precision medicine could also expand to include preventive precision medicine (e.g., implantable cardiac defibrillators before an episode for those at risk for SADS). As a consequence of expanded applications, the cost for NGS would be driven lower to the benefit of all therapeutic areas.
Tom Fare and Oscar PuigDirector of Strategic Alliances | Chief Science Officer
If you’re interested in Companion Diagnostics (if your involved in Precision/Personalized Medicine or Biomarkers you likely should be) the notes may be of interest to you.
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