Companion Diagnostics Partner
Geneuity brings expertise and experience to support companion diagnostic development and validation for regulatory approval.
Geneuity’s role in Companion Diagnostics (CDx) involves:
- Contract assay development for drug discovery
- Clinical validation for companion diagnostic manufacturer
- Development of lab developed tests
- CLIA laboratory services to support commercialization of CDx
Companion Diagnostic development often demands a three way partnership. Between drug development, companion diagnostic manufacturer, and the clinical testing laboratory. What is common between all three is clinical utility, regulatory approval, time to market, and costs.
Clinical utility must be proven in a prospective, hypothesis-driven clinical trial that includes both drug and diagnostic, typically a pivotal / Phase III trial. Early stratification changing ways to enroll patients now include biomarker assessment for trial recruitment to Phase II and Phase III drug trials.
The regulatory approval pathway considers premarket approval versus laboratory developed test, whether to sell a diagnostic kit or to sell a laboratory service. Further analyte specific reagents are exempt from pre-market notification enabling early adoption of technology. A global perspective and strategy is necessary to account for both FDA, EMA, and other countries regulatory approval process and timeline. The FDA and EU have been working to harmonize drug approval timelines and processes, however approval of medical devices is often sought first through EU clinical trials and CE mark obtained prior to US FDA submission due to process timelines. Advice from the FDA can be sought proactively during pre-investigational device exemption (IDE) session, or using the Voluntary Exploratory Data Submission (VXDS) process that involves providing exploratory genomic data.
Potentially high response by a rarer population
EXAMPLE: 5% NSCLC have an ALK gene rearrangement and using an Example: ALK inhibitor Crizotinib, the tumors shrank or stabilized in 90% of cases
Subsequent clinical data finds a link to a biomarker associated with treatment response
Example: KRAS mutation status and Erbitux and Vectibix
Subsequent clinical data impacts broader utility of the drug through additional application of the diagnostic
Example: Her2 over expression and treatment with Herceptin in breast also found effective in other trials for metastatic gastroesophageal gastric cancer