The industry’s first exosome-based diagnostics are designed to overcome the limitations of currently available molecular diagnostics and deliver on the true promise of personalized healthcare. We are leaders in collaborating with the biopharmaceutical industry, helping companies leverage exosome-based science to enhance the R&D process, from biomarker discovery through validation, and the development of sophisticated companion diagnostics to maximize the potential of targeted therapies.
Biomarker strategies are incorporated into virtually every R&D process, starting with the earliest stages of clinical development. Sourcing tissue to identify biomarkers can lead to delays in clinical trial recruitment and complicate clinical study design and implementation. By providing biopharma companies with biofluid-based solutions for clinical trials, we can overcome these tissue-related obstacles.
Utilizing our best-in-class technology, we can assess biomarker status without using historical tissue or requiring a biopsy. This offers biopharma companies several key advantages including:
- Access to a virtually unlimited supply of molecular information via biofluids
- Enhanced freedom with clinical trial design
- Accelerated clinical trial enrollment
- Shortened study duration
- Reduced overall clinical study costs
- Potential increased time on patent life
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ExoDx Lung(T790M) is now available for Research Use Only (RUO) and will soon be available for clinical use. The test isolates and analyzes both exoRNA and cell-free DNA (cfDNA) from plasma.
ExoDx Lung(T790M) is a blood plasma test that provides sensitive detection of the T790M resistance mutation that arises in 50 to 60 percent of NSCLC patients being treated with EGFR inhibitor therapies. The test can enable assessment by serial blood draw, monitoring patients for development of resistance while on EGFR inhibitor therapy. Currently, the standard method for assessing the T790M resistance mutation is a tissue biopsy, which is sub-optimal in an advance-stage patient population. Patients are rarely positive for EGFR T790M at diagnosis. Assesing for resistance is only done at time of progression on an EGFR inhibitor.