Your Companion Diagnostic Partner
The biopharmaceutical industry has seen a shift towards the necessity of using biomarkers to develop more effective therapies. In an extremely competitive personalized medicine market, your choice of diagnostic partner is more important than ever.
According to the Personalized Medicine Coalition, more than 25% of new molecular entities (NMEs) approved by the FDA in 2015 and 2016 are personalized medicines. Empire Genomics has both the technical expertise and experience needed to take your biomarker from the discovery phase completely through the complex regulatory path to an FDA approved companion diagnostic. We have the flexibility needed to tailor services to fit your project, and will work with your team to understand priorities and identify the critical path of your project.
The Empire Process
The Empire Process is based on a consultative approach to understand your project needs and to create a robust companion diagnostic program that is appropriate. We continually communicate developments with you to make sure the project is successful.
Project Scope – Understand the project requirements and identify the critical path of the project. Define project timelines with full cost analysis.
Assay Development - Work with your team to develop the right mix of testing for your project.
Knowledge Transfer - Understand all implemented methods that affect workflow. On-site training available if required.
Data Analysis, Storage, and Reporting - All data collected will be stored and analyzed by our expert staff. Data will be provided to the client in the desired format using our secure online information portal.
CASE STUDY - NFKB2 and Multiple Myeloma
Empire Genomics has developed a first in class proprietary NFKB2 fluorescent in situ hybridization (FISH) assay for use in companion diagnostic trials to determine proteasome inhibitor response with the rearranged NFKB2 gene.
Empire Genomics is currently partnering with Emory University and Millennium Pharmaceuticals to provide clinical services and targeted NFKB2 assays for a companion diagnostic Phase II clinical trial in patients with multiple myeloma (NCT02765854).
Initial research has shown:
- Loss of 3’ end of gene transcript is associated with poor treatment response in multiple myeloma
- Custom break apart probe confirms chromosomal rearrangement
- Assay has also demonstrated the potential for predicting therapeutic response in lymphoma, leukemia and solid tumors