PHARMA SERVICES
Biomarker & Companion Diagnostic Discoverywith Genomic Intelligence®
A COST-EFFECTIVE, HIGH-VALUE INSURANCE POLICY FOR EXPENSIVE CLINICAL TRIALS
Lack of efficacy or adverse effects are the leading cause of clinical trial failure. Mining data from such trials can identify predictive genomic biomarkers that stratify the subset of patients for whom the drug is effective and safe, giving new life to the molecule.
But if you haven’t laid a foundation for such analyses at the start of the trial, it will be too late to collect the necessary samples and data once efficacy or safety issues are experienced. Partner with Variantyx before your clinical trial starts to insure against unnecessary loss of valuable data and time.
OUR FOUR STEP PROCESS
Biobank samples
DNA samples are biobanked at minimal cost at the time of Phase II enrollment to ensure retrospective access in case of a triggering event.
Sequence and stratify
If needed, a subset of biobanked samples are retrospectively sequenced and analyzed for genomic biomarkers that distinguish positive responders from non-responders or identify patients likely to experience an adverse effect.
Test and re-submit
Regulatory approval is obtained to test the identified biomarker and sequence the remaining biobanked samples in order to prove its utility as a pre-treatment predictor of benefit.
Gain approval
The biomarker is used for Phase III trial and post-approval.
Biobank samples
DNA samples are biobanked at minimal cost at the time of Phase II enrollment to ensure retrospective access in case of a triggering event.
Sequence and stratify
If needed, a subset of biobanked samples are retrospectively sequenced and analyzed for genomic biomarkers that distinguish positive responders from non-responders or identify patients likely to experience an adverse effect.
Biobank samples
DNA samples are biobanked at minimal cost at the time of Phase II enrollment to ensure retrospective access in case of a triggering event.
Sequence and stratify
If needed, a subset of biobanked samples are retrospectively sequenced and analyzed for genomic biomarkers that distinguish positive responders from non-responders or identify patients likely to experience an adverse effect.
Test and re-submit
Regulatory approval is obtained to test the identified biomarker and sequence the remaining biobanked samples in order to prove its utility as a pre-treatment predictor of benefit.
Gain approval
The biomarker is used for Phase III trial and post-approval.
Biobank samples
DNA samples are biobanked at minimal cost at the time of Phase II enrollment to ensure retrospective access in case of a triggering event.
Sequence and stratify
If needed, a subset of biobanked samples are retrospectively sequenced and analyzed for genomic biomarkers that distinguish positive responders from non-responders or identify patients likely to experience an adverse effect.
Test and re-submit
Regulatory approval is obtained to test the identified biomarker and sequence the remaining biobanked samples in order to prove its utility as a pre-treatment predictor of benefit.
Gain approval
The biomarker is used for Phase III trial and post-approval.
UNPARALLELED BIOMARKER ANALYSIS CAPABILITIES
Proprietary method and technology powered by unique data
Our WGS-based testing methodology utilizes proprietary algorithms to detect all major types of genetic variation, identifying a comprehensive set of potential biomarkers. We are able to stratify trial participants according to unique data points available only within our data collection, including:
- Curated clinically relevant tandem repeat expansions
- Curated previously “unmapped” structural variants 2+ billion variants and their population frequencies (including frequencies of CNVs and repeat expansions)
- Knowledgebase of tens of thousands of previously analyzed variants
- Medical records of thousands of patients
This combination of method, technology and data enables better biomarker discovery and companion diagnostic development that may save the molecule and provide a new path to FDA approval.
AN ONCOLOGY BIOPHARMA PARTNER CASE STUDY
We are currently working with a well-known oncology biopharma partner to stratify patients due to differential adverse effects experienced during a recent phase II trial. A subset of the 500 biobanked patient samples were divided into two cohorts of 25 – one cohort having experienced adverse effects and the other not. Following whole genome sequencing, the cohorts were analyzed for potential genetic biomarkers. Promising initial findings are currently being investigated through sequencing and analysis of additional biobanked samples.