Multiply your drug sales with a high accuracy CDx.
Companion diagnostics (CDx) can be used to predict patients who would benefit from a specific treatment. Therefore, CDx is becoming more and more popular in the drug development and approval process as well as in post-approval marketing.
Moving a drug from the second or third line to the first will guarantee the drug's success. In addition, a companion drug that is capable of identifying strong responders of a specific therapy enables higher pricing and therefore is able to create at least as much revenue as a full market distribution.
Our biomarker signatures will help to achieve this important step forward by
Based on our unique EVO algorithm, which combines concepts from artificial intelligence and machine learning, biomarker signatures enable a new era of reliability in responder selection and an increased speed to market, ultimately resulting in higher prices.
Our advanced technology allows us to support you in achieving your goals. Depending on your individual requirements we can
Out of the broad range of benefits, table A contrasts typical performance parameters resulting from OakLabs' technology compared to the conventional statistical methods. The parameters refer to the colored data points of the ROC curves in figure 2.
|Patient selection||Traditional Biomarker||OakLabs's Biomarker Signature|
|Sensitivity of responder selection||90%||95%|
|Specificity of responder selection||60%||94%|
We have a proven track record and can look back at numerous successful CDx projects. Learn more about the reasons why pharma companies worldwide trust in OakLabs:
There is a broad range of data you can acquire from patients including including proteins, mRNA, miRNA, proteins, DNA methylation, metabolites or SNPs in various sample types like plasma, serum, urine, liquore, biopsies or facies. Which sample type and biomarker type is most suitable strongly depends on the individual clinical trial. The table below gives a brief overview of regular settings we support/accompany. Nonetheless, we profoundly evaluate each project individually and therefore ensure to proceed with the best strategy.
|Technology for signature development||Antibody Microarray Platform||DNA Microarray Platform||LCMS and GCMS|
|No. of detected analytes||> 900 proteins||> 30,000 mRNAs||> 1,000|
|Analytes||Broad set of different protein classes as well as relevant pathways in biomedical studies||Genome-wide gene expression analysis||~30% known and ~70% unknown metabolites (polor and lipid metabolites)|
|Compatible sample types (starting material)||Plasma, Serum, Urine, Liquor||PBMCs, Tissue samples||Plasma, Serum, Urine, Liquor, Facies|
|CDx translation technology||ELISA||RT-qPCR or micrarray-based||LCMS / GCMS / Other (depends on particular metabolites in biomarker signature)|
Rapid translation to CDx
broad equipment compatibility to run CDx in labs
|Rapid and cost-efficient translation to CDx
flexible technology depending on marker set size (RT-qPCR or microarray)
|Diverse technology options for translation to CDx|
The average development time for a CE IVD CDx is 9 - 12 months including the required software compliant to the FDA & IEC 62304 regulation for medical devices. Major factors influencing the time needed are whether we start with existing data or acquire data ourselves and if a technology transfer from biomarker signature discovery to CE IVD CDx is required.
OakLabs' innovative 9-year developed EVO algorithm manages all serious conflicts associated with biomarker signatures including overfitting, missing values and false classification. EVO's algorithms are based on artificial intelligence (AI) and machine learning and provide superior results.
OakLabs utilizes graphic cards (GPUs) to handle EVO's extreme computing demand.
EVO's biomarker signature is transferred to OakLabs' LDT development and FDA & IEC 62304 compliant software development.
With the help of CDx you can increase the number of responders and prove a substantial benefit for this subgroup of patients. Thus, you can initiate a change of the treatment guidelines and turn your second or third line drug into a first liner.
Yes, that's totally possible. We can either work with existing data or acquire data in our own lab.
This question cannot be answered easily and depends on the individual project. For example, it makes a difference if the data can already be provided from your side or if no data is available yet. We are usually working with performance-based pricing components which will also differ in every development project. Please contact us to receive a first price estimation.
Please write us a short email to firstname.lastname@example.org expressing your interest and - if possible - also provide us with some initial information about your drug portfolio. One of our CDx experts will get in touch with you and discuss your needs and expectations in detail.
A biomarker refers to a measurable indicator of some biological state or condition.
One application of biomarkers is the prediction of a response to a therapeutic intervention.
CDx stands for Companion Diagnostics which basically means a test to predict patients who would benefit from a specific treatment.
It can be used as a companion to a therapeutic drug.
Companion diagnostics are co-developed with drugs to help selecting or excluding patient groups.
The prediction of the response is based on biomarkers.
While a single biomarker can only explain a small portion of the responses, a biomarker signature is capable to access the major proportion of the complex biological process. The use of a rapid and treatment-specific biomarker signature enables a new era of reliability in responder selection.
For most drugs it is recommendable to check for the presence of a responder signature either in the clinical trials phase or for market access strategies. However, it makes particular sense for drugs in competitive markets which do not have a standalone first-line status and are in need for strong sales arguments. In addition, identification of responders can be favorable for drugs with a long efficacy, because they enable a more suited treatment for the non-responders and prevent them from suffering and side effects.