Rapid Feasibility Test for a Drug in Clinical Trial or a Diagnostic Test in Development
While the informative value of a single biomarker is often limited, biomarker signatures are capable of achieving improved accuracies.
OakLabs’ algorithms from artificial intelligence and machine learning enable a new era of molecular diagnostic tests - due to the superior accuracies we achieve.
Each project is carefully evaluated based on our wide-ranging experience. If required, our lab will acquire genome-wide gene expression data of a number of representative samples. After a comprehensive data evaluation - either of the data we acquired or of your molecular data, a preliminary robust biomarker signature will be developed.
Since we are absolutely confident in our approach and our ability to make decisions regarding the success of biomarker signatures due to years of experience, we are willing to have the risk on our side: If the pre-agreed milestone is not achieved you will not need to pay.
OakLabs aims at developing a preliminary biomarker signature based on the data aquired in previous steps. For validation of the preliminary biomarker signature, OakLabs will predict the response status of data obtained from patient samples with blinded classification using the preliminary biomarker signature. The classification of the patients will be provided in a password-protected file. Next, OakLabs will provide the classification of the patients from the validation cohort and will in exchange receive the password for the classification file. Both parties and now are able to determine the accuracy of the developed preliminary biomarker signature.
Our service in the field of biomarker signature development is flexible as well as adaptable and includes steps from data acquisition, development and validation of robust biomarker signatures, sample size estimation as well as the IEC development of software for medical devices. We work in close collaboration with several partners who cover the technology transfer to a CE-IVD assay IVDR compliant and in harmonization with laboratory diagnostics’ equipment as well as execution of performance evaluation studies.
Read more about the use of our biomarker signatures in clinical trials or for the development of standalone companion diagnostics (CDx) for approved drugs.
Interested in working together with us on a biomarker signature to boost the success of your product? Please fill out the form below. We will get back to you within three business days.
What we will be looking into:
The project scope of our risk-free signature development is as follows:
- Acquisition of genome-wide gene expression data of 24 responders and 24 non-responders on ArrayXS Human / ArrayXS Human FFPE
- Comprehensive evaluation of the data and development of a preliminary robust biomarker signature
- Assessment of feasiblity for a high accuracy CDx
- Indication of required patients for CDx
- Evaluation of confounding factors
The criteria depend on your specific project, they need to be negotiated and will be based on our experience.
In that case, there will be no payment required from your side. To complete the project, we will deliver a short final report. However, the complete data set will not be handed over in this case.
If requested, the comprehensively analysed and visualized data can be delivered at a fee.
First of all, you will receive a report demonstrating the success. In addition, you will receive the comprehensively analysed and visualized data. What we will not deliver at this point, is the biomarker signature.
The average time from patient samples to the preliminary robust signature is 12 weeks.
The price for milestone 1 will be about 50,000 EUR if we acquire data in our lab. You will only need to pay if this milestone is reached.
The price for all following steps will be milestone based again as well as success related. Pricing components can include royalites.
Yes, we can handle all types of gene expression analysis data, including RNA-Seq, Affymetrix, Illumina and Agilent.
The sample could be almost any type including whole blood, particular blood cells, tissue, urine and others. We are ready to help you determine which sample type is most promising for your project.
Though our lab can handle single cell samples, according to our experience single cells are not well suited to develop a CDx.Contact us to do so.
Partially, our algorithms can handle proteome data but we do not acquire protein data in our own lab. However, a protein as well as an RNA signature have a number of advantages. It might be good to take a step back and discuss both options. Contact us to do so.
Please write 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 refers to a test which predicts patients who would benefit from a specific treatment.
It can be used as a companion to a therapeutic drug.
Companion diagnostics are either co-developed with drugs or after their market release to help select or exclude patient groups.
The resulting 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 of accessing 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 many drugs, it is suggested to check for a responder signature either in the clinical trials phase or for market access strategies. However, it makes particular sense for drugs in competitive markets. Analyzing a patient's sample prior to the treatment may help doctors to prescribe the most effective drug. Here, CDx offers strong sales arguments and enables competitive advantages. Additionally, identifying responders can be favorable for drugs with delayed response times as this will enable the early initiation of a more suitable treatment for non-responders and prevent them from suffering and side effects.