One size does not fit all.
Need to cover a specific gene or exon?
We can make a custom assay to your precise requirements.
RUO & IVD Kits
We can develop custom liquid-biopsy panels for patient enrollment in your clinical trials as an IDE. After initial enrollment, the assay is an excellent development tool, allowing for real-time monitoring of therapy effectiveness and response due to dosage adjustments. During phase II/III, we can work with you to bring to market a non-invasive companion diagnostic (CDx).
Your assay will be developed under rigorous design control.
Validation usually includes designing the target capture probes and analyzing healthy donor plasma and cell-line admixtures to ensure coverage and sensitivity. Because every request is unique, we work with you to ensure that we meet your research or clinical goals.
The ctDx platform was designed from day one to be a distributed IVD kit. In order to help the most patients, a medical technology should be as close to the patient as possible. Shipping samples to a central lab is a waste of precious time and allows for samples to be lost or damaged during transit.
To discuss your specific requirements, please contact us via the inquiry form.