“Fit for Purpose” Solutions for Biomarker Discovery and Validation
ResearchDx offers biomarker discovery, characterization and validation services based on a broad selection of DNA, RNA, protein and metabolite approaches. With extensive experience in “Fit for Purpose” validations, our team will develop, validate and perform assays to regulated standards (GXP, CLIA, FDA) including providing assistance with the pertinent regulatory filings. For commercialization of your diagnostic biomarker, there are multiple pathways that include:
- Biomarker discovery and validation based on your need
- Development of assays customized to your application and exclusively performed in our regulated CLIA laboratory
- Development of custom diagnostic reagents that are kitted, manufactured, built on-site and shipped to your global locations to enable third-party use
- Development and validation of your Laboratory-Developed Test (LDT) with testing performed on-site at ResearchDx
- Development of in-vitro (Italicize) diagnostic devices (IVD) through regulatory approval for full commercialization, globally
Schedule a consultation with our research team to discuss your specific needs.
Companion Diagnostics and Diagnostic Biomarkers in Personalized Medicine
Because every person is a genetically distinct individual, the adage “one treatment for one disease” is no longer applicable in the new age of molecular and personalized medicine. Today, the ability to stratify patients who may or may not benefit from a therapy is the key component to diagnosing and managing clinical disease and outcomes. Drug selection and dosage can now be modified according to individual biological characteristics, ethnicity, gender and traditional diagnostic testing.
For biopharmaceutical companies developing targeted therapies, companion diagnostics are required to ensure the safety and efficacy of the development process and their subsequent clinical use applications. Use of diagnostic biomarker and molecular diagnostics provide a conduit to stratify patient populations who would benefit from certain therapies and ensures the selection of the appropriated targeted therapeutics based on the patient’s specific profile. This vital information enables healthcare providers to focus on the most effective therapeutic options and alter regimens for their patient, when necessary, in a very timely manner. Diagnostic biomarkers also provide the advantage for customizing drug dosage based on metabolism biomarker status as well as the ability to monitor treatment success and failure.
What are biological biomarkers?
- Measureable biological DNA, RNA, protein or metabolite components
- Qualitatively or quantitatively analyzed in specific types of samples
- Described by features that may specify a specific condition, disease or a response to therapeutic treatment
- Risk biomarker, identify those who are “at-risk” to develop a disease
- Prognostic biomarker, predict disease progression or recurrence, or identify persons likely to or not to respond to a targeted therapeutic intervention
- Diagnostic biomarker, used to detect a disease in early stages, classify disease sub-types or characterize a person’s response to treatment