Companion Diagnostics and Diagnostic Biomarkers in Personalized Medicine
Every person is genetically distinct at a molecular level, therefore,” one disease, one medicine” is not applicable in personalized medicine. Today, patient stratification is the key component in diagnosing and guiding appropriate therapy. Drug selection and dosage are modified according to individual biological characteristics, ethnicity, gender and traditional diagnostic testing. Companion diagnostics extend this concept to include diagnostic biomarker assays and genetic testing to stratify patients who may or may not respond to a particular therapeutic. This vital information enables healthcare providers to focus on more effective therapeutic options for their patient in a very timely manner. Other important uses for companion diagnostics include customizing drug dosage based on metabolism biomarker status as well as the ability to monitor treatment.
Companion diagnostics are required to ensure the effective, safe development and use of many personalized therapeutics. Use of molecular and genetic diagnostics to stratify patient populations who would benefit from certain therapies ensures the selection of the appropriated targeted therapeutics based on the patient’s specific profile.
Biomarker Screening and Validation at ResearchDx
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 assist with the pertinent regulatory filings. For commercialization of your diagnostic biomarker, there are multiple pathways that include:
- Assay development customized to your application and exclusively performed in our laboratory
- Custom diagnostic reagents (kitted), manufactured and built on-site and shipped to your global locations to enable third-party use
- Development and validation of your Laboratory — Developed Test (LDT), testing performed on-site at ResearchDx
- Development of in-vitro diagnostic devices (IVD) through regulatory approval for full commercialization, globally
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