“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Because every person is a genetically distinct individual, the adage “one treatment for one disease” is no longer applicable in the new age of precision or ‘personalized’ medicine. Today, the ability to identify patients who may or may not benefit from a therapy is a key component in personalizing the management of clinical disease and outcomes. Drug selection and dosage may be customized according to individual biological characteristics, genetic alterations, ethnicity, gender and results of diagnostic testing. Diagnostic biomarkers also provide the ability to monitor therapeutic treatment success and failure.
For the biopharmaceutical companies who develop a targeted therapy, the development of a companion diagnostic (CDx) is required by the FDA to stratify the population of patients who may benefit or be harmed by the new novel therapy. Not all patients with the same disease or cancer exhibit the same genetic and biomarker profiles, therefore understanding who will and will not benefit due to underlying causality drives the drug development process and eventually, optimal patient treatment opportunity. New molecular technologies, particularly next generation sequencing (NGS), has become the preferred methodology for novel biomarker discovery and drug target identification efforts. NGS provides a wealth of genomic data that has led to a greater understanding of underlying genomic alterations, mutations and biological pathways that explain disease mechanisms and allow for precise targeting for new drug development.
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