Your Complete Resource for in vitro Diagnostics (IVD) and Companion Diagnostic (CDx) Development
Navigating the development path for FDA-approved companion diagnostics doesn’t have to be complex — it just requires a partner with expertise, experience, and resources who knows the way.
As a Contract Diagnostics Organization (diagnostic-focused CRO), ResearchDx is a unique, integrated business entity that solves logistical complexities associated with multi-partner outsourcing for regulated companion diagnostic development. Unlike traditional development strategies where specialized expertise must be coordinated through multiple vendor organizations, a CDO provides all expertise and services within a single, integrated organization.
Integrated Development of a Drug and a Companion Diagnostic
By integrating and synchronizing all IVD and biopharma development activities, a single ‘start-to-finish’ partner simplifies and speeds the process to complete your FDA-approved companion diagnostic at the right time.
Single Resource — Single Point of Contact
Unlike multi-partner outsourcing, your dedicated project manager at ResearchDx is your point person to guide you through all phases of your project. As an integrated organization, we have built-in flexibility to adapt to your project’s changing needs and priorities with the efficiency of a single-point contact.
Technology & Platform Independence
As an independent laboratory, we are able to evaluate and validate technologies best-suited for your companion diagnostic without bias to any instrument or technology manufacturer. Supporting broad development capabilities on a wide array of platforms, we stay current with the newest advances in genomic platforms and technologies. Working closely together, we will assist in choosing the best commercial strategy for your diagnostics assay.
We are free of relationships with instrumentation manufacturers or the sale or promotion of instrumentation.
Quality System & Validation
ResearchDx meets and maintains compliance per applicable Quality System (QS 21 CFR 820) requirements and specifications for the Food and Drug Administration (FDA) — regulated medical devices (cGMP). All assays developed at ResearchDx undergo rigorous analytical and clinical validation exceeding specific regulatory guidelines set forth by the Clinical Laboratory Improvement Act (CLIA), College of American Pathologists (CAP) as well as the Food and Drug Administration (FDA). Additionally, all projects undergo an independent quality review process to ensure all design specifications have been met.
Regulation of Laboratory Tests
IVD and LDTs: The Facts
The US regulations provide two separate legal paths to enable Diagnostic testing in the USA via the CLIA pathway (laboratory-developed testing (LDT) or through the FDA registration process (510(k), PMA). A summary of the differences is presented below.
In vitro diagnostic test (IVD)
Developed for sale to third-party diagnostic laboratories, health clinics, or consumers
Standardized instrument qualification procedures and training required
The assay is locked down and cannot be improved without additional FDA submission and review
The assay must be developed per 21 CFR Part 820 compliance requirements for medical device companies
Must be pre-validated and approved (PMA) or cleared (510(k) with the FDA before testing.
Laboratory-developed test (LDT)
Implmented by individual laboratories for single facility use; Not to be transferred, licensed, or sold to other labs.
Individual labs establish instrument qualification, assay validation, and training requirements.
Must be clinically validated before use and must comply with the Clinical Laboratory Improvement Amendments (CLIA) of the U.S. Centers for Medicare and Medicaid Services.
IVD Assay Classification
- Class I products are considered low to moderate risk and require general controls.
- Class II products are considered moderate to high risk and require general controls and Special Controls.
- Class III products are considered high risk and require general controls and Premarket Approval (PMA).
IVD Assay Premarket Requirements
There are two main premarket review pathways for products – premarket notification and PMA.
- Premarket notification
This is the less stringent of the two and is meant for Class I and some Class II devices similar to existing products on the market.
- Premarket approval
PMA is a more stringent process that requires the manufacturer to demonstrate the safety and effectiveness of the product.
This pathway is meant for most Class II and all Class III devices as they pose a high risk to patients. It’s also meant for state-of-the-art devices (i.e., devices that aren’t similar to any existing product on the market).
Service & Support
We have gathered scientific and medical expertise in all areas of diagnostics to ensure projects are designed and implemented and stay on target with all priorities and schedules. Our operation is supported by a fully accredited and licensed clinical laboratory to support all research and assay development and clinical and esoteric testing activities.
Our GxP-compliant, CLIA-licensed and CAP-accredited laboratory, PacificDx offers state-of-the-art facilities and expertise to meet your immediate clinical and pre-clinical needs for high-quality clinical and biopharmaceutical testing services.