Assay Development

Meeting Complex Requirements

ResearchDx offers state-of-the-art custom and molecular assay development, from concept and biomarker discovery through clinical validation and regulatory approval to final kit manufacturing. We can step in at any stage to support your project needs. The ResearchDx team is highly skilled in all project phases associated with regulated and non-regulated environments in the United States and abroad, supporting diagnostic development partnerships worldwide. We offer a diverse array of platforms and technologies and can support all development and testing needs, molecular and non-molecular. An example list of platforms and technologies we support is found here. Since 2015, we have validated over 300 new assays and performed millions of tests for our clients in the US and internationally.

Exceptional Assay Development Specialists

Our Pharma and biotech companies request increased complexity and shortened turnaround times for central laboratory services and testing requirements, including disease and drug-specific biomarker assessments and biomarker assay development to determine the safety and efficacy of compounds in development. ResearchDx remains committed to continually expanding our capabilities to address these growing demands. Our development team is staffed by dedicated scientists and fully equipped with state-of-the-art technologies and standardized instrumentation. Our R&D support includes expertise in fluid, tissue, cell-based, and molecular assay development for biomarker testing and a range of methodologies to address a study’s specific biomarker and assay development demands.

Assay Development

ResearchDx has developed hundreds of assays for our clients for every conceivable application. Some of these applications have included:

Research grade assays for Biomarker discovery
CLIA validated assays for a Phase 2 companion diagnostic
GLP-validated assays for the evaluation of safety and efficacy.
ISO-13485 manufactured diagnostics for worldwide clinical trials
510(k) cleared and PMA-approved complementary and companion diagnostics

Our Clinical Laboratory Consulting Services

CLIA licensure applications and changes
CAP and ISO 15189 certification licensure applications and changes
State-specific (CA, NY, FL, etc) licensure applications
Provision of contracted Laboratory Directors, and Clinical and Technical Consultants
Evaluation of laboratory director, clinical / technical consultant, and personnel qualifications
Mock CLIA and accreditation inspections, and GAP analysis
Responses to CLIA standard and condition level deficiencies
Responses to CAP and ISO 15189 audits
CLIA compliant Quality Management System.
Provision of standard laboratory SOP’s
Provision of logs for reagent inventory, temperature, QC, and patient testing
Guidance and review of requisitions and reports
General guidance for CPT coding
Enrollment in proficiency testing

Our Turnkey CLIA Certification Services

CLIA certification
Compliant Quality Management System
Electronic Document Control System
Assistance with all required clinical laboratory forms and templates
Expert guidance on technical SOP content
Assistance with initial assay validation and verification
Initial onsite audit, progress visits, pre-inspection mock audit
Inspection day guidance and assistance
Post-inspection deficiency correction
Interim Laboratory Director as needed.
Post licensure/accreditation quality management review and follow-up

What Level of Validation Do I Require

Research Assays:

Research grade tests are usually utilized in universities or “biomarker discovery” settings. There are no specific recommendations for Research level validation. Still, at ResearchDx, all validations include an assessment of accuracy, precision, detection limits and reporatble range sufficient to demonstrate the assay is suitable for the intended use.

GLP Validation:

The objective of assay validation is to demonstrate the assay is suitable for the intended use. The regulations do not outline the requirements for validation. Still, at a minimum, a GLP validation will include documentation of accuracy, precision, and limits of detection, plus any additional studies required to demonstrate “Fit for purpose”. GLP-level assays where the data is intended for FDA submission will require additional studies.

CLIA Assay Validation:

CLIA assays are typically utilized in a routine clinical setting or for clinical studies where the testing has the potential to impact patient care. CLIA clearly defines analytical validation requirements regarding accuracy, repeatability, reproducibility, detection and quantitation limits, reportable range, and interfering substances. CLIA accrediting agencies (Including CAP and A2LA) have specific requirements that may require additional studies.

ISO-13485 Assay validation:

ISO 13485 specifies the requirements for a medical device manufacturer’s quality management system (QMS). The standard outlines the QMS requirements to prove that the manufacturer can produce safe and effective medical devices that meet user needs and comply with all applicable regulations.

510(k) and PMA Validated Medical Devices:

The purpose of a 510k submission is to provide the FDA with documented evidence proving that your medical device is substantially equivalent to a predicate device, which has already been approved for marketing by the FDA. Requirements for an FDA submission include A Documented Design Controls process, including intended use, indications for use, design inputs, design verification, and anlaytical validation studies. Clinical studies may be required for some, but not all 510(k) submissions.

A PMA is more in-depth than a 510k – it proves that a new device is safe and effective for the end user. It typically requires clinical trials with human participants and analytical validation studies. The standards here are much higher than for 510k submissions, and the FDA has just 180 days to accept or reject the application.

We have over 15 years of experience in custom assay development, we can confidently handle your custom project.