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.

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.