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Product Validation and Regulatory Approval

The validation and regulatory submission of a companion diagnostic product requires both analytical and clinical validation studies to be carried out using IUO products. The design and execution of these studies is driven by the intended use for the drug and the test as well as your regulatory submission pathway.

Investigational Use Only (IUO) products

An IUO product is an IVD product that is required for product testing prior to full commercial launch. From our ISO13485 cGMP manufacturing facilities in the UK and North America, Tepnel Pharma Services can support your companion diagnostic development study by the production of investigational use only assays for use in analytical and clinical validation studies.

Analytical validation

Analytical validation represents the next step within product lifecycle management and is required to demonstrate the fitness of an assay, such that the same result will be reproduced using different operators, reagents, labs and equipment. The requirements for these studies are largely driven by the technology being employed as well as the associated guidelines and the intended use of the assay.

For example the Cervista HPV HR test studies showed.[1]

Clinical validation

Regulatory approval of a CDx test generally requires a clinical trial to be run in order to demonstrate the clinical utility of both the companion diagnostic test and the drug. Regulatory bodies ensure accurate, safe, and effective diagnostic tests as evidenced by the multiple FDA approved/cleared diagnostic tests that are on the market which have undergone clinical validation including our PCA3 Prostate cancer diagnostic test.[2] Our Regulatory Team will work with you and the relevant regulatory agencies to determine the best clinical validation strategy for your companion diagnostic product and drug.

Note: The FDA approval of the Progensa PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010. The study enrolled 495 eligible men at 14 clinical sites. Premarket Approval Application (PMA) was submitted to the FDA in August 2010 and the Progensa PCA3 assay was approved in February 2012.


In today’s precision healthcare arena the importance of having a diagnostic partner with a truly global presence cannot be underestimated. The ability to gain regulatory approvals in multiple countries is instrumental to the success of any treatment and its associated companion diagnostic.

The guidance of our Regulatory Team will occur throughout the entire product development process and will be key to the success of the project. Our service is designed to meet the requirements of the FDA and other global regulatory bodies by supporting the regulatory approvals / registrations of your companion diagnostic in any country.




[1] Analytical performance of the Investigational Use Only Cervista HPV HR test as determined by a multi-centerstudy., J ClinVirol. 2009 Jul;45Suppl 1:S63-72. doi: 10.1016/S1386-6532(09)70010-1.

[2] PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study. J Urol. 2013 Jul;190(1):64-9. doi: 10.1016/j.juro.2013.02.018. Epub 2013 Feb 14.

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