Clinical Validation
Gene by Gene’s aim is to work with clients to develop a clinical validation that will allow them to market their test as a CAP/CLIA laboratory developed test (LDT).
Inquire Online
Gene by Gene’s aim is to work with clients to develop a clinical validation that will allow them to market their test as a CAP/CLIA laboratory developed test (LDT).
Enquire OnlineWe develop clinical validations for personalized medicine, biotechnology and pharmaceutical companies.
Before a clinical test may be used, laboratories must demonstrate that the test will consistently perform as expected.
How we work with you:
- We work with clients to develop a validation outline for their test
- We perform the validation study and a written assessment of the test’s analytical accuracy, precision, reportable range, analytical sensitivity, and analytical specificity
- Clinical validity (evidence supporting their test, software/algorithms etc) will need to be supported and performed by the client
Sample Requirements
Depending on the test, we may do both the analytical wet/dry lab studies or, may only do the wet lab studies (i.e. array, NGS, PGx).
The dry lab (bioinformatic, post-data analyses) portion may be performed by the client, depending on what final result/report they want to generate.
Results
Shipping
Testing Methodology
Turnaround Time
10-15 business days
Price
Inquire for pricing
Product Brochure
Submit the adjacent Test Request Form and our laboratory will be in touch to confirm your inquiry.