Custom Assay Development
As part of their clinical diagnostics specialties, the Research & Development Team at Sorenson Genomics routinely partners with academic institutions and clients large and small on custom assay development and the subsequent supportive tailor-made test types. Custom Assay development includes custom panels which may be Y-STR or protein, for example. The Sorenson team works closely with clients on custom assay development and the necessary validation of these novel molecular diagnostic assays for clinical diagnostics or research use. These valuable esoteric tests may be used for clinical trials and can be performed in-house at our Human Genomics DNA Testing Laboratory.
The Gold Standard
IDENIGENE® STD Test Collection Kit for chlamydia and gonorrhea.
Our Research & Development Team is active in the development of technology suitable for clinical diagnostics and testing. Sorenson Genomics is helping to fuel the rise of STD awareness with a first-to-market and direct-to-consumer STD Test Collection Kit for chlamydia and gonorrhea, the two most common bacterial STDs. This clinical diagnostic test kit is currently in clinical trials with the Food and Drug Administration (FDA) awaiting final approval for distribution. The clinical diagnotics' gold standard method is the Nucleic Acid Amplification Test method (NAAT)--the same laboratory assay utilized by hospitals and clinics. Sorenson Genomics will utilize the NAAT method in its STD Test Collection Kits.
Clinical Laboratory Improvement Amendments (CLIA)
The Clinical Laboratory Improvement Amendments (CLIA) regulates all laboratory testing (except research) performed on humans in the U.S. These stringent requirements provide clients with confidence in the quality and reliability of laboratory results. The Human Genomics DNA Testing Laboratory at Sorenson Genomics is accredited to CLIA standards through the College of American Pathologists (CAP). View our CLIA Certificate of Accreditation. Clients benefit from our strict and highly decorated accreditation standards.