NETesting assesses gene expression profiles in neuroendocrine tumor patients. Testing is performed only at the CLIA-certified clinical laboratory* at Wren Laboratories in Branford, Connecticut.
The NETest is based on real-time quantitative polymerase chain reaction methodology (qRT-PCR) (Higuchi et al., 1992) using RNA isolated from peripheral blood. qRT-PCR is a proven methodology for sensitive, specific and reproducible gene expression measurement.
Wren Laboratories has optimized and standardized the performance of the NETest processes and implemented extensive quality control procedures that ensure reproducible and reliable testing results.
Quality Control Testing
The relative expression of all genes used in NETesting provides data that assesses the quality of all aspects of the testing process. These include:
- RNA quantity and quality: There must be a sufficient quantity of purified RNA to perform all qRT-PCR reactions. The RNA must also meet acceptance criteria for purity, which includes testing for the presence of excess genomic DNA, which can interfere with gene expression measurement.
- Gene-specific measurement ranges: The measured quantity of each gene product must fall within established ranges.
- Efficiency of the qRT-PCR: The output of the polymerase chain reaction process, expected to double the target material every cycle, must fall within defined limits.
- Precision: Each of the genes tested must be within an established precision specification.
Laboratory Accreditation Certification*
- CLIA # 07D2081388 (expires 2/23/2019)
- State of Connecticut Clinical Laboratory License CL-0704 (exp. 12/31/2018)
- Florida State License 800027786, certificate 101250 (exp. 8/18/2018)
- Pennsylvania State Laboratory ID: 34347 (exp. 8/15/2018)
- California State Laboratory ID: COS00800634 (exp. 9/27/2018)