Quality Control

Accurate interpretation of your experimental data depends on the quality of the tissue or tissue-derived product, as well as the quality of the associated data annotation. Our quality system encompasses all aspects of the biospecimen life cycle from collection and pathology evaluation through derivative processing and product distribution.

Tissue Collection

• OriGene believes that the proper collection and use of human biospecimens begins with the complete protection of the rights and privacy of the individual.
• All samples are collected under IRB approved protocols
• All human subjects are fully informed and are explicitly asked for their consent to future research use of their samples, even in cases where such uses are unknown at the time
• De-identified and coded patient numbers (Case IDs) ensure the privacy of our donors in accordance with the Health Insurance Portability and Accountability Act (HIPAA)
• Samples are collected from a diverse set of medical institutions throughout the United States in order to maximize patient diversity
• Frozen samples are embedded in OCT media to facilitate sectioning and pathology verification
• Stringent collection techniques minimize artifactual results

• Detailed pathology reports are abstracted and meticulously reviewed to confirm patient diagnosis
• Standardized clinical ontology imparts greater confidence in product selection
• A pathologist performs a microscopic evaluation of each and every sample to ensure the accuracy of the sample level diagnosis (i.e., a normal adjacent sample collected from a cancer patient) and detail the sample’s cellularity (% normal cells, % lesion cells, % tumor cells, % stroma and % necrosis)
• Confirmation and description of the tissue of origin and site of finding is provided for every sample
• OriGene provides a highly detailed presentation of sample data including hyperlinks to abstracted pathology reports and digital H&E images.
• Clients may elect to work interactively with a customer service professional to identify the most appropriate samples for a given study
• Secure, convenient downloading of sample presentations via OriGene ServiceWeb

• The OriGene Biorepository employs numerous practices and features designed to minimize the likelihood of an event that could result in the loss of sample integrity
• All sample movements within the Biorepository are 100% traceable making it possible to quickly and easily review the current location as well as the entire location history of each and every sample in the Biorepository
• Redundant AC: Building and additional heat exchangers
• Auxiliary power: Diesel generator activated within seconds of a power outage
• 24 hour monitoring of ambient and freezer temperatures, power and noise levels and automated telephone notification in the event of a deviation
• 24/7 emergency freezer service and freezer re-location service

• Each sample is carefully reviewed by a pathologist prior to derivative extraction. The description of the source sample cellularity along with digital images of the H&E slide are provided for each sample
• Our highly purified total RNA is suitable for gel based analysis, real-time PCR analysis and microarray analysis
• RNA quality is assessed using an Agilent Bioanalyzer
• RNA 28S/18S ratio, Agilent Bioanalyzer electropherogram (in .jpg format) and RIN score (coming soon) are provided for each sample
• RT-PCR is performed for each sample to demonstrate suitability for cDNA based expression analysis and the absence of contaminating genomic DNA
• All sectioning work is performed by ASCP licensed histologists
• Proven, rigorous protocols ensure that frozen tissue is not allowed to thaw during the cutting, storing and shipping processes
• Each sectioning order is reviewed by a pathologist prior to shipment to ensure that freeze artifact is not present (in frozen samples) and that the cellularity is representative of the source block

• The OriGene Biorepository has served as a hub for the collection, management and distribution of nearly 200,000 biospecimens
• All Biorepository personnel are specifically trained and certified for the handling of class 6.2 dangerous goods
• All shipments sent from the OriGene meet or exceed International Air Transport Association (IATA) guidelines