Q: How many genomic laboratories does IQVIA Laboratories have?
A: We operate out of state of the art facilities with locations in North Carolina, USA, Edinburgh, Scotland, and Beijing, China.
Q: What certifications do your genomics laboratories have?
A: Our USA laboratory is a CLIA-certified and CAP-accredited genomics laboratory that has undergone frequent, successful audits from multiple sponsors, and was inspected by the FDA in 2017 with no findings. Our Beijing laboratory was accredited by CAP in 2005 and was the first in China to achieve CAP ISO 15189 accreditation. The site passed a US Food and Drug Administration (FDA) inspection in March 2016 without any findings and CFDI has inspected our facility more than 50 times since September 2016. Our Edinburgh laboratory is also CAP and CAP ISO 15189 accredited.
Q: Do your genomic laboratories have a documented process to maintain the chain of custody of submitted samples?
A: Yes; Upon receipt, all packages and samples are inspected for intactness and temperature. Any visible damage to package and/or samples, loss or depletion of dry ice is recorded according to study documentation requirements. Any sample labeling discrepancies are identified and reported immediately. We have worked with barcoded samples labelled by a central lab or clinical site. In addition, all samples receive a unique identifier upon receipt.
Samples may be put on hold if there are discrepancies found during accessioning. Common discrepancies include sample labeling or discrepancies between the sample label and manifest. We will work with the primary client contact to resolve any discrepancies. We will not contact individual study sites for any sample discrepancies. Any issues or deviations would follow the agreed communication schedule for a particular study, in accordance with our quality manual, with communication originating from the project manager.
Information on each specimen will be imported into the Laboratory Information Management System (LIMS) and into our freezer management tool for detailed tracking of sample flow throughout the lab.
Specimens will be tracked using barcodes and individual nucleic acid specimens will be assigned a unique identification number. If samples should arrive in plate format, the individual specimens will be assigned an identification number based on a unique plate barcode assigned by IQVIA Laboratories | EA Genomics for the specimen position within the plate. (For example: a specimen in well A01 of plate 1000 would be assigned specimen ID#1000-01A.)
This identifier and its descendant identifiers are propagated through the entire workflow via barcoded labels. For final data delivery we deliver with both the original client sample ID as well as the unique identifier assigned upon receipt.
Our LIMS database and chain of custody logs carefully track every sample from accessioning to final sequencing library or other assay final sample format. Missing sample data is identified by total counts prior to data delivery. Problem samples are tracked in a failure log.
Q: Do your genomic laboratories offer assay development or assay transfer services?
A: IQVIA Laboratories Translational Genomics team is expert in validating the transfer of assays into its portfolio or from one facility to another, executing on commercially available panels or assays, and the development and validation of bespoke assays. Our assay development team frequently works with clients to develop custom solutions. In 2017, IQVIA Laboratories delivered approximately 70 sponsor driven assays, from development through validation. We have deployed 7 of these assays globally. IQVIA Laboratories believes that this expertise in custom assay development, companion diagnostic support, optimization, validation, and deployment sets us apart in the clinical trial specialty lab services space.
In addition, IQVIA Laboratories offers expertise in optimization of existing assays and methods to understand the potential to improve data quality and project performance. This includes techniques from published literature, as well as new commercially-available kits. Validated methods are often revisited to identify opportunities to optimize processing from a data quality or operations standpoint. In the event that a validated method is modified, it will undergo additional validation testing commensurate with the nature of the modifications and undergo monitoring to ensure performance is not negatively impacted.
Q: Does IQVIA Laboratories offer pricing or volume discounts?
A: IQVIA Laboratories is committed to providing cost competitive pricing and volume discounts and has a demonstrated ability to extend savings derived from bulk discounts and volume-based efficiencies.
Q: Do your genomics laboratories offer anatomic pathology services?
A: Our scientific staff is organized into development and production groups, with the latter including dedicated staff for accessioning, anatomic and molecular pathology, nucleic acid isolation and pre-analytical quality control, genomics analysis, and bioinformatics data processing and delivery.
IQVIA Laboratories provides interpretation of H&E staining onsite. Anatomical Pathology Services offered in support of genomic testing include:
- FFPE block re-embedding
- FFPE block cutting – slides and/or curls
- H&E staining
- H&E evaluation (multiple levels of complexity based on evaluation requested) – both H&E slides and digital images
- Digital imaging (Aperio ScanScope)
- Digital macro-dissection (use of digital image with paired unstained slides)
Q: What is your standard turnaround time?
A: Turnaround times are dependent on various factors and a sponsor’s needs. Expedited turnaround times are available. For more information on the turnaround time for any given project, please contact our team.
