CIRION Research Inc., a leading provider of large molecule bioanalytical testing and global central laboratory services, announced that the company is now offering new testing services for the screening and clinical diagnosis of COVID–19 and expands its existing laboratory facilities by more than 7,500 sq.ft. (700 sq.m.), bringing its research infrastructure to more than 35,000 sq.ft. (3,250 sq.m.).
The detection of the SARS-CoV-2 virus RNA is a prerequisite for the diagnosis of an acute infection with this new coronavirus (COVID-19). CIRION implemented the TaqPath™ COVID-19 Combo multiplex rt-PCR assay for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory tract specimens. In addition, CIRION is now offering the Roche Diagnostics Elecsys® Anti-SARS-CoV-2 immunoassay running on its high-throughput testing platform for the qualitative detection of antibodies (including IgG) to SARS-CoV-2 in human serum and plasma. This assay is intended as an aid in the determination of the immune reaction to SARS-CoV-2 infection. These assays are approved as in-vitro diagnostic kit by the FDA and Health Canada authorities and are CE–marked.
With these new testing services, which are added to the wide range of biomarkers offered by CIRION, its logistical capacity and their laboratory facilities recent expansion, CIRION increases its capacity to support its pharmaceutical clients for clinical research projects including those related to COVID-19. These new testing services are also offered to the support of patients from public and private health organizations, for corporations interested in identifying infected employees to mitigate the business risk related to an outbreak of COVID–19, and for international travelers to countries requiring certification of a negative SARS-CoV-2 test.
About CIRION BioPharma Research
CIRION is a knowledge-based GLP-certified contract research laboratory specializing in large molecule bioanalysis and global central laboratory services. CIRION provides immunogenicity, cell-based and biomarker assays to biopharmaceutical organization worldwide to support the development of biologics and biosimilars. This includes assay development and validation, and sample analysis (GLP and non–GLP) for all phases of drug development. CIRION’s development capabilities are supported by its global central laboratory services, providing management of multinational and multicentric clinical research projects, including kit production and management as well as logistical, clinical laboratory testing and specimen storage services worldwide through its network of CAP–accredited central laboratories. Certified by the Standards Council of Canada (SCC) as a GLP facility, CIRION is also accredited by the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendments (CLIA), being able to provide clinical laboratory services throughout the United States. Finally, CIRION holds licenses in laboratory medicine from the national regulatory authorities.