22 Sep EraGen receives Health Canada's approval of molecular diagnostic test
Madison, Wis. – EraGen Biosciences today announced it has received Health Canada approval to market five molecular testing products as in vitro diagnostics in the Canadian market.
The approved EraGen molecular diagnostic tests are performed on the company’s easy-to-use MultiCode®-RTx real-time PCR system. The MultiCode®-RTx system simplifies and enhances traditional real-time PCR through the use of EraGen’s patented synthetic base pair, iC and iG. The system provides clinicians and laboratories with more efficient laboratory workflow, reduced time to test result, and the flexibility to run EraGen tests on virtually any quantitative PCR instrument.
The EraGen molecular diagnostic tests approved by Health Canada are:
· Bordetella pertussis and parapertussis, the cause of highly-contagious whooping cough and related disease
· Enterovirus, which causes meningitis, among other diseases, and is second only to the “common cold” viruses as the most common viral infectious agents
· Influenza types A and B, the viruses that cause the flu and, in more serious cases, pneumonia
· Herpes simplex virus (HSV) 1 and 2, the cause of recurring infections that produce sometimes painful blisters and sores on the body
· Cytomegalovirus (CMV), the most common infectious agent present at birth and a major threat to solid-organ transplant patients
“Health Canada’s approval of five EraGen molecular diagnostics is another significant step forward in the execution of the company’s product commercialization strategy,” said Irene Hrusovsky, M.D., president and chief executive of EraGen. “We are committed to expanding our molecular diagnostics business into multiple rapidly-growing markets outside of the United States.
“These Health Canada approvals reinforce EraGen’s commitment to international expansion and demonstrate that the company is well equipped to execute on all the critical elements of product commercialization. We look forward to serving clinical laboratories across Canada with all the advantages of our MultiCode®-RTx system and to providing additional options on that platform through the ongoing expansion of our product menu.”
About EraGen Biosciences
EraGen Biosciences Inc. develops, manufactures and markets molecular reagent products that are driving a new era in clinical diagnostics. The company’s in-market and pipeline products, based on its novel, patented MultiCode® platform chemistry, are the next generation of DNA- and RNA-based testing for the early detection of infectious diseases and genetic-based conditions. EraGen’s expanding menu of high quality, easy-to-use products position the company for leadership in the molecular diagnostics market.