DiaSorin S.p.A launched FDA cleared Simplexa Bordetella direct molecular test in the United States. The test is intended to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in human nasopharyngeal swabs. The same test was already launched in European market in 2017.
According to the World Health Organization, Pertussis i.e. whooping cough is a highly contagious disease of the respiratory tract caused by Bordetella pertussis affecting people of all ages. Particularly infants are more prominently affected that can result in hypoxia, permanent brain damage or death. According to the Center for Disease Control and Prevention, globally approximately 24.1 million cases of pertussis and about 160,700 deaths per year has been reported.
Name: Michelle Tabb
Designation: Vice President of Research and Development, DiaSorin Molecular LLC
“Whooping cough can be detected among all age groups and has seen a resurgence in recent years. We are very excited about our addition of the Simplexa Bordetella Direct assay as it will help in the detection and appropriate treatment of this infectious disease also in United States. The assay, designed for the use on the LIAISON MDX platform, meets the needs of today’s laboratories by detecting both B. pertussis and B. parapertussis with a simple workflow.”
According to the Axiom Market Research & Consulting‘s market research analyst the launch of new assay due largest number of cases reported for pertussis in the United States will have a positive impact on the market. The molecular diagnostic segment is expected to propel at a CAGR of 8.6 % during the forecast period of 2015-2020. The increasing use of molecular diagnostics to diagnostic and treatment of diverse diseases and increasing adoption of advanced diagnostic techniques will also have influence the market growth.
DiaSorin S.p.A was founded in 1968 and headquartered in Saluggia, VC Italy. It is a biotechnology based company operating its business in healthcare, biotechnology, in vitro diagnostic, immunoassay, molecular diagnostic, blood tests, GI stool testing, vitamin d, prenatal screening, and infectious diseases. The company develop, produce and market reagent kits for IVD globally and has its presence in continents with 25 companies, 5 foreign branches, 6 manufacturing facilities and 5 research centers worldwide. The research and development department is focusing on new test in molecular diagnostics to increase efficiency, enabling better management of patients with fast, reliable and clinically actionable assay results.