Theradiag Launches Two Novel Multiplexed Molecular Diagnostic Assays for Infectious Disease

Regulatory News :

Theradiag (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics, is pleased to announce today that it is distributing two new multiplexed molecular diagnostic assays that each simultaneously test for multiple causes of respiratory viruses and infectious gastroenteritis in a single molecular test.

"These new assays complement our growing portfolio of innovative IVD products using multiplex technology and strengthen our position in the expanding molecular diagnostic market,” said Michel Finance, C.E.O. of Theradiag. "Laboratories and healthcare providers are looking for ways to improve efficiency while managing increasingly complex disease states. Providing faster results from a broad panel makes it easier for physicians to quickly identify appropriate treatment. Better patient outcomes have the potential to reduce hospitalizations and the associated burden on the healthcare system.”

The respiratory assay is a qualitative multiplex molecular diagnostic test for the simultaneous detection of 19 viral types and subtypes from nasopharyngeal swabs, nasal aspirates and bronchioalveolar lavages of individuals suspected of respiratory tract infections. With reduced hands on time and faster workflow, this assay delivers comprehensive front-line respiratory testing in under four hours. A broad assay panel can help identify hard to detect co-infections which can exacerbate other patient conditions.

The gastrointestinal assay is a multiplex test intended for the identification of gastrointestinal pathogens (viruses, bacteria, parasites) causing gastroenteritis. This is the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay which can be an important clinical tool in the management of gastrointestinal disease. It brings physicians a faster and more comprehensive solution to detect gastroenteritis than traditional front-line tests.

Both assays represent innovative testing solutions that help address the physician’s need to identify the causative pathogens to help determine the best therapeutic strategy for improved patient care.

About Respiratory Virus Testing
In clinical setting there are over a dozen respiratory pathogens (viral and bacterial) that are commonly encountered. A clinician needs to know which of these are not infecting a patient in order to effectively prescribe treatment (such as knowing when an antiviral or an antibiotic is likely to be effective), and to control the spread of infection.

Unfortunately, determining the source of a respiratory infection using traditional methods can be challenging and as a result, rather than using a diagnostic test, many physicians send patients with flu-like symptoms home without treatment or else treat them with the wrong medications. It is not surprising then that a New England Journal of Medicine study of children with influenza showed that only 28% of hospitalized and 17% of outpatient children were accurately diagnosed by their physician¹.

About Gastroenteritis
Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms include vomiting and diarrhea, which can be more severe in infants, the elderly, and people with suppressed immune systems. Gastroenteritis can be spread easily through person-to-person contact and contaminated food, water, and surfaces.

Diarrheal disease strikes more than two billion times globally each year, and is a leading cause of child morbidity and mortality worldwide². Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days. For more information visit www.gastroenteritis.com

About Theradiag
Backed by its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostic tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of "customized treatment”, which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has some 50 employees.

For more information about Theradiag, please visit our website: www.theradiag.com¹ Poehling, K. A., K. M. Edwards, et al. (2006). "The under recognized burden of influenza in young children.” N Engl J Med 355(1): 31-40.

² World Health Organization. Diarrhoeal Disease, Fact sheet N°330. August 2009. Available at: http://www.who.int/mediacentre/factsheets/fs330/en/index.html