DIASORIN RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR THE FIRST, FULLY-AUTOMATED ZIKA IGM TEST

April 06, 2017 – Saluggia (VC) – DiaSorin (FTSE Italia Mid Cap:  DIA) is pleased to announce that   it has received FDA Emergency Use Authorization (EUA) for the LIAISON® XL Zika Capture IgM assay,  a first-of-its-kind, fully-automated serology  assay for the detection of Zika virus infections.

“Leveraging over 40 years of infectious disease immunoassay product development and commercialization we were able to develop a first-of-its-kind assay for Zika virus  IgM  detection”, said John Walter, President of DiaSorin Inc. “Using the proven LIAISON® XL platform along with an innovative assay format, utilizing the Zika NS1 antigen, DiaSorin was  able  to produce  an  assay that yields results in as little as  37 minutes  after the specimen is placed on the platform.”

The LIAISON® XL Zika Capture IgM assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria. Specimens used with the LIAISON® XL Zika Capture IgM Assay should be collected between 8 days and 10 weeks after onset of symptoms or risk of exposure.The assay is intended for use in laboratories in the United States that are certified 1 to perform high or moderate complexity tests, or by similarly qualified  non-U.S.  laboratories,  consistent with the latest CDC testing algorithms for the diagnosis of Zika virus infection. This test  has not been FDA-cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The most common symptoms of Zika are fever, rash,  joint pain,  and conjunctivitis, or red  eyes.  The illness usually is mild with symptoms lasting for several  days  to a week.  People typically do  not get sick enough to require hospitalization and they very rarely  die  of  Zika.  For  this reason, many people might not realize they have been infected. However, Zika virus infection during pregnancy can cause a serious birth defect called microcephaly, as well as other severe fetal brain defects.

Funding for the LIAISON® XL Zika Capture IgM assay was provided by the U.S.  Department  of Health and Human Services, which granted DiaSorin a $2.6 million contract in the fall of 2016. The project is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority  (BARDA),  under Contract  No. HHSO1002016000027C.

Carlo Rosa, CEO of DiaSorin Group, commented “I am extremely proud  for the excellent job done by our US R&D team based in Stillwater (MN) in achieving this important milestone. Also,  I would like  to  thank  the  US  Department   of   Health  and  Human  Services  for  the  continuous  support provided to DiaSorin during the development of this very  innovative assay.  Authorization  of  our Zika test confirms our Group’s ability to continuously innovate in the immunoassay market, providing sound and reliable solutions to customers around the globe to rapidly diagnose harmful diseases and support physicians to provide better care to patients.”

1 under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a

 

 

 

 

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