Siemens is First Laboratory Diagnostics Company to Achieve FDA Clearance for New Molecular Allergens

Siemens Healthcare Diagnostics announced today FDA clearance of twenty one 3gAllergy™ allergens for use on its IMMULITE® 2000 Immunoassay System, including approval of eight new molecular allergens never before available in the U.S.

Today, most in vitro allergy testing uses allergen extracts, which are a mixture of both allergenic and non-allergenic protein antigens. Molecular allergens utilize isolated individual proteins or recombinant derived materials that are known to cause allergic reactions. These molecular allergens can help physicians further identify patient sensitization to a specific protein component of an allergen as well as differentiate whether symptoms are caused by a specific allergen or by cross reactivity.

Specifically, the eight new molecular allergens available from Siemens for use on the IMMULITE System 2000 include tests for major allergenic proteins derived from cat dander, dog dander, house dust mites, Aspergillus (mold), and shrimp. With the FDA clearance, these allergens are now broadly available to laboratories and physician offices. Since 2008, ninety specific Siemens allergens have been cleared by the FDA.

“Siemens is excited to not only receive clearance for 21 allergens, but to be the first company to begin offering these new molecular allergy tests to laboratories and clinicians throughout the United States as part of this release,” said Dave Hickey, CEO, Chemistry, Immunoassay, Automation, and Diagnostics IT Business Unit, Siemens Healthcare Diagnostics.

Currently, the Siemens 3gAllergy portfolio includes 419 specific allergens and 55 panels, with 285 allergens cleared by the FDA for use in the United States on the IMMULITE 2000 System. For more information about Siemens’ allergy testing, visit

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