Diagnostic Test for Influenza A+B Cleared
A new rapid test to assess patients for the presence of Influenza A and B, the Flu A+B test, was approved by the U.S. Food and Drug Administration. The test was designed and manufactured by Response Biomedical Corporation. Response Biomedical Corporation issued a press release describing the test approval.
The new diagnostic test is a qualitative immunochromatographic assay. The test is indicated for use as an in vitro diagnostic tool to identify those patients with both Flu A and Flu B nucleoprotein antigens. Specimens are collected with a nasal wash/aspirate or nasopharyngeal swab or aspirate specimens.
The test is assessed with the company’s RAMP 200 Reader. The newly approved test will be marketed by 3M Health Care under the name the 3M Rapid Detection Flu A+B Test.
In addition to approval for the Flu A+B Test, Response also received approval for their updated version of the Ramp Reader, the Ramp 200. This product is also marketed by 3M under the name the 3M Rapid Detection Reader.
The Ramp Reader is the Response diagnostic platform used for both environmental and clinical applications. This is a new approach to the completion of diagnostic assessment and provides high rates of both reliability and sensitivity. An additional benefit is that test results are available in a few minutes.
Executives from 3M note that the Flu A+B test is the first Medical Diagnostics platform test sold in the U.S. Response notes the array of marketing and distribution opportunities through the partnership with 3M Medical Care. The two companies have formed a partnership for the commercialization of rapid test for infectious diseases.
April 28, 2008 Related topics: Product Approval & Certification, Partnerships & Consortia, Diagnostic