HEALTH

3M introduces Rapid Detection flu test

BY Michael Johnsen

ST. PAUL, Minn 3M on Thursday announced the nationwide availability of the 3M Rapid Detection Flu A+B Test, an innovation in the flu diagnostics market.

The 3M Rapid Detection Flu A+B Test is the first rapid flu test to provide automated results. The automated technology helps reduce user interpretation errors, which can lead to both false-negative or false-positive results. The 3M Rapid Detection Flu A+B Test will be able to deliver hospital and physician office laboratories reliable and objective electronic results in 15 minutes.

“Bringing automation to the interpretation of influenza tests is a key factor for the next generation of rapid flu tests,” said Brian Anderson, marketing manager of 3M Health Care. “Automating and storing the objective result of a flu test will help increase laboratory productivity and minimize the potential for human error, which can contribute to improving patient outcomes.”

Requiring less than three minutes of prep time, the 3M Rapid Detection Flu A+B Test detects positive or negative results and differentiates influenza A and influenza B. In addition to providing automated results, the technology also enables labs to export data through laboratory information systems, further reducing the potential for reporting error by eliminating the need for manual recording and transferring of patient results. The test also reads and stores lab results, giving lab technicians more flexibility in time and test management.

“Properly interpreting test results is critical, especially considering that most flu antiviral medications have a 48-hour recommended therapeutic window for prescribing, so false-positives or even delayed test results may result in misapplication of therapy or may reduce its effectiveness,” stated Christine Ginocchio, director of microbiology, virology and molecular diagnostics at North Shore Long Island Jewish Health System. “Having an automated reader almost eliminates the potential for misinterpreting results, leading to a faster and more informed treatment decision, which results in better patient outcomes.”

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GlaxoSmithKline wins recommendation to sell Alli in Europe

BY Michael Johnsen

LONDON GlaxoSmithKline won a recommendation from European regulators Thursday that it be allowed to sell its weight loss drug Alli over-the-counter in Europe.

The European Medicines Agency said it had recommended the switch from prescription-only to nonprescription for a 60-milligram dose of alli, the same dose approved for sale OTC in the United States. The European Commission now needs to rubber-stamp the recommendation.

The European Medicines Agency said it had recommended the switch from prescription-only to nonprescription for a 60-milligram dose of alli, the same dose approved for sale OTC in the United States. The European Commission now needs to rubber-stamp the recommendation.

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FDA endorses industry iniative to update children’s cough-cold product labeling

BY Michael Johnsen

ROCKVILLE, Md The Food and Drug Administration on Wednesday issued a consumer update regarding the use of cough/cold products in children that reinforces the agency’s support of an industry initiative that changes label recommendations on pediatric cough/cold products to no longer recommend use in children under the age of four, and explains the reasoning behind why the agency hasn’t requested an immediate product recall of current labeling.

“The voluntary actions announced by the Consumer Healthcare Products Association are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use,” the agency stated. “CHPA’s voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state ‘do not use’ in children under 4 years of age, while others will instruct not to use in children under 2 years of age. FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.”

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