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Quest Diagnostics gets European CE Mark for H1N1 (Swine) Flu Test

Posted Nov 19 2009 10:01pm

The test has been approved here in the US by emergency declaration a few months ago.  Quest recently posted 3rd quarter profits of 1.9 billion so they are doing a lot of tests.  I did a short interview with their VP of sales with MedPlus, the IT connection with the company not too long ago and you can read more at the link below. 

Quest Diagnostics and Health IT – Interview with Rohit Nayak, Vice President of Sales, Clinical Information Solutions Group, MedPlus

Quest Diagnostics Inc. (DGX) can now let you know if it's safe to be out in crowds on both sides of the pond.

The Madison, N.J.-based healthcare conglomerate announced that European regulators have approved its Simplexa test for Influenza A H1N1 (2009) virus, better known as Swine Flu. Developed through its Focus Diagnostics unit, the new test kit is getting its initial rollout this week at the MEDICA 2009 conference in Busseldorf, Germany.

The new test uses reverse-transcription polymerase chain reactions found from nasal and throat samples to detect the flu virus. Physicians have lauded its speed, noting that "fast turnaround time(s) can aid in clinical management of patients and allow hospitals to segregate infected patients from other high-risk individuals," according to Dr. Harald Kessler, head of the molecular research unit at the Medical University of Graz, Austria.

The CE Mark allows sales throughout the 35 countries of the European Union and in other countries that recognize the mark. Test is also available in the U.S. under an emergency provision from the Food & Drug Administration.

Quest Diagnostics gets CE Mark for Swine Flu test | MassDevice - Medical Device Industry News

Related Reading:

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