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Biotech / Medical : QDEL - Quidel more quick diagnosis
QDEL 27.43+1.2%Nov 5 3:59 PM EST

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To: Peter Caradonna who wrote ()8/31/1999 1:17:00 PM
From: ken whited  Read Replies (1) of 1693
 
Qdel better get busy!

FDA Approves Quick Pneumonia Test

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W A S H I N G T O N (AP)

THE FOOD and Drug Administration has approved a 15-minute pneumonia test that uses a patient's urine to detect a bacterium called Streptococcus pneumoniae blamed for an estimated 500,000 cases of pneumonia a year.

The Binax Inc. test approved Monday should help doctors decide more quickly whether a patient's pneumonia is caused by that bacteria, and thus what treatment is needed.

That's important because of a growing army of bacteria that are impervious to antibiotics. Just this month, the government announced that infections caused by antibiotic-resistant Strep pneumoniae are on the rise.

Antibiotics have no effect on viruses. They kill only bacteria. But symptoms alone don't let doctors tell whether pneumonia is caused by a virus or bacteria.

Conventional pneumonia tests analyze either phlegm or blood and can take two to three days to more than a week. Consequently, doctors often prescribe antibiotics to be safe - the best decision for a patient with bacterial pneumonia but an unnecessary exposure to antibiotics for patients whose pneumonia was caused by a virus.

Unnecessary use of antibiotics leads other bacteria in the body to evolve resistance to the drugs. That could mean that if the patient were to contract a bacterial infection later, antibiotics might not help.

Binax's new pneumonia test detects an antigen, or protein, present on bacterial cells that gets into patients' urine soon after symptoms appear. The antigen acts as a marker for strep-caused pneumonia.

Doctors simply stick a swab into a patient's urine sample and put it on a special reactive strip that within 15 minutes signals whether it detects the strep antigen.

Portland, Maine-based Binax said it was ready to ship the tests to doctors' offices immediately. They will cost doctors $15 to $20.

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