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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Cook hemostasis spray: Early results of a safety study conducted in China show firm's endoscopic spray helps patients with peptic ulcer bleeds achieve hemostasis and stops re-bleeding, Cook reports April 7. Featuring a proprietary powder that can be sprayed directly onto a bleeding ulcer through the channel of an endoscope, the product may offer an alternative to devices like heating probes and clips in treating gastrointestinal (GI) bleeding, Barry Slowey, global business unit leader for Cook's endoscopy unit, said in an interview. Depending on the results of the 20-patient safety trial, which will be presented at the 2010 Digestive Disease Week conference in May, Cook will decide whether to move forward with a larger clinical study of the spray for GI bleeding by mid-year. About four to five million patients are treated annually for GI bleeds, representing a market of $160 million, Slowey noted

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CDC updates TB guideline

Centers for Disease Control and Prevention updates its 1guideline on using interferon gamma release assays (IGRAs) to detect Mycobacterium tuberculosis infection to include Cellestis' QuantiFERON-TB Gold In Tube test and Oxford Immunotec's T-Spot.TB test on June 25. The original guideline was issued in 2005 after Cellestis' first IGRA was approved, but the document needed to be updated after FDA approval of the two newer tests, which have different antigens, methods and interpretation criteria. The guideline also now reflects more recent literature on IGRAs. CDC says that either of the IGRA blood tests may be used to detect M. tuberculosis infection, with certain exceptions. For example, while IGRAs are preferred over traditional tuberculin skin tests (TSTs) for testing populations like the homeless and drug users, who have historically low rates of return for TST results, TSTs are preferred in children under five years old. A meta-analysis published in April confirms that IGRAs are more effective than TSTs (2"The Gray Sheet" April 12, 2010)

CDC updates TB guideline

Centers for Disease Control and Prevention updates its 1guideline on using interferon gamma release assays (IGRAs) to detect Mycobacterium tuberculosis infection to include Cellestis' QuantiFERON-TB Gold In Tube test and Oxford Immunotec's T-Spot.TB test on June 25. The original guideline was issued in 2005 after Cellestis' first IGRA was approved, but the document needed to be updated after FDA approval of the two newer tests, which have different antigens, methods and interpretation criteria. The guideline also now reflects more recent literature on IGRAs. CDC says that either of the IGRA blood tests may be used to detect M. tuberculosis infection, with certain exceptions. For example, while IGRAs are preferred over traditional tuberculin skin tests (TSTs) for testing populations like the homeless and drug users, who have historically low rates of return for TST results, TSTs are preferred in children under five years old. A meta-analysis published in April confirms that IGRAs are more effective than TSTs (2"The Gray Sheet" April 12, 2010)

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