Reimbursement News In Brief
This article was originally published in The Gray Sheet
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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)
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.