October 2007 Clinical Laboratory News: News From the FDA

October 2007: Volume 33, Number 10

FDA Approves WNV Screening Test

Roche Diagnostics (Indianapolis, Ind.) announced approval of its cobas TaqScreen West Nile Virus (WNV) test. The assay uses PCR technology to directly identify the genetic material of WNV in blood, enabling detection of infected donated blood and organs even before the donors have begun to produce antibodies. Designed to run on Roche’s cobas s 201 system, the TaqScreen WNV test is the second such assay to get the nod from the FDA this year. Gen-Probe’s Procleix WNV assay won approval in March.

Faster PTH Test Cleared

Roche (Indianapolis, Ind.) also announced clearance of its 9-minute parathyroid hormone (PTH) test for use during surgery and as an aid in the identification of thyroid dysfunction. The test quantitates the amount of PTH in human serum and plasma for the diagnosis of hypercalcemia or hypocalcemia. Surgeons can now use the test at intervals to determine if all tumor tissue has been removed and the parathyroid gland is functioning normally again. The assay is available on Roche’s Elecsys 1010 and 2010 systems and cobas e 411 analyzer. It was approved for non-surgical use in April.

Modified HIV-1 Viral Load Test Approved

Abbott Diagnostics (Abbott Park, Ill.) announced FDA premarket approval for its new RealTime HIV-1 viral load test. The assay includes a new design that requires less plasma, as low as 0.6 mL. The assay can quantify HIV-1 in plasma in as few as 40 RNA copies/mL, and it also has the ability to detect and measure all known genetic variations of the virus. FDA approved the initial version of the assay in May, making it the first validated test to detect and precisely measure common strains of HIV-1 as well as all genetic variations.

A related supplemental approval covers an increased testing capacity on the Abbott m2000 automated instrument for use with the HIV-1 viral load test. The new system can process up to 96 specimens in a batch and 192 specimens in one shift. 

FDA Updates FOBT Guidance

A revised FDA guidance on the agency’s review criteria for assessment of FOBTs adds new information about software and immunological tests, updating the original 1992 document. The guidance covers both guaiac and immunological tests, and deals with the separate issues software-controlled analyzers introduce, for which it recommends reading separate guidance documents on validation and verification testing, hazard analysis, and human factors engineering. Clinical studies, method comparison, and labeling are also covered. “Guidance for Industry and FDA Staff: Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices” is available online.





Page Access: